The Senior External Data Specialist (SEDS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the external data group team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. Scope external study data requirements and effort for projects. Project manage all external data related activities across multiple projects. Provide expert advice on the transfer and expected formats of data transfer files. Provide technological expertise and guidance on the best methods for handling laboratory data and other external data. Create and maintain data transfer agreements. Maintain study documentation within project files as appropriate. Act as primary contact and study representative to third party data providers. Effectively communicate transfer requirements and project timelines to various stakeholders. Identify and communicate project risks. Ensure data integrity is maintained by implementing appropriate data controls for masked data. Ensure delivery of timely data transfers and undertake quality reviews and testing activities. Conduct external data reconciliation using available technologies and processes. Raise queries to external data providers and track queries to successful resolution. Provide listings to medical review team. Assess and implement new data review and analysis processes and technologies. Take a lead role in the development of best practices, process improvement, quality control and governance related to all external data matters. Provide training and mentoring to team members in SOPs, software applications, and best practices. Attributes and Skills-Expert domain knowledge and experience within clinical research and drug development. Advanced knowledge in >1 EDC systems and laboratory processes. Experience mentoring and training others. Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities. Excellent analytical, communication and problem-solving skills. Responsibilities The Senior External Data Specialist (SEDS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the external data group team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. Scope external study data requirements and effort for projects. Project manage all external data related activities across multiple projects. Provide expert advice on the transfer and expected formats of data transfer files. Provide technological expertise and guidance on the best methods for handling laboratory data and other external data. Create and maintain data transfer agreements. Maintain study documentation within project files as appropriate. Act as primary contact and study representative to third party data providers. Effectively communicate transfer requirements and project timelines to various stakeholders. Identify and communicate project risks. Ensure data integrity is maintained by implementing appropriate data controls for masked data. Ensure delivery of timely data transfers and undertake quality reviews and testing activities. Conduct external data reconciliation using available technologies and processes. Raise queries to external data providers and track queries to successful resolution. Provide listings to medical review team. Assess and implement new data review and analysis processes and technologies. Take a lead role in the development of best practices, process improvement, quality control and governance related to all external data matters. Provide training and mentoring to team members in SOPs, software applications, and best practices. Attributes and Skills Expert domain knowledge and experience within clinical research and drug development. Advanced knowledge in >1 EDC systems and laboratory processes. Experience mentoring and training others. Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities. Excellent analytical, communication and problem-solving skills.

This strategic role will support the Business Development team, driving sales lead generation efforts, insights, and analysis to enhance decision-making and contribute to Novotech s continued growth and market leadership Bengaluru based - must be able to attend the Bengaluru office 2 days per week Responsibilities Develop and execute personalized marketing strategies targeting high-value accounts. Align marketing efforts with sales teams to enhance engagement and conversion rates. Utilize data-driven insights to optimize account selection and prioritization Identify, nurture, and qualify potential leads to maintain a healthy lead Management Implement lead scoring models to assess prospect readiness and prioritize outreach Maintain and update marketing databases to ensure accurate and actionable data. Generate detailed reports for Sales Meeting, lead generation, and pipeline health, Executive summary Provide data-driven recommendations to optimize marketing and sales strategies. Track funding trends and investment activities to identify potential opportunities. Experience and Qualifications Degree in Life Science or related field (Pharmacy, Medical, Biology), MBA, Data Science, Business Analytics 5+ years in sales enablement, business development support, inside sales, or sales operations Advanced Microsoft office capabilities and Excel in particular Advanced LinkedIn capabilities. Knowledge of LinkedIn Sales Navigator would be a plus. Excellent oral and written communication and ability to engage, manage, and communicate effectively with stakeholders at all levels of the organization Experience with any data visualization tools Salesforce Analytics/ Tableau / Power BI Experience with CRM & Marketing Automation: Salesforce, Pardot or HubSpot, ZoomInfo Strong analytical skills and proven ability to analyze and interpret internal and external data to generate strategic insights

At least 10-12 years of experience in clinical research across all stages and phases of trials with previous exposure to line or matrix management preferred. Practical experience in handling Trial Master File activities including Paper or electronic - TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Line Management experience is essential. Responsibilities: Act as Line Manager for assigned staff including Team Lead, Centralised Document Management, DMA, SDMA and CDS. Work with the Resourcing Co-ordinator to identify appropriate project assignments for direct and indirect line reports, identify shortfall in resourcing and trigger hiring requests as necessary. Coordinate induction process for all new line reports on commencement of employment. Ensure line reports are aware of and understand company policies and procedures appropriate to their position. Ensure balanced workload and project assignments in line with employees skills and experience. Actively seek feedback and monitor the employee s performance metrics and KPIs, as well as the quality of their work, on an ongoing basis. Provide constructive and developmental feedback to ensure performance standards are maintained. Lead the team in developing all TMF-related processes, tools, training and working practices in collaboration with Senior Clinical Operations Management team. Provides expertise and best practices related to the TMF, including EDs, TMF processes and eTMF systems, and other clinical trial processes. Ensure the document quality requirements are agreed to and met by the study team, according to Completeness, Timeliness and Quality metrics. Responsible for ensuring projects are appropriately resourced to a DMA, SDMA, CDS.

The Payroll Specialist will assist in the management of the Asia Pacific payroll for Novotech with strong analytical skills who is a good communicator and can work independently. Minimum Qualifications & Experiences: Must have at least 2 years payroll experience Bachelor s in Accounting or Business/Commerce degree Responsibilities: Assist with Consolidation of Monthly Movement/Payroll Changes Ensure New Hires documents are accurately completed Update and maintain payroll files Ensure that Payroll files are prepared and sent to the Payroll Provider on a timely basis Resolve payroll problems (e.g. funding, payroll payments, etc.) Answer employee queries concerning payroll Assist in payroll audits Ensure compliance with governmental laws on payroll accounting and taxes

The Site Identification Administrator is a key member of the Clinical Services team involved in the planning and execution of clinical trials by supporting the feasibility of conducting a study Responsibilities Work directly with Clinical Services and Project Management on new business opportunities requiring site outreach. Liaise with the Project Manager to facilitate creation of site outreach questionnaires for new opportunities in CTMS. Ensure the appropriate confidentiality agreements are in place prior to site outreach or prepare the appropriate confidentiality agreement. Ongoing management of site outreach data in CTMS, including data entry and quality control. Perform review of commercial databases and internal tools where required to support the development of candidate site list for new opportunities. Perform data analysis and provide site outreach or other CTMS metrics as requested by Clinical Services Management. Provide regular reports on site outreach data status. Experience and Qualifications Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. Must be able to communicate clearly with excellent verbal and written communication skills, able to prioritise, meet deadlines and able to work well in teams across time-zones. High attention to detail and accuracy is essential. Preferably experienced in working in clinical research, pharmaceutical/biotechnology industry Minimum of 1-2 years experience in data entry.

The Application Analyst (Veeva) supports the day-to-day operations of Clinical Systems/ IT applications (with GxP categorization), ensuring optimal system performance and managing system enhancements. The Application Analyst provides training and technical support to clinical users and contributes to the review and maintenance of processes, tools, and standards. Minimum Qualifications & Experience: Degree in a related field; computer science, information technology and/or information systems. Experience in clinical trial systems supporting the CRO and/or pharmaceutical industry is advantageous. Responsibilities: Provide L1/L2 support for clinical (Veeva Vault Clinical - eTMF, CTMS, SSU, Payments), Vault Study training & Safety) & IT applications with GxP categorization (e.g., LMS, BI application etc) as per company defined SLA s Shall be able to work in different shifts to provide application support for the users (internal and external) spread across different geographical regions (ANZ/Asia/Europe/USA). Manage user access and user roles for clinical systems (Veeva Vault, CTMS, eTMF & Safety) & IT applications with GxP categorization (e.g., LMS, BI application etc) as per applicable Novotech IT SOP s. Responsible for clinical IT systems/applications training to all regions & Users and act as knowledge expert for the systems. Primary liaison with Novotech IT and system/business owner for maintenance changes and upgrades. Perform UAT testing for system upgrades, new release(s) and change management in collaboration with Clinical Systems, IT, and business users. Serve as system administrator and post-production end-user support including helpdesk management.

The Site Identification Administrator is a key member of the Clinical Services team involved in the planning and execution of clinical trials by supporting the feasibility of conducting a study Responsibilities Work directly with Clinical Services and Project Management on new business opportunities requiring site outreach. Liaise with the Project Manager to facilitate creation of site outreach questionnaires for new opportunities in CTMS. Ensure the appropriate confidentiality agreements are in place prior to site outreach or prepare the appropriate confidentiality agreement. Ongoing management of site outreach data in CTMS, including data entry and quality control. Perform review of commercial databases and internal tools where required to support the development of candidate site list for new opportunities. Perform data analysis and provide site outreach or other CTMS metrics as requested by Clinical Services Management. Provide regular reports on site outreach data status. Experience and Qualifications Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. Must be able to communicate clearly with excellent verbal and written communication skills, able to prioritise, meet deadlines and able to work well in teams across time-zones. High attention to detail and accuracy is essential. Preferably experienced in working in clinical research, pharmaceutical/biotechnology industry Minimum of 1-2 years experience in data entry.

We are seeking a Senior Manager, Sales and Marketing Data Scientist to lead data-driven initiatives that optimize sales and marketing performance. This role will apply advanced analytics, machine learning, and predictive modelling to generate insights that drive revenue growth and improve customer engagement. Responsibilities: Data Analysis & Insights Analyze sales and marketing data to identify trends, patterns, and opportunities for revenue growth. Develop predictive models and machine learning algorithms to enhance lead generation, customer segmentation, and sales forecasting. Predictive Modelling & Machine Learning Implement machine learning techniques to optimize targeting, segmentation, and marketing personalization. Forecast client behavior, conversion rates, and sales opportunities using predictive analytics. Campaign & Sales Optimization Measure and optimize the ROI of marketing campaigns through data-driven strategies. Analyze sales funnel performance, identifying areas to accelerate pipeline growth and improve conversion rates. Client & Market Insights Conduct customer segmentation analysis to understand behavior, lifetime value, and churn risks. Provide insights into market trends, competitive positioning, and customer needs to inform strategy. Data Strategy & Automation Develop and manage data pipelines, reporting tools, and automated workflows to improve efficiency. Ensure data accuracy, integrity, and accessibility across CRM, marketing automation, and BI platforms. Collaboration & Leadership Work cross-functionally with sales, marketing, finance, and IT teams to align data strategies with business objectives. Lead, mentor, and develop a team of analysts, providing guidance on best practices, technical skills, and strategic thinking to enhance data-driven decision-making across the organisation Qualifications & Experience: Master s or Phd in Data Science, Statistics, Business Analytics, Computer Science, or a related field. 8+ years of experience in data science, analytics, or a similar role, with a focus on sales and marketing data. Technology expertise in Python, R, or SQL for data analysis and modelling. Strong experience with machine learning frameworks and visualisation tools (Power BI). Proficiency in CRM and marketing automation platforms (e.g., Salesforce and Pardot). Strong business acumen with a deep understanding of sales and marketing metrics, including lead scoring, funnel analysis, and ROI measurement.

The CRM Application Specialist will collaborate with business stakeholders to gather requirements, document processes, create mock-ups, implement CRM solutions with guidance, and generate standard Salesforce reports and dashboards per business request. They will also provide post-live support to ensure smooth CRM operations. Additionally, this role will support the marketing team by leveraging Account Engagement (Pardot) to optimise lead generation and campaign management Responsibilities: CRM Administration & Support:: Act as the primary administrator for the Salesforce CRM system. Work closely with business stakeholders to gather, analyse, and document process and requirements. Design, configure and document CRM solutions to meet business needs, ensuring best practices are followed. Marketing and Sales Team Support: Assist both teams in defining, tracking, and optimising business processes and functions. Utilise Account Engagement (Pardot) to support marketing team on lead generation and nurturing campaigns. Assist the marketing team in automating email campaigns, segmentation, and lead scoring. Post-Live Support & Continuous Improvement: Address post-implementation issues and optimise existing CRM workflows. Provide training and documentation for both teams to ensure CRM adoption. Partner with SMEs to recommend new CRM functionalities and process improvements. Experience and Qualifications: Must have a minimum of 2+ years of experience in Salesforce CRM administration. Must have strong experience with Account Engagement (Pardot) and marketing automation processes. Must have Sales Cloud Consultant certification Ability to gather business requirements and translate them into CRM solutions. Experience in creating documentation, mock-ups, and process workflows. Ideally previous experience from a Managed Service Provider.

About the Role We are seeking a Senior Manager, Sales and Marketing Data Scientist to lead data-driven initiatives that optimize sales and marketing performance. This role will apply advanced analytics, machine learning, and predictive modelling to generate insights that drive revenue growth and improve customer engagement. Responsibilities: Data Analysis & Insights Analyze sales and marketing data to identify trends, patterns, and opportunities for revenue growth. Develop predictive models and machine learning algorithms to enhance lead generation, customer segmentation, and sales forecasting. Predictive Modelling & Machine Learning Implement machine learning techniques to optimize targeting, segmentation, and marketing personalization. Forecast client behavior, conversion rates, and sales opportunities using predictive analytics. Campaign & Sales Optimization Measure and optimize the ROI of marketing campaigns through data-driven strategies. Analyze sales funnel performance, identifying areas to accelerate pipeline growth and improve conversion rates. Client & Market Insights Conduct customer segmentation analysis to understand behavior, lifetime value, and churn risks. Provide insights into market trends, competitive positioning, and customer needs to inform strategy. Data Strategy & Automation Develop and manage data pipelines, reporting tools, and automated workflows to improve efficiency. Ensure data accuracy, integrity, and accessibility across CRM, marketing automation, and BI platforms. Collaboration & Leadership Work cross-functionally with sales, marketing, finance, and IT teams to align data strategies with business objectives. Lead, mentor, and develop a team of analysts, providing guidance on best practices, technical skills, and strategic thinking to enhance data-driven decision-making across the organisation Qualifications & Experience: Master s or Phd in Data Science, Statistics, Business Analytics, Computer Science, or a related field. 8+ years of experience in data science, analytics, or a similar role, with a focus on sales and marketing data. Technology expertise in Python, R, or SQL for data analysis and modelling. Strong experience with machine learning frameworks and visualisation tools (Power BI). Proficiency in CRM and marketing automation platforms (e.g., Salesforce and Pardot). Strong business acumen with a deep understanding of sales and marketing metrics, including lead scoring, funnel analysis, and ROI measurement

The CRM Application Specialist will collaborate with business stakeholders to gather requirements, document processes, create mock-ups, implement CRM solutions with guidance, and generate standard Salesforce reports and dashboards per business request. They will also provide post-live support to ensure smooth CRM operations. Additionally, this role will support the marketing team by leveraging Account Engagement (Pardot) to optimise lead generation and campaign management Responsibilities: CRM Administration & Support:: Act as the primary administrator for the Salesforce CRM system. Work closely with business stakeholders to gather, analyse, and document process and requirements. Design, configure and document CRM solutions to meet business needs, ensuring best practices are followed. Marketing and Sales Team Support: Assist both teams in defining, tracking, and optimising business processes and functions. Utilise Account Engagement (Pardot) to support marketing team on lead generation and nurturing campaigns. Assist the marketing team in automating email campaigns, segmentation, and lead scoring. Post-Live Support & Continuous Improvement: Address post-implementation issues and optimise existing CRM workflows. Provide training and documentation for both teams to ensure CRM adoption. Partner with SMEs to recommend new CRM functionalities and process improvements. Experience and Qualifications: Must have a minimum of 2+ years of experience in Salesforce CRM administration. Must have strong experience with Account Engagement (Pardot) and marketing automation processes. Must have Sales Cloud Consultant certification Ability to gather business requirements and translate them into CRM solutions. Experience in creating documentation, mock-ups, and process workflows. Ideally previous experience from a Managed Service Provider.

The Proposal Budget and Contract Specialist I is responsible for the development and preparation of proposals, budgets and contracts for new business. The PBC Specialist will be accountable for generating high quality and timely proposals, budgets and contracts. PBC Specialist work closely with the Business Development team and Projects Managers to ensure high quality documents are delivered according to client expected timelines. Responsibilities: Collaborate with BDA/M and Client Operations to develop the required documents to support the development of new and repeat business opportunities. On all assigned opportunities, ensure a high level of understanding of the requirements, scope and client expectations, undertaking a detailed review of the RFP, proposed project outline and any other available resources. Prepare high-quality proposal materials. Collate required content and finalise proposal; responsible for substantive editing, drafting and formatting to ensure proposals accurate reflect customers requirements and are consistent with Novotech branding guidelines. Research, compile and present statistics, experience tables and company information for RFP and RFIs. Prepare budgets for new opportunities and change orders based on sponsor requirements in the Novotech pricing tool within the required timeframe. Collaborate with BDA/M, Client Operations and Project Management to revise and negotiate budgets with sponsors as required. Prepare other budget documentation, including mapping to client grids where required. Accurately prepare simple-medium complexity client budgets mapped from the Novotech pricing tool. Liaise with vendors and external parties for quotes and vendor capabilities where required for incorporation into budgets and proposals. Lead collation of input from other Novotech departments where required to address RFP and sponsor questions. Prepare sponsor contracts and facilitate legal department review and execution in accordance with agreed timelines and guidance. Work closely with the Clinical Operations team to facilitate contract development, negotiation and execution for pre and post-award contracts. Collaborate with BDA/M and Client Operations to develop materials for Bid Defense meetings. Attend and contribute to Bid Defense preparation meetings. Participate in BD handover meetings to Novotech Operational team where requested. Maintain and update required systems including SalesForce and SharePoint in a timely manner. Qualification: Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. At least three years experience within the pharmaceutical industry in a similar role preparing proposals, budgets and/or contracts. At least one years experience preparing budgets, contracts and proposals in a CRO environment or demonstrated exceptional capabilities in proposal, contract and budget development within Novotech. Previous experience working directly with clients will be highly regarded. Must be able to communicate clearly, able to priorities and meet deadlines. Must have advanced Microsoft office capabilities, specifically Excel, Word and PowerPoint.

The Proposal Budget and Contract Specialist I is responsible for the development and preparation of proposals, budgets and contracts for new business. The PBC Specialist will be accountable for generating high quality and timely proposals, budgets and contracts. PBC Specialist work closely with the Business Development team and Projects Managers to ensure high quality documents are delivered according to client expected timelines. Responsibilities: Collaborate with BDA/M and Client Operations to develop the required documents to support the development of new and repeat business opportunities. On all assigned opportunities, ensure a high level of understanding of the requirements, scope and client expectations, undertaking a detailed review of the RFP, proposed project outline and any other available resources. Prepare high-quality proposal materials. Collate required content and finalise proposal; responsible for substantive editing, drafting and formatting to ensure proposals accurate reflect customers requirements and are consistent with Novotech branding guidelines. Research, compile and present statistics, experience tables and company information for RFP and RFIs. Prepare budgets for new opportunities and change orders based on sponsor requirements in the Novotech pricing tool within the required timeframe. Collaborate with BDA/M, Client Operations and Project Management to revise and negotiate budgets with sponsors as required. Prepare other budget documentation, including mapping to client grids where required. Accurately prepare simple-medium complexity client budgets mapped from the Novotech pricing tool. Liaise with vendors and external parties for quotes and vendor capabilities where required for incorporation into budgets and proposals. Lead collation of input from other Novotech departments where required to address RFP and sponsor questions. Prepare sponsor contracts and facilitate legal department review and execution in accordance with agreed timelines and guidance. Work closely with the Clinical Operations team to facilitate contract development, negotiation and execution for pre and post-award contracts. Collaborate with BDA/M and Client Operations to develop materials for Bid Defense meetings. Attend and contribute to Bid Defense preparation meetings. Participate in BD handover meetings to Novotech Operational team where requested. Maintain and update required systems including SalesForce and SharePoint in a timely manner. Qualification: Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. At least three years experience within the pharmaceutical industry in a similar role preparing proposals, budgets and/or contracts. At least one years experience preparing budgets, contracts and proposals in a CRO environment or demonstrated exceptional capabilities in proposal, contract and budget development within Novotech. Previous experience working directly with clients will be highly regarded. Must be able to communicate clearly, able to priorities and meet deadlines. Must have advanced Microsoft office capabilities, specifically Excel, Word and PowerPoint.

The Proposals Budget and Contracts Associate is primarily responsible for all the development and preparation of proposals, budgets and contracts for new business. The PBC Associate will be accountable for generating high quality and timely proposals, budgets and contracts. PBC Associates work closely with the Business Development team and Projects Managers to ensure high quality documents are delivered according to client expected timelines. Minimum Qualifications & Experience: Minimum bachelor s degree in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. At least three years experience within the pharmaceutical industry. Previous experience working directly with clients will be highly regarded. Must be able to communicate clearly, able to prioritize and meet deadlines. Must have advanced Microsoft office capabilities, specifically Excel, Word and PowerPoint. Responsibilities: Develop proposal: Prepare high quality proposals and presentation materials. Collate required content and finalize proposal (involves substantive editing & drafting to ensure readability, consistency in formatting to ensure that proposals accurately reflect customers requirements and is consistent with Novotech branding guidelines) Ensure proposal templates remain relevant and compliant and of a high visual standard. Research, compile and present statistics and company information. Develop budget: Prepare budget for projects based on client information provided to schedule timeframe. Prepare other budgets elements (client mapping etc.) as required to timeframes. Liaise with vendors to obtain quotations. Develop Contracts: Prepare all new client contracts and execute in accordance with agreed timeframes and guidance. Obtain appropriate format of Budget for inclusion in contracts. Contracts executed in accordance with Novotech Contract Review SOP. Follow Start Up Work Authorization process to activate project for handover to Operations team. Contact vendors and obtain quotes: Contact vendors for quotes based on protocol and vendor lists. Engage Operation team as required for assistance. Other Responsibilities: Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communication with external parties is presented in a positive and professional manner. Attend calls with internal teams and clients in development of opportunity documents. Maintain and update opportunity status within Salesforce. Maintain contracts records in Salesforce and SharePoint.

At least 12 months experience in a clinical research organization or equivalent. Practical experience in handling Trial Master File activities including Paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. DMA will review each document as received for quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. Runs monthly reports to ensure accuracy of the files by performing file reviews. Prepares the TMF for delivery at study closeout. Reviews and prepares the TMF for audits and TMF reviews; Provide support to TMF Operations during audits and/or regulatory inspections. Resolves any internal quality control findings and audit findings. Runs and maintains department reports. Creates checklists and daily quality control schedules. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Responsibilities Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. DMA will review each document as received for quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. Runs monthly reports to ensure accuracy of the files by performing file reviews. Prepares the TMF for delivery at study closeout. Reviews and prepares the TMF for audits and TMF reviews; Provide support to TMF Operations during audits and/or regulatory inspections. Resolves any internal quality control findings and audit findings. Runs and maintains department reports. Creates checklists and daily quality control schedules. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

At least 12 months experience in a clinical research organization or equivalent. Practical experience in handling Trial Master File activities including Paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. DMA will review each document as received for quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. Runs monthly reports to ensure accuracy of the files by performing file reviews. Prepares the TMF for delivery at study closeout. Reviews and prepares the TMF for audits and TMF reviews; Provide support to TMF Operations during audits and/or regulatory inspections. Resolves any internal quality control findings and audit findings. Runs and maintains department reports. Creates checklists and daily quality control schedules. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: At least 12 months experience in a clinical research organization or equivalent. Practical experience in handling Trial Master File activities including Paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. DMA will review each document as received for quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. Runs monthly reports to ensure accuracy of the files by performing file reviews. Prepares the TMF for delivery at study closeout. Reviews and prepares the TMF for audits and TMF reviews; Provide support to TMF Operations during audits and/or regulatory inspections. Resolves any internal quality control findings and audit findings. Runs and maintains department reports. Creates checklists and daily quality control schedules. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.