BASIC PURPOSE:Create and test SAS code used for standard and non-standard data file creation; Review Clario standard and non-standard data specifications. ESSENTIAL DUTIES AND RESPONSIBILITIES: Attend client meetings as appropriate to understand data collection requirements. Review standard CLARIO and non-standard data specifications and interact with the Data Manager (DM) to finalize specifications. Develop programs to create Clario standard and non-standard data files. Participate in the validation of encoding programs which generates CLARIO standard and non-standard data files. Process data extracts, review encoding requests daily to run encoding programs and participate in study archival. Performing ad-hoc programming activities utilizing raw data based on internal and external requests for: a. Esoteric quality control checks requested by QC. b. Data resolution/Mining. c. Other client requirements. Get exposed to 5 modalities. Review User Requirements and create and/or review Functional and Technical Specifications. Work with data management in providing programming support for DM activities including data review. OTHER DUTIES AND RESPONSIBILITIES: Assist with orientation and training of personnel as determined by management. Contribute to process development. Review and development of SOPs and associated documents related to Clinical Data Programming activities. Complete administrative tasks as needed within Clinical Data Programming. The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. The Company reserves the right to amend or change this job description to meet the needs of the Company. This job description and any attachments do not constitute or represent a contract. QUALIFICATIONS AND SKILLS NEEDED: (Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.) Education : BS/BA Degree in Life Sciences or related field preferred or BS/BA Degree in computer sciences or related field Experience : SAS BASE certified Minimum three years of experience with ADVANCED SAS products and procedures and/or one year experience in database design and data structures. Good understanding of the pharmaceutical drug development process. Strong organization, analytical and communication skills Detail-oriented Experience in implementing CDISC SDTM and Define standards. Including EG, CO, DM, RE, VS, SUPP CDISC SDTM domains. Experience with Windows and Microsoft Office products preferred. Strong written and verbal communication skills. Fluency in English (spoken and written).

BASIC PURPOSE:Create and test SAS code used for standard and non-standard data file creation; Review Clario standard and non-standard data specifications. ESSENTIAL DUTIES AND RESPONSIBILITIES: Attend client meetings as appropriate to understand data collection requirements. Review standard CLARIO and non-standard data specifications and interact with the Data Manager (DM) to finalize specifications. Develop programs to create Clario standard and non-standard data files. Participate in the validation of encoding programs which generates CLARIO standard and non-standard data files. Process data extracts, review encoding requests daily to run encoding programs and participate in study archival. Performing ad-hoc programming activities utilizing raw data based on internal and external requests for: a. Esoteric quality control checks requested by QC. b. Data resolution/Mining. c. Other client requirements. Get exposed to 5 modalities. Review User Requirements and create and/or review Functional and Technical Specifications. Work with data management in providing programming support for DM activities including data review. OTHER DUTIES AND RESPONSIBILITIES: Assist with orientation and training of personnel as determined by management. Contribute to process development. Review and development of SOPs and associated documents related to Clinical Data Programming activities. Complete administrative tasks as needed within Clinical Data Programming. The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. The Company reserves the right to amend or change this job description to meet the needs of the Company. This job description and any attachments do not constitute or represent a contract. QUALIFICATIONS AND SKILLS NEEDED: (Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.) Education : BS/BA Degree in Life Sciences or related field preferred or BS/BA Degree in computer sciences or related field Experience : SAS BASE certified Minimum three years of experience with ADVANCED SAS products and procedures and/or one year experience in database design and data structures. Good understanding of the pharmaceutical drug development process. Strong organization, analytical and communication skills Detail-oriented Experience in implementing CDISC SDTM and Define standards. Including EG, CO, DM, RE, VS, SUPP CDISC SDTM domains. Experience with Windows and Microsoft Office products preferred. Strong written and verbal communication skills. Fluency in English (spoken and written).

Are you passionate about delivering high-quality solutions design consultation to pharmaceutical and biotechnology clients Clario is looking for a dedicated Team Lead to join our eCOA Solutions Design team in India. In this role, you will work closely with project teams and interface with clients and Clario solutions delivery leadership to ensure clinical protocols are efficiently and accurately mapped to software solutions within project scope. As a Team Lead, you will serve as an escalation point for study-related issues, assist in project allocations, utilization, and productivity, and take on supervisory responsibilities. If you thrive in a collaborative environment and are committed to excellence, we want to hear from you! What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Support the performance review process by providing applicable feedback to Solutions Design management, Conducts one on one bi-weekly meetings with Solutions Design Analyst team to discuss project status, issues, and issue resolution strategies Formally summarizes and responds to audit observations, and ensure implementation of any Corrective and Preventative Actions Functions as a subject matter expert to advise on internal devices and system functionalities, acting as a resource and mentor for other SD team members Functions as a subject matter expert to advise internal and external clients on design processes, specification design, and requirement gathering best practices Serves as escalation point on Study Related Issues Coordinates the overall Solutions Design Process ensuring that clinical protocols are appropriately mapped to software solutions efficiently, accurately and within project scope Creates and maintains specifications for study-specific implementations of Clario products and services using a Documentation Management System Ensures consistency between trial data capture, data delivery and database structures to meet client requirements Is responsible for the overall management of the Design Process including communication of design requirements internally and externally with the Customer. This includes participation in internal and external design milestone meetings Collaborates with Clinical Systems Translation Licensing (CSTL) to confirm correct versions of copyrighted questionnaires are implemented Supports Solutions Validation/Quality Control testing by addressing any defects associated with the design in a timely manner Collaborates with other departments to investigate study issues found beyond the start-up phase of the study Collaborates with DM to ensure that the software solution captures the necessary data points for data extraction and that the Data Management Plan supports the software solution Assists in project scoping and change control processes including revision management Provides Estimates on new product initiatives, Assists in the evaluation of new product features Provides feedback with regard to product functionality and shares with Product Development group. Collaborates with RD, Design, Innovation (design custom controls) Contributes to developing new core product offerings, and advising on improving existing devices Provides input to interdepartmental process improvement initiatives Coordinates the training of new team members on all aspects of the design process and standard practices and ensures these practices are consistently implemented across the group Performs Process Evaluation and leads internal projects to develop best practices Assists and advises on process Documentation, SOP, and Work Instructions related to departmental deliverables Tracks and evaluates trends in issues, CAPAs and project health to advise training topics Assists/Supports in the training of the SD staff on standard practices and ensures these practices are consistently implemented across the group Supports Solutions Design Delegate in audit preparation by researching project specific or process standards information as needed to evaluate or respond to audit findings Manages Solutions Design project allocations and resource assignments, utilization and productivity Assists management in monitoring and ensuring that design milestones are met on time across the department Reviews and analyzes proposals and protocols as needed, oversee and approve new study quotations Assists in the coordination of project allocations, utilization, productivity, and approval of timecards Completes activities in the Training Management System in a timely manner Tracks time for billable study related and non billable tasks in a timely manner Tracks SDA milestone start and completion dates using the Clario project scheduling tool Represents Solutions Design in sales inquiries describing the design function and best practices Collaborates with senior leadership counterparts from other Departments Serves as additional delegate representing Solutions Design in client audits to describe process flows, standards and best practices Assists management conduct interviews for hiring SDAs Leads internal SD team meetings as needed Participates in bid defense preparations when required May perform the role of Squad Leader of a cross functional team within Solutions Delivery made up of 12-15 employees working on assigned studies. Coordinates the solutions development process among team members ensuring that customer commitments, timelines and quality standards are met Collaborates with Sales and Science teams to act as a Subject Matter Expert on Devices, Device Functionality, Study Designs and Modalities to support new study quotations where appropriate Performs other duties as directed by Solutions Design Management What were looking for BS, BA or equivalent (in science/health care-related field a plus) Previous experience working with with eCOA / ePRO, IRT/RTSM, eConsent, or other eClinical / Clinical / Healthcare technology solutions is highly desirable Minimum of 8 years of total relevant experience Minimum of 5 years of Clinical Indication Specific experience Minimum of 3 years of Sponsor Specific Standards experience Demonstrated ability to mentor and lead a team Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models Demonstrated experience in interpretation of client requirements to prepare and document design specifications Proven experience in client relations and interactions with clients at all levels Familiarity with FDA regulatory processes, clinical research processes Self directed - comfortable working in a fast-paced environment Ability to manage multiple project tasks and deliverables Proven problem-solving skills and attention to detail Excellent presentation, communication (written and oral) and negotiation skills At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

Job Description: The Validation/Quality Assurance Specialist is responsible for ensuring the quality and reliability of client applications. This includes analysing user requirements, defining test plans, creating and executing test scripts, and documenting results. The role involves interfacing with clients, reviewing specifications, and collaborating with a team to deliver high-quality application releases. The specialist will also assist in troubleshooting application failures and creating automated test scripts. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Flexible hybrid working policy What you ll be doing Validation/Quality Assurance of client applications, including analyzing user requirements, defining test plans, test scripts, and related validation and QA documentation, and ensuring quality application development by: Interfacing with client sponsors, business managers, application users, and shared services Reviewing, understanding, and suggesting improvements to user requirements and functional specifications Planning a validation approach for small applications or modules of larger applications Working within a team to ensure high quality application releases Building validation (test) scripts for single functions and scenarios in alignment with internal and/or client processes Assisting in the creation of test script suites for modules and full applications, ensuring complete coverage of new code for application releases Executing and documenting the results of validation scripts for application releases, including both new and regression scripts Creating automated test scripts Ensuring execution of automated test scripts as appropriate in support of application releases Assisting in the troubleshooting of application failures Verifying work of other validation services team members to ensure quality deliverables Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) Assisting in establishing and enforcing departmental standards Participating in the modification of company SOPs Understanding and adhering to client SOPs Helping others to accomplish results Performing other duties as assigned Suggesting and implementing improvements to work processes to better meet project schedule and budget, reduce project risk, or improve the final product Attending and participating in applicable company sponsored and client-required training Self-directed learning of applicable tools, processes, and industry standards What we look for Bachelor s degree in computer science, engineering or related field, or suitable related job experience 2+ years experience in software validation or quality assurance, preferably within the pharmaceutical industry and/or within supply chain Proven ability to validate software applications using standardized methodologies Proven ability to analyze complex issues Working knowledge of SQL Competency with MS Office Working knowledge of test management tools Working knowledge of automated testing tools Working knowledge of Software Development Life Cycles Ability to work in a team environment Strong problem-solving and organizational skills High attention to detail Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames Excellent oral and written communication skills At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

Are you seeking a purposeful and rewarding Project Management career opportunity within a Data Management focused team Our Medical Imaging Data Delivery team is growing in India, and with big ambitions and a clear vision for the future, now is the time to join Clario as a Project Manager, Data Delivery. What we offer Competitive compensation + shift allowances Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Performs project scheduling and communication needs by: Reviewing Data Delivery requests and collaborating with key stakeholders to schedule study delivery activities. Coordinating project expectations with key stakeholders for study delivery timelines. Tracking, managing, and reporting of the Data Delivery progress using delivery management platform/s. Providing Data Delivery updates to key lead representative(s). Communicating timely, appropriate Data Delivery information to project teams, team leads and company representative(s). Performs Data Delivery management by: Identifying critical Data Delivery success factors for tracking, analysis, and reporting. Collaborating with department leaders for appropriate training of those involved with the Data Delivery towards excellence in successful and timely completion of deliverables. Understanding SOPs and working closely with QA for clarification and documentation of deviations. Training and maintaining Data Delivery team knowledge and applications of SOPs. Communicating all clarifications/revisions to project team. Coordinating data collection with internal and external teams for metrics and reporting. Provides cross functional team support by: Leading by example with professional and collaborative conduct Developing and delivering project team training Maintain quality service and departmental standards by: Reading, understanding, and adhering to organizational standard operating procedures (SOPs) Contribute to team effort by: Working with internal staff to resolve issues. Helping others to achieve results. Performing other duties as assigned Maintain technical and industry knowledge by: Attending and participating in applicable company-sponsored training Maintaining a strong understanding of industry trends and applicable technology What we look for Bachelor s degree preferred. Equivalent work experience of 3+ years will be considered. Experience identifying and troubleshooting software problems. Experience working with computer software including the MS Office suite and Jira. Ability to work in group setting and independently. Ability to adjust to changing priorities. Ability to organize and prioritize assigned tasks to meet established schedules, timelines, or deadlines. Problem solving abilities. Strong interpersonal and communication skills (both verbal and written) Excellent attention to detail and meticulous work Ability to maintain a professional and positive attitude.