Premier Research is looking for a Associate Director, TMF Process, Systems and Training to join our Pharmacovigilance and Records Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What You ll Be Doing: The Associate Director, TMF Process, Systems and Training within Global Records Management (GRM) leads or assists with the department s TMF processes, systems and training improvement efforts in conjunction with Departmental Leadership. This includes the management of GRM staff and responsibility for TMF processes and systems used in the management of Trial Master Files (TMFs) globally. The position is responsible for supporting and/or providing strategic leadership and resolving complex issues related to Premier s TMF processes, systems and related training in creative and effective ways within the department. Establishing plans and objectives in partnership with fellow GRM management and other leaders within the Company to optimize effectiveness of Premier s TMF management services. Supporting and/or providing strategy and management for department resources, records management procedures and systems while ensuring adherence to Premier s standards and all applicable regulations and guidelines. A key responsibility being to promote set-up, management and delivery of high quality and inspection ready TMFs being managed by Premier. Recognizing, developing and executing TMF process, systems and training strategies to ensure that all assigned TMF management activities performed by Premier are conducted efficiently and are following all applicable regulations and company policies and procedures Manages, coaches and develops a highly skilled and motivated team of records management staff. Overseeing all TMF process and systems training activities to ensure compliance with ICH-GCP, relevant SOPs, and all applicable regulatory requirements and quality standards. Leading functional groups to identify TMF process, systems and training issues and implement necessary remediation activities. Serving as a point of contact on TMF processes, systems and training to Premier, Sponsors, third parties, auditors and inspectors. Providing line management of department management and staff as assigned. Maintains expert level knowledge of all applicable regulations, guidelines, policies, and industry practices for TMF Management. Other activities as designated by Department Leadership. What we are looking for: Minimum of an undergraduate degree, or its international equivalent, from an accredited institution majoring in records and information management, library science, clinical, science or health related field - or - an equivalent level of clinical trials records management process, systems and training experience. Advanced TMF management process, systems and training experience in the CRO, pharmaceutical or medical device industry: 15+ years is required for Associate Director. Advanced systems training experience preferably with Trial Interactive, Veeva Vault and/or Wingspan is required. Advanced knowledge in industry trends related to TMF management is required. 5+ years line management experience providing coaching, guidance and feedback to junior management and/or staff. 3 + years demonstrated departmental leadership skills. Advanced knowledge of ICH-GCP guidelines and global regulations as they pertain to TMF management is required. Excellent interpersonal skills with the ability to communicate effectively verbally and in writing. Demonstrated flexibility and adaptability to rapidly changing requirements. Ability to multitask and work effectively in a fast-paced CRO environment. Fluent verbal and written English communication and negotiation skills. Excellent organizational and time-management skills. Customer service focused. Accountable, dependable and with strong commitment to the department and Company. Maintains a positive, results orientated work environment. Ability to consistently exercise independent judgment. Ability to solve problems of diverse scope and complexity within a cross-department work environment.

Coordinates and facilitates all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations; Supports Principal Investigator (PI) and site study team assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators, Reviews the site processes, identifies gaps and supports roll-out of site processes. The following key functions are required routinely: Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/Investigator Maintaining clinical trial-related documents at site including Trial Master File. Preparing for, facilitating and assisting at site initiation, monitoring and close-out visits protocol-prescribed and other necessary patient-visits, QA visits, sponsor visits and Inspections. Reporting site-performance metrics at pre-determined frequency. Coordinating submissions to ethics committee of protocol, adverse events and periodic study reports for review and ensuring that all documentation to and from ethics committee is appropriately maintained. Assisting in scheduling patient investigations and assessments per instructions of Principal Investigator Ensuring timely availability of IP and Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary; also maintaining IP accountability and accurate record of all clinical trial supplies including lab kits; dispensing of IP to subjects per the protocol under the supervision of the PI Assuring that all work at site prescribed by the approved protocol, the contract and the EC is performed in a timely and comprehensive manner Organizing and coordinating laboratory sample pick-ups and reporting Transcribing source documents if required under the supervision of the PI or designated person and ensuring that they are reviewed and signed off by the responsible person. Assisting in timely resolution of data queries Coordinating and supporting timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening and enrolment Maintaining regular contact with site monitor regarding patient enrolment, visit scheduling, dosing/dispensing Facilitating cordial and timely communication between investigator and sponsor/CRO - Supporting patient-awareness, training or other events at site or in the neighborhood Supporting data collection activity at site including but not limited to feasibilities, epidemiological data To create the database of potential patients that can be enrolled into the study as per the protocol To identify any challenges and find out mitigation plan in advance with the support of LM, TSM PI Responsible to complete all mandated training and ongoing training modules and SOPs Responsible for notifying Sponsor / CRO representatives of external audits/ inspections by the sponsor and regulatory authorities respectively. Collaborates with PI to respond to any audit findings and implement approved recommendations. Escalate systemic non-compliance and/or misconduct to his /her manager for appropriate follow-up. Directs all feasibilities coming to the site to feasibility team at CS. What we are looking for: A Bachelor s or Master s degree in clinical, biological or mathematical sciences or related fields, or a medical or dental degree or a nursing qualification; Exceptions to this would require a minimum of 4 years of experience of working at clinical research sites. Good oral and written communication skills in English and at least one local Indian language Excellent interpersonal skills Good coordination and organizational skills and also problem-solving and analytical skills Attention to detail and documentation and conscious of the importance of time and data accuracy in the clinical trial context Conscious of ethical and scientific requirements and of patient-safety and patient-rights in the clinical trial context Familiarity with computer usage and office communication tools