TMF Services Lead / Senior Services TMF Lead AstraZenecaLocation: Gaithersburg, Maryland, United States
Job reference: R-014760
Posted date: Oct. 03, 2017
If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a TMF Services Lead / Senior Services Lead in Gaithersburg, MD you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
Develop and direct TMF Services (e.g., filing, index management, certified scanning, divestment and acquisitions, inspection preparation, metrics management, quality control) including workload management to ensure that Trial Master File (TMF) are managed and archived in accordance with relevant Standard Operating Procedures, ICH guidelines, GCP regulatory requirements and other regulations as may be appropriate. This includes ensuring TMF Services are aligned to services provided by AZ TMF Central Group and the activities of internal staff, cross functional study teams and TMF vendors. This involves oversight for, and hands-on contributions to, the development of SOPs, Guidelines, Work Instructions and other tools as appropriate. This includes evaluating and implementing technology that supports TMF Services. Actively monitor and ensure that effective processes and associated technologies are in place to support all TMF Services.
Defines and manages overall TMF Services via a combination of internal resources and third party vendors. Develops and implements standard operating procedures for TMF Services. Evaluates and implements technology that supports TMF Services. Responsible for the management, operations and procedures for archiving in accordance with GCP regulations. Implements record retention policies for clinical documentation in accordance with Corporate, Legal, and other applicable policies and/or regulations. Develops and implements effective TMF metrics to drive TMF compliance and quality and delivery of TMF Services. Actively engages with Document Specialists, clinical study teams and management. Identifies opportunities for continuous process improvement and recommends potential solutions. Acts as the single-point-of-contact for all vendor inquiries and for all TMF vendor management activities. Leads the resolution of issues and identifies and implements remediation activities with the vendor. Manages and provides direction to external TMF third party vendor and ensures that all documentation activities are conducted in compliance with GCP and other regulatory requirements and relevant SOPs, and that documents meet appropriate quality standards. Manages TMF during internal audits and inspections and assists in the preparation. Functions as subject matter expert on local and international GCPs related to the TMF. Reviews TMF quality health checks and/or audits to identify trends to ensure documentation meets quality and relevant regulatory requirements. May also contribute to future TMF strategies (e.g., electronic archiving). Develops, assesses, and/or provides training for Document Specialists and/or study teams on TMF processes, work instructions, and templates, as needed, in order to ensure adequate compliance. Undertake other related duties as may be assigned.
Education: BA or BS degree (or higher) in a scientific/technical discipline or equivalent local degree/experience.
Minimum 5 years of experience (8 years for the senior role) in pharmaceutical industry or clinical-related discipline including 3 years of experience (5 years for the senior role) in operations management or documentation/records management.
Proven experience developing, implementing and improving operational processes on a global, cross functional scale. Proven experience using metrics to drive compliance and improve processes. Experience in preparing for and being part of GCP compliance audits/assessments/document reviews is required. Excellent knowledge of excel or other tools for metrics collection. Experience with matrix management. Demonstrable knowledge of drug development processes.
Minimum experience includes TMF experience, operations management experience, and process management experience. Individual must have experience with records and information management and archiving experience as well as developing, implementing and using operational metrics. Previous experience with use of or oversight of an eTMF system is a must. Strong knowledge of global regulatory and legal requirements pertaining to the TMF. Experience with the DIA TMF Reference Model.
Must be able to function under minimal supervision, and function as a delegate to the Director, TMF as requested. Matrix management of internal team of Document Specialist and/or contractor(s).
Additional Skills required are strong people management and communication skills, strong use of technology, being able to multitask in fast-paced environment, able to utilize and encourage innovative approaches, being able to relate well to all levels of staff, approachable and builds constructive and collaborative relationships, Uses tact and diplomacy, able to make decisions in a timely manner, sometimes with incomplete information, and results-oriented.
Prior involvement in regulatory inspections is desirable.
Use of lean/six sigma is desirable.
Working knowledge of clinical trial design, execution and clinical operations/development highly desirable.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.