Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
Post : Associate Trial Master File Director
Job Description
• Delivers Project Management principles within the team to track, monitors and delivers on all TMF-related work.
• Clearly and proactively anticipates, identifies, tracks, communicates, and proposes solutions for discrepancies in priorities and plans, prioritize complex and multiple/conflicting responsibilities and/or issues.
• Manages the Veeva roadmap by working closely with internal stakeholders and Veeva on the integration of other Veeva Platforms: RIMs, CTMS, QMS with eTMF to ensure it meets business needs.
• Designs and implements RPA technology within TMF Management to streamline TMF processes and improving efficiencies utlizing Bot technology.
• Ensures internal audits and Health Authority inspections are set-up appropriately in Veeva eTMF with appropriate access when needed.
• Represents TMF Management for all Veeva releases and enhancements.
• Deploys and maintains Veeva Milestone Master Sets and Expected Document Lists in eTMF.
• Performs analysis of the monthly Quality Metrics and KPIs to address any gaps or compliance risks in TMF and communicate results out to the organization.
• Effectively manages the CRO relationship to ensure the CRO responds to quality issues and other high-quality deliverables within timelines.
• Drives the development of TMF-related documentation: SOPs, WIs, Job Aids and other tools (reference materials, flowcharts, guidances, etc.).
• Develops Zone Owners, who will represent the Functional Areas based on the TMF Reference Model, to help increase efficiencies and eTMF user base.
• Ensures reports and dashboards are developed and available for teams in Veeva eTMF.
• Exhibits a working knowledge of regulatory standards (e.g., ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management and records management (e.g., TMF reference model).
• Provides oversight to TMF Management team in developing eTMF educational sessions for the user community.
• Helps develop a TMF Governance structure that will support key decisions and actions around eTMF for the company.
• Ensures TMF compliance with industry standards and regulations with the goal of Inspection Ready for all studies.
• Oversees clinical trial document quality control activities to ensure that study TMFs are inspection ready.
• Supports overall goals and objectives of the function and company.
• Leads additional initiatives for TMF, Clinical Compliance & Risk Management or Development Operations as needed.
• Provides mentorship, leadership and guidance to junior level staff or contracy employees.
• Contributes to the design, development, and deployment of eTMF in a collaborative teamwork setting.
Candidate Profile
• BS/BA degree in related discipline and a minimum of eleven years of related experience; or,
• MS/MA degree in related discipline and a minimum of nine years of related experience; or,
• Equivalent combination of education and experience.
• 10+ years of experience working in a pharmaceutical or other highly regulated corporate environment, including 5+ year in experience with electronic document management systems, with progressive experience managing active, inactive, and archived records, analyzing business processes, and developing and implementing Records Management policy and procedures.
• Broad understanding of business processes in a wide variety of functional areas within a large, international pharmaceutical company, and the ability to translate the records management needs of those business processes into clear and concise terminology, logical and hierarchical arrangements of records types and series, and clear and effective procedures for filing and managing both records and non-records.
• Expert knowledge of TMF for set-up and maintenance.
• Knowledge of eTMF systems are desirable but experience in Veeva Vault Clinical is required.
• Good communication skills both oral and written are a must. Applies strong analytical and business communication skills.
• Excellent attention to detail, strong critical thinking, and problem solving.
• Excellent organizational, time management, and project management skills.
• Applies technical standards, principles, theories, concepts, and techniques.
• Demonstrates experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.
• Self-motivation, eagerness to grow professionally and commitment to self-development.
Job Complexity
• Applies technical expertise in project management and contributes to the development of new concepts, techniques, and standards.
• Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
• Builds productive internal and external working relationships.
• Uses professional concepts and company’s policies and procedures to solve a variety of routine problems.
• Veeva expert for cross vault applications.
The base pay range for this position is USD 143,000 - USD 203,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Job Location : King of Prussia, PA
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