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Reference #: JR5620 SUMMARY/JOB PURPOSE:

The Associate Trial Master File Director exhibits advanced experience with Project Management, is accountable for the oversight of projects for TMF Management, and ensures that projects are assigned realistic timelines with appropriate resources. This role oversees TMF technology and systems and works directly with the staff responsible for processing, assessing quality, and archiving of clinical trial documents from both external and internal sources, while fostering a culture of continuous improvement. This role requires a Veeva expert with cross vault applications, a technical expert, specifically eTMF, that drives the successful development and implementation of enhanced features, technical improvements, and system releases for the Veeva eTMF.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

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.

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

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 nineyears of related experience; or, Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

10+ years of experience working in a pharmaceutical or other highly regulated corporate environment, including 5+ ear 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.

Knowledge/Skills:

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.

WORKING CONDITIONS:

Occasional travel may be required. #LI-JD1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets.  The base pay range for this positionis $143,000 - $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.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.  Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.  Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to th