Associate Director, Clinical Documentation and Trial Master File

About the Role >>> Associate Director, Clinical Documentation and Trial Master File 

The Associate Director, Trial Master File oversees and manages the TMF, eTMF technology and systems, and works directly with internal and external stakeholders responsible for processing, assessing, and archiving clinical trial documents. The successful candidate is accountable for the oversight of projects associated with TMF Management and ensures that projects are assigned realistic timelines with appropriate resources, driven by strong Project Management principles and while fostering a culture of continuous improvement. This role requires a Veeva expert with cross-vault application experience and technical experience, specifically Clinical Vault eTMF, who will drive successful development and/or implementation of enhanced features, technical improvements, and system releases for the eTMF. 

This is a fantastic leadership opportunity for a motivated individual to join an innovative oncology company with an industry leading Board of Directors and Management team with significant potential to transform breast cancer treatments.  

This role is based out of either our office San Francisco or Cambridge office and requires approximately 15% (+/-) travel. 

Your work will primarily encompass: 

• Oversees clinical document quality control activities
• Proactively anticipates, identifies, communicates, and proposes clear solutions for discrepancies in TMF-related priorities
• Delivers Project Management principles to track, monitor, and deliver on all TMF-related work
• Performs analysis of monthly Quality Metrics and KPIs to identify gaps and/or compliance risks in TMF and communicates to leaders
• Effectively manages CRO relationships to ensure quality issues are resolved and deliverables are within timelines, including TMF transfers at end of study
• Develops and manages TMF Zone Owners, who will represent the Functional Areas based on the TMF Reference Model, to increase efficiencies
• Manages Veeva eTMF system access for internal and external eTMF users
• Develops reports and dashboards for study teams in Veeva eTMF
• Achieves industry-standard TMF compliance (quality, completeness, and timeliness) with the goal of Inspection Ready for all studies
• Ensures internal audits and Health Authority inspections are set-up appropriately in Veeva eTMF with access when needed
• Contributes to the design, development, and/or deployment of eTMF and represents TMF Management for all Veeva releases and enhancements
• Deploys and maintains Veeva Milestone Master Sets and Expected Document Lists in Veeva eTMF
• Supports the development of TMF-related documentation (SOPs, WIs, Job Aids, and other tools)
• May support the Veeva roadmap by collaborating with internal stakeholders and Veeva on the integration of other Veeva Platforms: RIMs, QMS with eTMF to ensure business needs are met

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge:  

• Bachelor’s degree is required. A Bachelor’s degree in a scientific field or a Master’s degree is preferred
• Expert knowledge of TMF for set-up and management
• General eTMF systems knowledge is desirable. Experience in Veeva Vault Clinical is required
• Extensive understanding of GCPs, FDA, EU, and ICH regulatory standards/guidance documents

Experience: 

• 7+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 5+ years of TMF operations experience within clinical research or pharmaceutical
• Experience with TMF transfers­
• Experience managing CROs and other external vendors 
• Experience in preparing and delivering training  
• Experience managing active, inactive, and archived records, analyzing business processes, and developing and implementing records policy and procedures
• Broad understanding of business operations in a variety of cross-functional areas

Attributes: 

• Veeva expert for cross vault applications
• Strong communication skills and the ability to effectively build productive internal and external working relationships
• Strong organizational, project management, and time management skills
• Ability to independently execute on day-to-day responsibilities
• Ability to independently exercise judgement in developing methods, techniques, and evaluation criteria for obtaining results
• Excellent attention to detail, strong critical thinking, problem solving, and managing change
• Applies technical standards, principles, theories, concepts, and techniques
• Self-motivated, eagerness to grow professionally, and commitment to self-development

The base pay range for this position is expected to be $165,000 - $190,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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