Director, Clinical Documentation and Systems Operations

About the Role >>> Director, Clinical Documentation and Systems Operations 

As the Director, Clinical Documentation and Systems Operations, reporting to the Vice-President, Clinical Development Operations, you will lead and support Trial Master File (TMF) activities with the clinical study teams and be the study document subject matter expert (SME), advising and guiding clinical study teams on management of clinical trial study documents. In addition, you will be responsible for implementing new external clinical system vendors and working with IT to build internal clinical systems.  This person will develop and ensure that all clinical systems are operating effectively to assist the clinical trial teams during study conduct.

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:

• Lead design of internal and external clinical systems in collaboration with IT including but not limited to eTMF, IRT, CTMS, etc.
• Provide oversight of training, guidance, and coaching standards of clinical systems to clinical staff members
• Establish process initiatives for clinical document management and clinical trial records (e.g., Trial Master Files)
• In collaboration with Clinical Compliance and Quality, drive the development and reporting of metrics and KPIs related to inspection readiness, quality, system oversight, TMF completeness, and performance
• Use audit and quality review findings to assess status across programs, studies, countries, or sites to evaluate inconsistencies, gaps, and trends in compliance of processes that might require process updates/improvements or re-training
• Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes
• Collaborate with functional area representatives to escalate and resolve issues identified during quality reviews and ensure submission-readiness and inspection-readiness of TMFs, as needed
• Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and other clinical systems
• Maintain quality oversight of clinical systems vendors including vendor selection process, changes in scope, and membership in Joint Operating Committees (JOCs)
• Development and oversight of management and maintenance of TMF repositories, including supporting filing, scanning, QC, and inventory of paper documents
• Conducting and supporting ongoing inspection readiness TMF checks throughout study conduct to assess compliance with study-specific and organizational processes and ICH-GCP and applicable national and local regulations (i.e., establishing scheduled periodic quality checks to establish “health status” of the ETMF/inspection readiness)
• Authoring and reviewing internal and external TMF and clinical systems related SOPs and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes, risk-based QC processes etc.) including working with the cross-functional study team to obtain necessary input
• Supporting internal and external audits and inspections, including supporting study teams with locating and providing study documents, speaking to TMF processes, and assisting with addressing and resolving issues, as applicable
• Manage training records, user account access, role assignments, and deactivations
• Partner with Clinical IT to support the strategic lifecycle of eTMF including, but not limited to version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management
• Lead TMF governance meetings with vendors to ensure oversight, compliance, and standardization across studies or programs
• Ad hoc support of activities within Clinical Development Operations team to help meet timelines and objectives. This may include support with archiving, document collection and processing, document QC and review, and/or start-up activities

Supervisory Responsibilities

• Manage supportive oversight of TMF and clinical system function (e.g., TMF Oversight Specialists) by providing oversight and guidance of task execution as required to ensure regulatory compliance of protocol activities, if appropriate
• Accountable for ensuring all study deliverables and milestones are achieved with quality and within timelines
• In partnership with IT, ongoing maintenance of eTMF and other clinical systems

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 or higher in a scientific discipline required
• Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process
• End-to-end knowledge of clinical trials
• Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
• Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA
• Electronic Document Management applications (e.g., eTMF, EDMS etc.)
• Thorough knowledge of start-up, conduct, and maintenance of clinical systems including but not limited to eTMF, IRTs, CTMS, etc.

Experience:

• 15 years of clinical research/ biotech/ pharmaceutical experience with at least 7 years experience leading or supporting TMF, clinical document activities, and other Clinical Systems (IRT, CTMS, etc.)
• At least 2 years of people management experience
• General management and Vendor management experience
• Assisting with internal and Regulatory Authority inspections and Inspection readiness assessments with minimal guidance
• Presenting high level presentations, both orally and in writing using organizational skills to complement this
• Delivering open and honest constructive (positive and/or negative) feedback pertaining to work in hand independently
• Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies

Attributes:

• Highly motivated and enjoys working in a fast-paced, dynamic environment
• Ability to work independently with minimal supervision and within global, cross-functional team matrices
• Excellent teamwork and collaboration skills and enjoys working in a team environment
• Taking responsibility and ownership for entrusted tasks; seeing tasks through to completion
• Being flexible to innovative ideas and approaches, changes of plans, objectives and/or priorities
• Ability to handle disjointed tasks effectively in a highly collaborative, multidisciplinary team setting
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail
• Positive, flexible, self-starter, and thrives under pressure, excellent written and verbal communication skills, and strong commitment to producing high-quality work

Highly Preferred:

• Prior experience with Veeva Vault eTMF or other Veeva Vault platform applications, clinical operations (e.g., CTA, CRA/IH-CRA, Trial Manager, etc.), and/or clinical quality assurance (e.g., GCP auditor) background, with an interest in Trial Master File and inspection readiness
• Proficiency in Microsoft Word, PowerPoint, Project, Excel, SharePoint, Adobe Acrobat, and TMF
• Experience with other clinical systems preferred (e.g., CTMS etc.)

The base pay range for this position is expected to be $210,000 - $225,000 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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