Summary of Position

This position provides TMF expertise and leads a cross-functional team in all aspects of management of the trial master file set up, design, and oversight. Responsibilities include managing timelines, and deliverables while maintaining quality and regulatory compliance.

Responsibilities and Job Duties:

TMF Planning

• Partners, collaborates, and develops strong relationships within clinical operations and other functions, to understand the TMF needs to support corporate strategy, corporate objectives, and departmental objectives.
• Leads enterprise-wide TMF strategy and lifecycle governance across global clinical programs.
• Monitor technological advances and regulatory evolution and provide an analysis of TMF trends and changes including recommendations to the head of clinical operations for consideration.
• Leads cross-functional alignment across Clinical Operations, QA, CROs and relevant external partners to drive TMF excellence.
• Provides input into and/or drives the development of TMF operating procedures, work instructions, training materials, and tools.

TMF Delivery and Management

• Owns the vendor governance framework, including KPIs, financial oversight and the escalation management for the TMF across all global clinical programs.
• Work with the head of clinical operations systems to ensure continuing governance with the third-party vendors and that their support is aligned with departmental strategy, goals, and budget.
• The Senior Manager of TMF Operations is responsible for all aspects of the 3rd party governance with input and oversight from the head of clinical operations systems including determination of key metrics to maintain oversight (% completeness, vendor performance, etc.)
• Partner with CROs to ensure that system requirements for each trial are set up and delivered per timelines, quality, and budget, and that the end-of-study TMF integration is achieved.
• Manage and lead TMF-related projects to ensure smooth system delivery and sound project management practices.
• Maintain effective communication with clinical study teams, CRO staff and TMF vendor personnel throughout study start-up, maintenance and close out.
• Propose, drive and support process improvement initiatives related to the TMF as required.
• Lead projects to create, maintain and improve milestones and expected development tracking, timeline reports and dashboards for the TMF.
• Perform general administrative tasks related to the TMF as required by the clinical study teams, directors, and the head of clinical operations systems.

TMF Inspection Readiness:

• Work with audit inspection readiness teams, as needed, with a focus on preparing and supporting study teams for GCP and pre-approval related inspections on study TMF compliance and completeness.
• Drives inspection readiness strategy, proactively identifying and mitigating TMF risks to ensure successful regulatory inspections.

TMF Subject Matter Expertise

• Act as the TMF thought leader within MacroGenics, driving innovation through adoption of emerging technologies and industry best practices.
• Provide principal leadership as the technical consultant for the TMF to ensure that changes and updates are implemented, and the system maintained appropriately.
• Ensure awareness of trends in the industry in the field of innovation in trial management by scanning external and internal operational trends and evaluating new innovative technologies and practices.
• Represent TMF technology innovation in trial management and develop a presence in industry-level forums. Act as representative on behalf of the head of clinical operations systems for select meetings and provide updates at operational and staff-wide meetings as required.

Minimum Qualifications

Education and Experience:

• Bachelor's degree, with preference in physical, life sciences or computer sciences.
• 7-10 years pharmaceutical industry or CRO experience with at least 4 years in trial management systems, clinical operations, and/or related clinical systems/technology innovation position.
• Minimum of 4 years of exposure to using TMF on multiple domestic and international trials

Knowledge, Skills, and Abilities:

• Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) and E6(R3) guidelines
• Demonstrated knowledge of TMF systems, specifically Veeva TMF.
• Understanding of the global drug development process, including international standards, health authorities and country/local regulatory requirements.
• Demonstrated leadership in leading cross-functional teams and high-level project management expertise.
• Demonstrated qualitative and quantitative skills in redesigning processes, improving productivity, and improving efficiency.
• Ability to work independently with minimal oversight, however, is aware of when to escalate issues.
• Excellent strategic thinking skills
• Demonstrated matrix management skills and ability to influence internally and externally.
• Excellent communicator and presenter
• Experience with direct line management of team members or contractors
• High level of competence and skill with TMF, web-based collaboration tools (MS Teams, SharePoint, etc.)
• Willingness to travel up to 25%

Supervisory Responsibilities

• Mentor and develop junior staff
• May manage staff as required

Additional Information

The annual rate of pay for this position ranges from $144,300-$220,000. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.