Clinical TMF Manager, Clinical Operations

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical TMF and Systems Manager you will be responsible for acting as a central contact for the Clinical Study Execution Teams (CSETs) for Trial Master File (TMF) management and participating in the development of quality oversight processes for TMF management of RevMed’s clinical trials. Additional responsibilities include the upload, review, and approval of TMF documents, co-authoring and managing TMF documents such as TMF Plan, Index, SOPs, and other guidance documents and ensuring quality management by reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues (e.g., CAPAs). Support Clinical Operations Management in high-level projects, developing processes, strategies and conducting training for TMF stakeholders. Responsible for overseeing the activities of the TMF Specialist(s) and external vendors, ensuring that study documents are adherent with ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready.

Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines

• Be a primary lead with eTMF and CTMS integration/implementation/maintenance, user training, team advisor and assist in managing oversight for the RevMed clinical trial TMFs and CTMS within timelines and designated program budgets.

• Provide strong support to establish and manage quality oversight of TMF and CTMS, including TMF metrics and KPIs.

• Partner with Clinical Study Execution Teams (CSETs), CROs/vendors and cross-functional team members to align TMF activities, as needed.

• Responsible for vendor and internal implementation and maintenance process for cataloging, filing, retrieving, storing, preserving, and protecting CTMS outputs and TMF records (paper and electronic).

• Develop successful working relationships with service providers (vendors) and CROs on TMF management including review process, ensuring TMF completeness and managing the transfer for TMF records as needed.

• Provides TMF SME audits and inspections support.

• Contributes to and implements TMF planning and strategy development, which may include evaluation of possible options for on and off-site locations.

• Use all available tools to track, analyze, oversee, and report CTMS and TMF health metrics and status to all key stakeholders.

• May be responsible for direct TMF management activities, e.g., for assigned study TMF(s)

• Responsible for contributing to risk management, contingency and scenario planning.

• Analyze and report TMF health metrics by study to be shared with stakeholders.

• Supervise, communicate system status, issues and problem solves to ensure project team goals are met.

• Actively contribute to the selection and management of eTMF, CTMS and other Clinical System solutions / vendors, including development of Requests for Proposals (RFPs)

• Anticipate obstacles, difficulties, be solution-oriented, proactively provide risk assessment and mitigation strategies to achieve goals.

• Participate in and/or co-lead departmental or interdepartmental strategic business initiatives, as well as contribute to SOP development, implementation, and training.

• Manage staff through mentorship and may supervise TMF specialist(s) or similar as direct reports.

• Assists in the hiring, development, and retention of top talent within the team. Coaches direct report(s) on their performance, development, and career interests.

• Participate in other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

• RN or bachelor’s or master’s degree desired.

• Minimum of 8+ years working in a pharmaceutical or other highly regulated corporate environment.

• Minimum of 6 years’ experience working in the Records Management field, including 4+ years’ experience using electronic records management systems. Relevant indirect experience may also meet this requirement.

• Strong experience collaborating with the DIA (CDISC) TMF Reference Model.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

• Strong experience in Trial Master File requirements and set up.

• Strong knowledge of electronic document management systems, document archival systems: (eTMF) and CTMS systems.

• A clear understanding of the clinical development lifecycle and the technologies associated with the activation and management of clinical trials and study sites.

• Ability to successfully oversee study TMFs including development of relevant processes and policies.

• Experience in selection of CROs/vendors and management of external resources.

• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Excellent written/verbal communication and people skills.

• Strong decision-making skills.

• High sense of priority and commitment to excellence in the successful execution of deliverables.

• Ability to analyze operational data, contribute with a mindset focused on quality, timeliness and fiscal responsibility, drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Process and Systems team.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills:

• Has direct experience working with eTMF systems.

• Has familiarity collaborating with vendor systems/portals (e.g., CTMS).

• Oncology experience, early and/or late stage, preferred.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

• Experience managing direct reports(s). 

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