Job Details

The Opportunity:

As a Clinical Operations Trial Master File Specialist, Clinical Operations, you will be part of the Clinical Operations Excellence (CORE) team. In this role, you will support the management of TMF processes, and may assist the study-specific TMF Managers and Clinical Operations Leads in the cross-functional management of TMF for clinical studies. 

Responsibilities:

• Adhere to applicable Standard Operating Procedures (SOP), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) Guidelines, and ALCOA+ principles.

• Review and update of TMF Plan/Index for assigned studies.

• Support record clean-up initiatives concerning study-specific mailbox management. This includes review of emails to determine appropriateness for filing in the TMF.

• Submit TMF records to the study-specific eTMFs.

• Facilitate eTMF access requests.

• Identify trends which could improve the quality of clinical studies and data collection processes.

• Reconcile essential documents to avoid duplication.

• Partner with cross-functional study teams and services providers to timely resolve issues.

• Manage collection of TMF metrics, KPIs, dashboards.

• Collaborate with the study team to maintain TMF timelines.

• Communicate TMF filing status to cross-functional teams to ensure study goals are met.

• Conduct ongoing TMF oversight activities for service providers.

• Offer guidance for best practices related to TMF management and oversight activities, as appropriate.

• Develop successful working relationships with service providers for TMF management.

• Participate in study-specific TMF meetings with RevMed and service providers, as appropriate.

• Drive a culture of quality and compliance that aligns with ICH/GCP guidelines, regulatory requirements and internal policies.

• Participate in audit, inspection readiness preparation and inspection activities as needed.

• Support with the creation and maintenance of study-specific storyboards.

• Participate in other Clinical Operations Excellence activities as appropriate.

Required Skills, Experience and Education:

• Bachelor’s degree preferably in biological sciences or health-related field.

• 2 years minimum of in depth TMF management experience.

• Experience with successful TMF oversight.

• Strong working knowledge with the CDISC TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standard and regulatory requirements related to document management.

• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace.

• Excellent written/verbal communication, interpersonal skills and decision-making skills.

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

• Proficient in SharePoint and various eTMF platforms such as Veeva, Trial Interactive, Wingspan, FLEX.

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

• Travel may be required, if remote (~25%).

Preferred Skills:

• TMF certifications.

• Experience with development of eTMF processes and policies.

• Experience working with service providers.

• Oncology experience, early and/or late stage.