Clinical Studies Specialist

Position Title: Clinical Studies Specialist - 100% Remote

Duration: 2 yrs

What are the top 3-5 skills, experience or education required for this position:

• Bachelor's degree or international equivalent preferred. Minimum 4 years relevant industry experience in clinical document management or equivalent experience required. If no BS, a total of 6 years professional clinical research relevant work experience.
• Proven analytical and critical thinking skills.
• Proficient knowledge of clinical documentation business procedures and compliant to clinical documentation processes, identify gaps and propose solutions.
• Capable of working autonomously with limited oversight.
• Proven oral and written communication skills; ability to facilitate cross-functional team meetings.

Purpose:

• Performs key operational activities across the Clinical Documentation Center for master files through life cycle.
• Collaborates with Master File Owners to support inspection readiness of clinical documentation / master files.
• May be aligned by Therapeutic Area but expected to work across all areas of the organization.

Responsibilities:

• Applies critical thinking to ensure real-time inspection readiness of clinical documentation by:
• Investigates and proactively resolves issues
• Runs and performs review of reports and dashboards within eTMF
• Produces eTMF metrics
• Communicates to Master File owner(s) "root cause" analysis and potential data integrity concerns
• Leads to completion of the final reconciliation/review and archival of individual master files, working closely with the Clinical Documentation Associate (CDA), CDC leadership and other TMF stakeholders (i.e., CPD, SM&M, DSS, BSO).
• For CRO managed study TMFs:
• Conduct QC of artifacts (may also include uploading and classifying)
• Involvement with transfer of CRO TMFs into eTMF system
• Provides audit and inspection preparation support for paper and electronic TMFs, to include, but not limited to (on selected master files):
• Conduct data integrity checks
• Run & analyze reports for TMF completeness
• Work with the assigned CDA to follow-up on outstanding items with other functional areas
• Contribute to completion of pre-inspection requests
• During an inspection:
• Function as the subject matter expert of the eTMF system navigation, including being present in the "front room" with the Auditors/Inspectors
• Participate in responding to auditor/inspector requests (may be required to put the response together)
• Conduct TMF conversion activities; involvement with the transfer of TMFs from external entities (i.e., CRO, other pharmaceutical companies).
• Review regulatory documents / packages for approval of Investigational Product (IP) release and work with Artifact Owner(s) to correct errors.
• Provide approval for release of IP to investigator sites.
• Provides suggestions for CDC work instructions/job aides and contributes to functional area continuous improvement projects and/or work streams.
• Complies with GCP, SOPs and functional area processes.