Senior Clinical Operations Regulatory Specialist

The Senior Clinical Operations Regulatory Specialist will be responsible for ensuring that SDP Oncology studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections according to Veeva processes. Ensure accountable functions are in compliance with the requirements of the TMF SOP and Veeva work instructions. Support, consult and provide TMF guidance to staff during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.

Responsibilities

  • Responsible for system administration and overall system maintenance.
  • Responsible for training all users of the eTMF and ensuring training program is kept up to date with system and procedure trainings.
  • Responsible for overall quality, maintenance, and completeness of Trial Master Files.
  • Identify trends or quality concerns and oversee resolution of any issues.
  • Work closely with Information Technology to ensure system validation is maintained.
  • Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
  • Act as a liaison between the Site IRBs and Clinical team to resolve queries and concerns.
  • Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews.
  • Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
  • Provide mentorship and training to junior members of the team.
  • Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
  • Author and/or contribute to SOP, WI, and Job Aids to ensure robust training of TMF management.
  • Other duties as assigned.

Professional Experience/Qualifications

  • 2-3 years of clinical research experience in academic and/or industry settings; oncology experience strongly preferred.
  • Prior eTMF administration required.
  • Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
  • Knowledge of, and direct experience with Trial Master Files, experience with electronic TMF systems is required.
  • Fundamental knowledge of the conduct of clinical trials is preferred.
  • Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
  • Must be able to work independently and professionally.
  • Must have ability to coach and oversee junior members of a team and serve as an escalation point within the team.
  • Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or related field.

 

Job Location: Cambridge, MA

Equal Opportunity Employer

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