Proclinical is currently recruiting for a Documentation Specialist for a leading pharmaceutical company located in Southern San Francisco, CA. Successful candidate will have at least 3 years of experience in clinical trial management or project management and with TMF/eTMF, Veeva, and/or PMP.
- Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements
- Collaborate with Development Business Operations leadership, Development Business Operations functional groups, clinical operations teams, and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of records management/TMF archival initiative
- Work with management to manage business continuity procedures, including management of paper agreements
- Evaluate regulatory and business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with all
- Responsible for the continued maintenance of eTMF (GDAR) and Apttus contract filing
- File incoming documents and retrieve copy of paper protocol agreements from TMF room for Apttus filing
- Ensure record filing is kept up to date is performed accurately by DMT members
- Develop and maintain quality assurance and control plans
- Responsible for monitoring accuracy of the team's work by providing reports and metrics to the management team
- Responsible for leading assigned meetings/projects and will mentor/help more junior staff with complex initiatives
- Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents
- Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying clinical records
- Operate as the Subject Matter Expert (SME) in the electronic TMF (eTMF)
- Track and maintain departmental metrics related to operational activities, progress of contract filing and archive, quality measurements and other variables. Develops appropriate tool sets for capturing metrics and generating reports.
- Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival
- Ensure appropriate documentation completed to track archival of files
- Support Development Business Operations Functional Teams and Clinical Operations Study Teams in understanding TMF-related responsibilities, requirements and expectations
Skills and Requirements:
- 3+ years of experience in clinical trial management or project management and with TMF/eTMF, Veeva, and/or PMP
- BA or BS required
- Exemplary interpersonal skills with proven demonstration
- Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management
- Expert in Microsoft programs including, but not limited to, MSWord, PowerPoint, Visio, Access, and Excel
- The Sr. Associate needs subject matter expertise in Trial Master File (TMF) Quality and Records Management.
- The Sr. Associate has foundational skills in Influencing and Leadership and demonstrates advanced Teamwork skills. Must have foundational abilities in all TMF and contract filing technical competencies, including Quality Management and Change Management
- PMP and/or Veeva
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.