Clinical Document Management Specialist
Proclinical is currently recruiting for a Clinical Document Management Specialist with a pharmaceutical company located in Foster City, CA.
- Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements
- Ensure compliance with policies, procedures, and the practices of records management/TMF archival initiative
- Work with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. filing of agreements in legal archive, Apttus, and eTMF GDAR system)
- Data mining/modeling (e.g. statistical models) and enhancing data collection procedures to identify patterns and extract knowledge from large data sets
- Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filing
- Responsible for keeping DMT Master Inventory up to date and accurate
- 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
- Work with management to develop and maintain quality assurance and control plans
- Responsible for monitoring accuracy of the team's work by providing reports and metrics to management team
- 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
- Manage the off-site storage of records for Development Business Operations agreements and collaborate closely with Clinical Records team to ensure proper process is in place for off-site archival of paper agreements
- Collaborate and partner with the Information Technology (IT) Team, through stellar communication and solid project management. Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies
- Operate as the Subject Matter Expert (SME) in the electronic TMF (eTMF)
- Respond to internal and/or external information inquiries related to contract filing and records retention of those agreements; supports internal and external audits and inspections, including provision of data on contract filing
- Contribute to the DMT mailbox by responding to daily email inquiries, review of incoming agreements for technical review and 30-day contemporaneous filing requirements and SLA turnaround time in eTMF (GDAR) and Apttus
- Participate in the development, implementation and maintenance of internal systems and processes used to manage collections of agreements and filing of documents to GDAR and Apttus
- 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.
- Support Development Business Operations Functional Teams and Clinical Operations Study Teams in understanding TMF-related responsibilities, requirements and expectations
- Manage Development Business Operations TMF protocol list for legacy and active protocols and Development Business Operations TMF Comprehensive Review Trackers and Agreements Missing in TMF
- Provide management with DMT metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level of outstanding items on a periodic and/or ad-hoc basis as requested by management
Skills and Requirements:
- 3-5 plus years of relevant experience
- BA/BS required
- 3+ years of data science experience with common data science toolkits and data visualization tools
- Good scripting/programming skill and applied statistics skills, such as distributions, statistical testing, regression, etc. preferred
- Expert in Microsoft programs including, but not limited to, MSWord, PowerPoint, Visio, Access, and Excel
- 2-5 plus years of project management experience with PMP preferred
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
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.