Location: HYBRID – 2 days per week on-site in Foster City, CA
Contract Duration: 6 months
Responsibilities:
- 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 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
- Processing, cleansing, and verifying the integrity of data used for analysis
- Doing ad-hoc analysis of department data and presenting results in a clear manner
- Work with management to manage business continuity procedures, including management of paper agreements
- 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
- Collaborate with management to generate central intake report on a daily and published in a timely fashion
- 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
- Ensure record filing is kept up to date is performed accurately by DMT members
- 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
Qualifications / Requirements:
- 3-5 plus years of relevant experience
- BA/BS required
- 3plus years of data science experience with common data science toolkits and data visualization tools
- 5 plus years of project management experience with PMP preferred
- 3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred
- Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management
W2/1099 CONTRACT CANDIDATES ONLY!!! NO C2C/CONSULTANTS!!!
