We have an exciting opportunity for a Clinical Contracts Associate to join a leading Biotechnology client in Foster City, CA.
This will be a 6-month contract with opportunity to extend.
Key Accountabilities/Core Job Responsibilities:
- Maintain up-to-date knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements.
- 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/modelling (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.
- 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.
- Responsible for keeping DMT Master Inventory up to date and accurate.
- Potential lead of assigned meetings/projects and will mentor/help more junior staff with complex projects.
- Operate as the Subject Matter Expert (SME) in the electronic TMF (eTMF).
- Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival.
- 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.
- 3-5+ years of relevant experience (particularly in Program/Project Management 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.
- 2+ years of project management experience with PMP preferred.
- 3+ years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred.
- 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.
This position will have fast processes, so apply today.