Location: South San Francisco, CA (100% onsite role once SAH order is lifted)
Industry: Biotechnology / Pharma
Type: Initial 1-year contract with chance to grow career
Level: 4+ years of Clinical Data Management Experience
Bay Area residents, who submit a cover letter will be viewed first!
An excellent opportunity to get your foot in the door with one of the leading Biotech companies in the world!
Summary of This Opportunity:
- Leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies.
- Interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met.
- Provides early strategic input into protocol design focused on data management issues
- Leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives
- Responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals
- Responsible for the implementation of standards within Study Data Management across one or more CDM study teams
- Develops and executes ad hoc database queries utilizing data review and query tools
- Manages projects resourced externally via contract research organizations (CROs) or corporate partners.
- Ability to apply advanced principles, theories and concepts for CDM team as a whole.
- B.A./B.S. Degree or equivalent and around 5 years’ experience in Clinical Data Management
- Clinical data management system experience (EDC Medidata Rave strongly preferred).
- Knowledge of core clinical data management applications:
- Clinical data management systems
- Electronic data capture
- Query tools
- Understanding of the conceptual basis for data management conventions, standards and processes.
- Good understanding of the role of data management, biostatistics and statistical programming in the drug development process.
- Ability to develop solutions to complex problems.
- Ability to multi-task and effectively set own priorities.
- Strong organizational skills.
- Strong communication and interpersonal skills.
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role*