Study Data Manager II
350 DNA Way, SSF35 South San Francisco, CA 94080
Bayside Solutions is seeking a Study Data Manager II to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Study Data Manager II
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Acts as a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams.
- 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 or corporate partners.
Summary of Qualifications:
- B.A./B.S. or equivalent with a minimum of 5 years’ experience in Clinical Data Management
- Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite).
- Clinical data management system experience (EDC Medidata Rave preferred).
- Ability to apply advanced principles, theories and concepts for CDM as a whole.
- 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.