Senior Clinical Data Manager
Emeryville, CA | Contract
Bayside Solutions is seeking a Senior Clinical Data Manager to be part of our Client’ s team in Emeryville. This is an opportunity to work with a Global healthcare company focusing on improving the health and well-being of people around the world.
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.
Senior Clinical Data Manager
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
- Lead CRF design & guidelines for population of CRFs.
- Work with clinical operations group, biostatisticians, SAS programmers to develop CRFs to ensure required information is captured for statistical analysis.
- Implementation of CRFs in the database & assuring that the database for each study is live in a timely manner.
- Oversight of all clinical data management activities, database cleaning & lock activities including developing data management plans, supervising database development & reviewing & processing clinical trial data to ensure completeness, accuracy & consistency of clinical trials databases.
- Lead interactions between company & outside vendors on the collection, transmittal & transfer of study specific instrument & laboratory data.
- Participate in cross functional team meetings & communicate with all departments regarding project statuses/issues
- Work with biostatisticians & SAS programmers to harmonize data collection, compile & maintain SAS data standards.
- Provide review & oversight on quality database design, validation, & deployment to ensure quality & efficiencies through data & process standardization.
- Review clinical study protocols, statistical analysis plans & ensure data quality for data analyses.
- Take a leadership role in the review & query of clinical data. This includes participation of the critical review of data-populated tables, figures, & listings as part of the database clean-up & prior to database lock.
- Educate study team members by preparing & distributing study related reports, resolving questions & providing clinical data management guidance.
- Assure regulatory compliance of vendors & investigational sites with company SOPs, FDA & ICH guidelines, & other applicable regulations & guidelines.
- Develop & maintain appropriate data management SOPs (associated with the data collection, h&ling & review processes to meet regulatory compliance & operational needs).
- Assist in addressing Regulatory Submission issues within Biostatistics & with other related departments.
- Assist with response to questions & findings from audits at the study/vendor level.
- Utilize appropriate CDM concepts & resources to solve moderately complex technical CDM issues.
- Ensure data management procedures & projects have set timelines & meet established deadlines.
- Manage & maintain effective communication with project management.
- Serve as a technical resource for data management related activities; troubleshoot technical problems.
- Bachelor’ s degree, with 5+ years of CDM experience, including working under Good Clinical Practices and FDA regulations & guidance.
- Experience w/CRF design, clinical database setup, managing external data & clinical data cleaning.
- Comprehensive experience working w/clinical database systems & electronic data capture.
- Experience managing vendors & data management activities from project initiation through database closeout.
- Experience with Electronic Data Capture (EDC).
- Excellent verbal & written communication skills & strong interpersonal skills.
- Experience managing Clinical Research Organizations (CROs)
- Familiarity with clinical data management systems.
- SAS programming experience a plus.
- Analytical & Communication skills.
- Planning & Co-ordination skills.
- Experience with project management.
- Experience with DataTrak a plus.