Clinical Data Manager
151 Oyster Point Blvd, South San Francisco, CA 94080
Our client in South San Francisco is looking to have a Clinical Data Manager join their growing team! This is an opportunity to work with a great Biotechnology company focused on the discovery and development of therapies for patients with neurodegenerative diseases, including Alzheimer’ s disease, Parkinson’ s disease, ALS and others.
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.
Clinical Data Manager
- An opportunity to significantly impart the future of the company’ s operations
- A competitive base salary
- On the job training, both in person/online
Summary of Responsibilities:
- Serve as a data management expert and be the CDM lead for assigned clinical studies on multidisciplinary project teams.
- Deliver high quality data for analysis and study milestones.
- Reviews protocols from a CDM perspective and provide functional-expert feedback.
- Oversee data cleaning activities executed by the CRO and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data.
- Review and approval of database (DB) technical specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
- Review and approve key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding and electronic data transfer agreements.
- Manage/oversee all vendor activities and staff assigned to the company' s studies including consultants to ensure maximal contribution(s) to clinical programs.
- Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor.
- Oversight of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
- Collaborate with internal Statistical Programming, internal Biostatistics, and internal Medical Monitor on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into CRO DM activities.
- Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management CRO and Denali project team.
- Assist in/oversee defining data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Manage program-wide DM activities (e.g. database design, critical variables, data review listings, data qc activities etc.) to ensure consistent data quality within a program.
- Monitor vendor performance to ensure timelines and data quality standards are met.
- Ensure the use of a standard CRF library aligned to CDISC standards when available; or ensure a logical, consistent data format is implemented which enables SDTM mapping.
- Ensure compliance of clinical data management processes with applicable regulations and guidelines.
- Bachelor’ s degree or equivalent with a minimum of 5+ years of experience in clinical data management across phase 1- 3 clinical trials.
- At least 3 years of the overall experience require acting as a study lead data manager.
- Experience on dose escalation studies is greatly preferred.
- Neurodegenerative trial experience is greatly preferred.
- Comprehensive experience working with clinical database systems.
- Working knowledge of CDISC including CDASH, TAUG and SDTM as well as data privacy regulations e.g. GDPR.
- Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities.
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.