Clinical Data Manager / Sr. Clinical Data Manager
161 Oyster Point Blvd South San Francisco, CA 94080
**South San Francisco or home-based anywhere on the West Coast.
Clinical Data Manager (6 Month Extendable)
In anticipation of the Company’ s growth plans, we are seeking to recruit a Clinical Data Manager. The Clinical Data Manager will work in an outsourced data management model. He or she will develop strategy, lead data management activities and will interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner. This individual will also independently perform/oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data, following all applicable standard and study-specific procedures.
Your primary responsibilities are two-fold:
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.
Your other responsibilities and key result areas include but are not limited to:
Reviews protocols from a CDM perspective and provide functional-expert feedback.
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, data listing specifications, and electronic data transfer agreements.
Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor.
Oversee data cleaning activities executed by the CRO and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data.
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 project team.
Monitor vendor performance to ensure timelines and data quality standards are met.
Ensure compliance of clinical data management processes with applicable regulations and guidelines.
BA/BS or higher preferably in math, science or health-related field 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.
CNS/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.
Clear verbal and written communication skills.
Strong analytical and problem-solving skills