Bayside Solutions · 6 hours ago
Senior Clinical Data Manager
United States
Contract
Remote
Senior Level
$166K/yr - $187K/yr
5+ years expBayside Solutions is seeking a Senior Clinical Data Manager Contractor to work in an outsourced data management model. The role involves developing a strategy, leading data management activities, and ensuring high-quality data management services for clinical studies.
Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality
No H1B
Responsibilities
Serve as a data management expert and, if assigned, 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 provides functional-expert feedback
Review and approve key clinical data management deliverables generated by a DM vendor, 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
Perform / Oversee data cleaning activities executed by the DM vendor and ensure protocol-specified guidelines are applied to the review and cleaning of clinical data
Collaborate with internal Data Science (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 DM vendor activities
Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and the 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
Qualification
Required
BA/BS or higher, preferably in math, science, or a health-related field, with a minimum of 5+ years of experience in clinical data management across phase 1- 3 clinical trials
At least 5 years of overall experience acting as a study lead data manager
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 multidisciplinary project teams and develop productive relationships with external vendors
Clear verbal and written communication skills
Strong analytical and problem-solving skills
Preferred
CNS/Neurodegenerative trial experience is greatly preferred
Experience in all study phases, including early phase and dose escalation studies, is greatly preferred
Company
Bayside Solutions
Bayside Solutions is a staffing and recruiting company offering IT, telecom, and scientific staffing services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
B
Bob Klotz
Founder
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