Senior Clinical Data Manager (CDM)

About the Role

In anticipation of the Company's growth plans, we are seeking to recruit a Senior Clinical Data Manager (CDM) Contractor. The Senior CDM Contractor will work in an outsourced data management model, developing strategies, leading data management activities, and interfacing with the project team to ensure consistent, high-quality delivery of data management services.

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.
• Review protocols from a CDM perspective and provide 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.
• 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, Biostatistics, and Medical Monitor on identifying critical variables in the clinical dataset for protocol-specified endpoints and 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 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.

Requirements

• Bachelor's degree in mathematics, science, or a health-related field.
• Minimum of 10 years of clinical data management experience in biotech, pharmaceutical, or health-related industries.
• Demonstrated proficiency leading CDM deliverables across Phase 1-3 clinical trials, including early-phase and dose-escalation studies.
• Solid understanding of the clinical drug development process and regulatory/data standards (ICH/FDA, CDISC - CDASH, SDTM, ADaM - GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, GDPR).
• Demonstrated understanding of the clinical trial database life cycle, including CRF design, development/testing, discrepancy management, data quality review, and database lock.
• Ability to proactively identify project risks and propose strategic solutions.
• Excellent multidisciplinary interpersonal and communication skills.
• Strong analytical and problem-solving skills; able to work independently and within cross-functional project teams.

Qualifications

• Clinical data management experience in Phase 1-3 clinical trials, early-phase studies, and dose-escalation studies.
• CDM leadership experience in outsourced data management models.
• Vendor oversight and management experience.
• Expertise in clinical database lifecycle, including CRF design, database setup, testing, and system validation.
• Knowledge of data management plans, edit check specifications, and data entry guidelines.
• Experience with data cleaning, discrepancy management, and data quality review.
• Familiarity with SAE reconciliation, medical coding, and electronic data transfers.
• Understanding of clinical protocols, study timelines, and regulatory compliance.
• Experience collaborating with statistical programming, biostatistics, and medical monitoring teams.
• Knowledge of ICH, FDA regulations, CDISC standards (CDASH, SDTM, ADaM), GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionary, and GDPR.

Pay Rate: $80 - $90 per hour
Location: South San Francisco, CA - Remote Role
Note: Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Candidates must qualify as a W2 candidate.