Senior Clinical Data Manager

Redbock - an NES Fircroft company; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a seasoned Clinical Data Management (CDM) expert to lead data management activities on assigned clinical studies within multidisciplinary project teams. You will drive high-quality data delivery for analysis and milestone achievements.

The role requires oversight of CRF design, database specifications, data cleaning, and regulatory compliance (ICH/FDA, CDISC). You will coordinate with DM vendors, Biostatistics, Data Science, and Medical Monitors to

Qualifications

• Bachelor's degree as stated; 10+ years of clinical data management experience in biotech/pharma.
• Strong knowledge of regulatory/data standards (ICH/FDA, CDISC).
• Experience leading CDM deliverables across Phase 1–3 trials and later-stage studies.

Responsibilities

• Serve as data management expert and CDM lead for assigned 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 CDM deliverables.
• Manage / oversee study setup, testing and system validation for new studies with the DM vendor.
• Oversee data cleaning activities and ensure protocol-specified guidelines are applied to review and cleaning of data.
• Collaborate with Data Science, Biostatistics, and Medical Monitor to identify critical variables and coordinate them in DM vendor activities.
• Develop and manage timelines for key CDM deliverables in coordination with vendors and project teams.
• Monitor vendor performance to ensure timelines and data quality standards are met.
• Ensure compliance of CDM processes with applicable regulations and guidelines.

Skills

Clinical Data Management

CDM Leadership

Regulatory Compliance

Cross-functional Collaboration

Vendor Management

Education

Bachelor's degree in mathematics, science, or health-related field

Job description

• 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.

Other Responsibilities

• 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 ensures 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 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

• Typically requires a Bachelor's degree in mathematics, science, or a health-related field and a 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
• Capable of proactively identifying project risks and proposing strategic solutions; excellent multi-disciplinary interpersonal and communication skills
• Strong analytical and problem-solving skills; able to work independently and within cross-functional project teams