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Manager, Clinical Data Management
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Posted: 10/16/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing early-phase clinical trials, particularly in Immunology, with a strong focus on compliance with GCP and ICH guidelines. Proven ability to lead cross-functional teams, mentor junior staff, and effectively communicate complex scientific information.
Highest-signal resume keywords
Phase 1 Clinical Trial ExperienceImmunology Clinical Programs ManagementGCP And ICH ComplianceScientific And Medical WritingComplex Project Management
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Provide clinical operational leadership for the design, planning, and execution of early-phase clinical trials and programs
- Execute Immunology programs including multiple Phase 1 and 1b trials across programs and developmental stages
- Manage cross-functional team performance to achieve trial objectives and address issues
- Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements
- Assess clinical safety and manage compound risks
- Provide real-time oversight of ongoing trials and identify and mitigate participant, study design, data, and conduct issues
- Review clinical trial data and participate in on-site study monitoring, including site training and supervision of complex endpoint/biomarker collection
- Represent Early-Stage Development Clinical Operations on development teams
- Lead departmental job aids/SOPs and participate in global clinical development procedure teams
- Identify and communicate organizational best practices
- Coach, mentor, and develop junior team members
- Represent the company at professional events and present clinical initiatives, projects, and trial results
- Author clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory responses, and other clinical/regulatory documents
- Develop study operational documents, including monitoring plans, laboratory manuals, risk language, and informed consents
- Author and coordinate WMA/CTD subsections
- Assist Clinical Directors with scientific leadership, publications, meeting presentations, and due diligence
- Lead, direct, or support study planning, development, and execution activities
- Manage trial and program projects, team meetings, collaborative workspaces, and document management
- Provide risk assessments and contingency planning under accelerated timelines
Requirements
What you’ll need- Degree in Life Sciences
- Bachelor’s degree and ≥11 years related experience, OR Master’s degree and ≥8 years related experience, OR PhD/doctorate degree and ≥3 years related experience
- At least 3 years Phase 1 clinical trial experience
- Experience developing, implementing, and managing immunology clinical programs and trials in healthy participants and/or patients
- Experience with immunology early patient trials preferred
- Ability to navigate ambiguity and drive results
- Ability to solve complex problems and use independent judgment relating to regulations, guidelines, and investigator interactions
- Ability to develop scientific knowledge across therapeutic areas
- Excellence in complex project management and managing multiple projects/priorities
- Excellence in scientific, medical/safety writing, and reporting
- Ability to make data-driven decisions and identify, escalate, and mitigate potential issues
- Ability to partner effectively with external teams
- Effective written and oral communication, problem-solving, and analytical skills
- Working knowledge of GCP, ICH guidelines, and regulatory requirements
- Ability to mentor junior staff
- Leadership or participation in a cross-functional initiative addressing a business gap or process improvement
- Must act with courage and candor
- Advanced degree desirable
- Global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submission experience a plus
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangement
- Domestic relocation
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial DesignRisk AssessmentData AnalysisProtocol DevelopmentRegulatory Document AuthoringMonitoring Plan DevelopmentEndpoint/Biomarker CollectionStudy Operational Document DevelopmentContingency PlanningSafety Reporting
Soft Skills
Problem-SolvingEffective CommunicationMentoringLeadershipAnalytical Skills
Industry Keywords
Life Sciences DegreeClinical OperationsEarly-Stage DevelopmentGlobal Phase 1 TrialsNDA SubmissionWMA SubmissionRegulatory RequirementsClinical Safety ManagementCross-Functional Team LeadershipStudy Monitoring