Senior Manager, Clinical Research
research_and_development › Research & Development / Clinical Research · · M4 — M4 — Director · Management
Leads a team of clinical research professionals, overseeing the design and execution of multiple clinical study protocols.
Median pay · United States · annual
$178,699 USD
▲ +95.9% vs M1 on this ladder
Typical range ()
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4 of 8
Track
Management
Family rungs priced
M1 · M2 · M3 · M4 · M5 · M6
Coordinates
3 / 4 spaces
pay@2 · 2026-07
What this role is
Leads a team of clinical research professionals, overseeing the design and execution of multiple clinical study protocols. At the Director (M4) level, the role owns a function or department, strategic priorities and cross-functional alignment, and drives function-level results. Leads managers; sets direction for the function.
What this level does
- Manages multiple trial teams or a critical clinical operations function across a program of studies, aligning monitoring strategy with development objectives
- Sets risk-based monitoring and quality policies that, if wrong, could jeopardize trial validity, inspection readiness, or program timelines
- Approves study operational plans, vendor selection strategy, and budgets across concurrent trials, resolving cross-study resource contention
- Engages senior clinical development and regulatory leaders on functional strategy, inspection preparedness, and study feasibility
- Oversees CRA managers and CTMs, building the team's capability to run appropriately complex trials and mentoring senior staff
- Knowledge applied
- Sets monitoring, quality, and feasibility policy aligned to development objectives across multiple trials or a critical function.
- Complexity & problem solving
- Strategic policy decisions where errors could jeopardize trial validity, inspection readiness, or program timelines.
- Collaboration & interaction
- Engages senior clinical development and regulatory leaders on functional strategy and inspection preparedness.
- Typical experience
- 8–10+ years with complex multi-team clinical operations leadership.
Skills at this level
- ICH GCP guidelines knowledge
- — Applies Good Clinical Practice standards aligned with E6 R3 to govern how trials are monitored, documented, and closed out, mandatory for all clinical trial work globally.
- Regulatory compliance
- — Ensures trials are conducted per applicable regulatory requirements including 21 CFR Part 11 for digital data-capture systems and maintains inspection readiness.
- Site monitoring
- — Conducts and oversees initiation, monitoring, and close-out visits, verifying source data and overseeing site performance and protocol adherence.
- Good Documentation Practice
- — Maintains accurate, up-to-date, audit-ready trial documentation and essential-document completeness in the trial master file.
- Trial close-out and reconciliation
- — Owns query burn-down and reconciliation of SAEs, labs, and drug supplies, and drives hand-offs to medical writing and biostatistics to meet CSR timelines.
- Vendor and CRO oversight
- — Orchestrates central labs, IRT, imaging, and CRO partners and provides continuous quality oversight against protocol and GCP commitments.
- Protocol development
- — Establishes trial protocols and generates study forms in compliance with GCP and ICH guidelines for the operational conduct of the study.
- Clinical trial design and planning
- — Designs and plans studies across development phases including site selection strategy, data collection systems, and study reports.
- EDC proficiency
- — Uses Electronic Data Capture systems such as Medidata Rave and Oracle InForm to collect, review, and manage clinical trial data and CRF queries.
- Site selection and feasibility
- — Assesses qualifications and feasibility of clinical trial sites and conducts site selection and initiation for appropriately complex trials.
- Communication and liaison
- — Serves as liaison between sponsors, investigators, site staff, vendors, and regulatory authorities to keep trials aligned and on schedule.
- Attention to detail
- — Reviews case report forms, source data, and trial documents with precision to ensure data accuracy and protocol compliance.
- Mentoring
- — Guides and develops junior CRAs and on-the-job monitoring trainees in site monitoring, documentation, and adverse-event procedures.
- People and departmental management
- — Manages managers, professionals, and support staff and runs a clinical operations sub-function including its budgets, policies, and objectives.
- Clinical operational strategy
- — Translates strategic and tactical development plans into clinical research operational plans and defines methods for running trials across the portfolio.
Model-authored from 15 retrieved sources, then adversarially reviewed by an independent judge panel and held to a minimum-evidence floor before publication. Distinct from corpus-extracted content, which is labelled as such.
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As of · 2026-07-30
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