Clinical Trials Administration – Management — M2
CLINIC.CLINICAL90BC.M2
Management track for clinical trial operations leaders who plan, staff, and deliver clinical studies. Unlike Clinical Monitoring (CRA site-facing data verification) or Data Management (EDC/database) focuses, this focus owns the operational management of study delivery — coordinating timelines, vendors/CROs, budgets, and CTA/CRA teams to ensure GCP-compliant execution across start-up, conduct, and close-out.
Management track for clinical trial operations leaders who plan, staff, and deliver clinical studies. Unlike Clinical Monitoring (CRA site-facing data verification) or Data Management (EDC/database) focuses, this focus owns the operational management of study delivery — coordinating timelines, vendors/CROs, budgets, and CTA/CRA teams to ensure GCP-compliant execution across start-up, conduct, and close-out.
Focus — Clinical Trials Administration – Management
Management track for clinical trial operations leaders who plan, staff, and deliver clinical studies. Unlike Clinical Monitoring (CRA site-facing data verification) or Data Management (EDC/database) focuses, this focus owns the operational management of study delivery — coordinating timelines, vendors/CROs, budgets, and CTA/CRA teams to ensure GCP-compliant execution across start-up, conduct, and close-out.
Material PAY differential vs the function baseline.
Responsibilities by level
What this person actually does at each level on the management track — escalating scope, not one generic blob. Your level is highlighted.
- Supervises a unit of Clinical Trial Assistants and junior CRAs in day-to-day study support, scheduling subject visits, and source document filing to keep one or more studies on track
- Oversees eTMF control, IRB documentation, and ICF version management for assigned studies to ensure inspection-ready trial master files
- Follows up on issues identified during monitoring visits and confirms corrective actions are completed within established timelines
- Ensures the team conducts trial activities in accordance with protocol, GCP, and regulatory and ethical guidelines, escalating deviations to the study manager
- Tracks short-term study milestones and unit budget line items (e.g., site payments, visit logistics) against plan
- Leads a skilled team of CRAs/CTAs through the day-to-day delivery of one or more studies across start-up, conduct, and close-out, owning tactical timeline and quality outcomes
- Coordinates vendor activities, monitoring schedules, and site-level budgets, applying judgment within known protocol and regulatory factors
- Oversees monitoring quality and verifies GCP compliance across assigned sites, resolving routine data and site issues with cross-functional partners
- Coaches, develops, and trains junior CRAs and CTAs on core competencies including monitoring practices and CTMS/eTMF use
- Manages study risks and issues via risk registers and aligns clinical, data management, and safety contributors on tactical resolution
- Manages a study or set of studies end-to-end from design and planning through clinical report generation, with accountability for operational budgets and timelines
- Leads a department or functional clinical operations team, evaluating trends across sites and studies to anticipate enrollment, quality, and supply issues
- Directs vendor and CRO performance for assigned studies, escalating issues and driving corrective-action plans to protect deliverables
- Owns the study budget — forecasting, tracking site contracts and payments, and reconciling actuals against plan
- Leads cross-functional study teams (data management, safety, regulatory, supply) and may lead other professionals or junior managers on complex trials
- Manages multiple studies or a therapy-specific division spanning the portfolio, overseeing other Clinical Trial Managers and aligning delivery with program-level strategy and business objectives
- Identifies systemic issues across trials and develops innovative process and technology solutions to improve trial efficiency at scale
- Leads crisis management efforts across studies to ensure swift resolution with minimal impact on quality, budget, and timelines
- Establishes operational policies and standards for vendor/CRO governance, risk management, and monitoring quality across the function
- Engages senior leaders on clinical operations strategy and resourcing, carrying accountability for multi-study budgets that could jeopardize program activities if mismanaged
Level guidelines
The universal leveling rubric applied to this function — how scope, complexity, collaboration, and experience step up across levels.
| Level | Knowledge & Application | Complexity & Problem Solving | Collaboration & Interaction | Typical Degree & Years |
|---|---|---|---|---|
| M1 | Functional expert in clinical trial coordination — GCP, ICH, eTMF/IRB documentation, and visit logistics — applying established practices to supervise a unit's daily work. | Limited scope; resolves routine study-support and documentation issues using established SOPs, escalating protocol or compliance deviations. | Daily interactions with study-team staff, sites, and peer coordinators; first-line contact for the supervised unit. | Functional CTA/CRA expertise with some leadership exposure supervising individual contributors. |
| M2 | Applies deeper clinical operations knowledge across start-up, conduct, and close-out, exercising judgment within known protocol, GCP, and regulatory factors to lead study delivery. | Makes tactical judgments on monitoring quality, site issues, and risk mitigation within established study parameters. | Cross-functional cooperation with data management, safety, regulatory, and vendors; leads a skilled CRA/CTA team. | 2–5 years in clinical team leadership or senior CRA/CTM specialist roles. |
| M3 | Evaluates diverse operational issues and trends across studies, applying clinical operations expertise to manage department deliverables, budgets, and vendor performance. | Diverse issues requiring trend evaluation across sites and studies; develops corrective-action plans and balances quality, budget, and timeline trade-offs. | Leads functional study teams and CRO relationships; may lead managers or cross-functional professionals. | 5–7+ years managing clinical professionals, study budgets, and cross-functional delivery. |
| M4 | Sets operational strategy and standards across multiple studies or a therapy division, aligning clinical operations policy with business and program objectives. | Strategic problems spanning the portfolio — systemic trial issues, crisis management, and innovative process/technology solutions where missteps jeopardize program activities. | Engages senior leaders on functional strategy; oversees multiple CTMs and governs vendor/CRO alliances. | 8–10+ years with complex multi-study or divisional clinical operations leadership. |
Skills
Focus-specific skills the role applies — the relevance layer beyond the occupational base.
- Good Clinical Practice (GCP)
- Non-negotiable regulatory and ethical standard for conducting clinical trials, required at every level.
- ICH guidelines
- International harmonized guidelines governing clinical trial conduct and quality.
- FDA/EMA regulations
- Knowledge of US and European regulatory requirements for clinical research.
- Clinical monitoring and study site management
- Overseeing trial sites, verifying data, and ensuring protocol and regulatory compliance.
- Risk management
- Identifying, tracking, and mitigating operational risks via tools like risk registers.
- Vendor/CRO governance
- Selection, performance management, issue escalation, and quality oversight of CROs and critical vendors.
- Budget and financial accountability
- Managing study and program budgets, ranging up to project budgets of $500MM at director level.
- Cross-functional team leadership
- Aligning and managing teams across functions supporting clinical development.
- People development
- Coaching, training, hiring, and performance management of clinical research staff.
- Portfolio management
- Strategic oversight of multiple trials and programs aligned with corporate objectives.
Provenance
The evidence base behind this profile — every layer is sourced; quality is scored by an adversarial review panel (1–5; passes at ≥4 on the minimum dimension).
8 sources
- O*NET 11-9121.01 (https://www.onetonline.org/link/summary/11-9121.01)
- My Next Move (https://www.mynextmove.org/profile/summary/11-9121.01)
- CareerOneStop (https://www.careeronestop.org/Toolkit/Careers/Occupations/occupation-profile.aspx?keyword=Clinical+Research+Coordinators&location=US&onetcode=11912101)
- ACRP Clinical Research Career Lattice
- SOCRA
- CCRPS
- ZipRecruiter
- MSD job posting
Level — M2 — Manager II
Manages an established team or sub-function; owns planning and performance for the group.
- Scope
- An established team or sub-function
- Autonomy
- Owns planning for the group
- Complexity
- Cross-project coordination and priorities
- Impact
- Group delivery and development
- Decision rights
- Owns staffing, priorities, performance for the group
- Leadership
- Manages a team; sometimes manages leads
- Typical experience
- 5–8 yrs
Adjacent roles
Nearest roles by structural coordinates (level + taxonomy). Distance 0 → 1; each carries its 3-state match band. How coordinates work → · Compare side-by-side →
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O*NET / SOC
- code=11-9111source=jfm-factory.resolve