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clinical trials manager lead

title: Key Responsibilities and Required Skills for Clinical Trials Manager Lead
salary: $110,000 - $160,000
categories: [Clinical Operations, Clinical Trials, Drug Development, Research]
description: A comprehensive overview of the key responsibilities, required technical skills and professional background for the role of a Clinical Trials Manager Lead.
Comprehensive, SEO-optimized summary of the Clinical Trials Manager Lead role: responsibilities,
required technical and leadership skills, career progression, and education/experience expectations
for recruiting and hiring high-performing clinical operations leaders (ICH-GCP, FDA, CTMS, eTMF).

🎯 Role Definition

The Clinical Trials Manager Lead is a seasoned clinical operations professional who plans, executes, and oversees complex interventional and/or observational clinical studies across multiple sites and regions. This leader drives study start-up, site management, vendor oversight, regulatory compliance, patient safety reporting, budget and timeline management, and cross-functional collaboration to ensure timely, high-quality delivery of clinical programs. This role requires hands-on operational experience, people leadership, strong regulatory knowledge (FDA, EMA, ICH-GCP), and proven ability to optimize processes via CTMS, eTMF and EDC systems.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Senior Clinical Research Associate (Senior CRA) with progressive monitoring, start-up and oversight experience.
  • Clinical Project Manager or Clinical Operations Manager with responsibility for multiple studies.
  • Therapeutic Area Lead with operational experience and cross-functional project leadership.

Advancement To:

  • Director, Clinical Operations
  • Head of Global Clinical Programs / Senior Clinical Program Lead
  • Head of Clinical Development or VP, Clinical Operations

Lateral Moves:

  • Regulatory Affairs Lead / Manager
  • Pharmacovigilance / Safety Lead
  • Clinical Quality Assurance Manager

Core Responsibilities

Primary Functions

  • Lead end-to-end operational planning and execution of phase I–IV clinical trials, including development of study timelines, resource plans, and risk mitigation strategies to meet clinical milestones and regulatory expectations.
  • Serve as the primary clinical operational lead for assigned studies, coordinating cross-functional teams (clinical, regulatory, safety, biostatistics, data management, medical writing, supply chain) to ensure protocol feasibility, alignment, and on-time delivery.
  • Manage study startup activities: lead feasibility assessments, site selection, regulatory/ethics submissions, clinical trial agreements (CTAs), budgeting and payment schedules to accelerate site activation.
  • Oversee site management and monitoring strategy, including on-site and remote monitoring plans, monitoring visit schedules, quality checks, and escalation of protocol deviations or critical findings.
  • Direct vendor selection, contracting and oversight for CROs, central labs, imaging vendors, IVRS/IWRS, and other service providers; negotiate SOWs, drive vendor performance metrics and enforce contractual deliverables.
  • Implement and maintain compliance with GCP, ICH guidelines, national regulations (e.g., FDA, EMA), and company SOPs; lead inspections readiness and remediation activities.
  • Maintain rigorous safety oversight: ensure timely adverse event (AE)/serious adverse event (SAE) reporting, collaborate with Pharmacovigilance for safety signal detection and appropriate regulatory submissions.
  • Own study budgets and financial forecasting: develop and monitor study budgets, site payment plans, track accrual-based costs, and collaborate with finance to manage change orders and variance reporting.
  • Drive enrollment strategy and site performance improvement plans: analyze enrollment metrics, identify bottlenecks, implement targeted site support and recruitment initiatives to hit enrollment targets.
  • Lead and mentor site-facing staff (CRAs, study coordinators) and clinical operations team members: provide coaching, performance management, development plans and workforce planning for study needs.
  • Manage protocol amendments and change control processes, ensuring cross-functional reviews, updated regulatory submissions, site notifications, and training materials are completed accurately and quickly.
  • Ensure clinical data quality and integrity through close collaboration with data management and biostatistics; coordinate data clarification, query resolution, timelines for database locks, and support interim analyses.
  • Maintain and audit the electronic Trial Master File (eTMF) to ensure completeness, accurate metadata, and compliance with inspection standards; coordinate corrective actions for any TMF deficiencies.
  • Lead risk-based monitoring (RBM) or centralized monitoring initiatives: define monitoring triggers, oversee analytics, and adjust monitoring intensity based on quality signals and site performance.
  • Prepare and present regular study status reports and metrics (enrollment, monitoring, TMF completeness, budget burn rate) to senior leadership and steering committees, providing transparent escalation of risks and mitigation plans.
  • Coordinate site training and investigator meetings (virtual or in-person), develop training materials and ensure competency of site staff on protocol procedures and study systems (EDC, ePRO, CTMS).
  • Supervise regulatory documentation for IND/IDE/CTAs and support submissions and responses to health authorities in collaboration with Regulatory Affairs and Medical Affairs.
  • Lead process improvement initiatives to streamline clinical operations: implement best practices, update SOPs, introduce automation where applicable (CTMS workflows, eTMF QC), and measure process KPIs.
  • Manage complex contractual and legal issues in collaboration with Legal and Procurement, including confidentiality agreements, indemnity, IP/technical agreements impacting study conduct.
  • Facilitate cross-functional clinical governance and decision-making forums (study team meetings, weekly stand-ups, escalation committees), driving timely decisions and alignment across stakeholders.
  • Lead readiness and execution of site close-out activities, ensuring final data reconciliation, essential document archiving, TMF completion and financial close.
  • Ensure patient-centricity and ethical conduct across studies by promoting informed consent quality, patient retention strategies, and attention to participant safety and privacy (HIPAA/GDPR where applicable).
  • Support business development and study feasibility assessments by providing operational input, timelines, and resource estimates for new protocols and grant applications.

Secondary Functions

  • Support ad-hoc regulatory or internal audit requests and provide documentation and subject matter expertise for inspections and audits.
  • Contribute to the development and rollout of company-wide clinical operations processes, training programs, and technology adoption (e.g., CTMS, eTMF, EDC integrations).
  • Mentor junior clinical staff and CRAs through formal training, job shadowing, and performance feedback to build bench strength for future clinical leaders.
  • Collaborate with patient engagement and diversity teams to implement inclusive recruitment strategies and improve patient retention and protocol adherence.
  • Participate in cross-functional risk assessments, vendor governance reviews and operational readiness checks for new therapeutic platforms and global/regional launches.

Required Skills & Competencies

Hard Skills (Technical)

  • Proven hands-on expertise in clinical operations for Phase I–IV studies, including start-up, monitoring, close-out and post-approval studies.
  • Deep knowledge of ICH-GCP, FDA, EMA regulations and clinical trial reporting requirements; strong inspection readiness background.
  • Experience with CTMS and eTMF systems (e.g., Veeva, Oracle, Medidata Rave, MasterControl) and EDC platforms; ability to operationalize system workflows.
  • Strong vendor and CRO management skills: contract negotiation, SOW development, KPI/SLA management and performance escalation.
  • Proficient in clinical trial budgeting, forecasting, site payment structures, and variance/burn reporting.
  • Expertise in safety reporting (AE/SAE), coding conventions (MedDRA), and collaboration with pharmacovigilance teams.
  • Ability to design and implement risk-based monitoring strategies and centralized monitoring analytics.
  • Familiarity with regulatory submission processes (IND, CTA, IDE) and preparation of regulatory deliverables and responses.
  • Data literacy: ability to interpret enrollment, monitoring, and data quality metrics; comfortable with dashboards and basic analytics to drive decision-making.
  • Experience leading cross-functional teams and managing stakeholders at all levels, including investigators, KOLs, and executive sponsors.
  • Familiarity with patient-facing platforms (ePRO, eConsent) and decentralized clinical trial (DCT) components is a plus.

Soft Skills

  • Strategic leader with strong decision-making and prioritization skills under tight timelines and ambiguous circumstances.
  • Excellent written and verbal communication, able to synthesize complex clinical status updates for executive stakeholders.
  • Proven ability to influence and negotiate cross-functionally while maintaining collaborative relationships.
  • Strong problem-solving mindset and bias for action — identifies root causes and drives pragmatic solutions.
  • Empathetic people manager and mentor who develops talent and fosters inclusive, high-performing teams.
  • High attention to detail and commitment to quality and regulatory compliance.
  • Adaptable and resilient, comfortable managing competing priorities across multiple studies and geographies.
  • Cultural sensitivity and ability to manage global teams and sites across different regulatory environments.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in life sciences, nursing, pharmacy, public health, or a related field.

Preferred Education:

  • Master’s degree (MPH, MSc Clinical Research, MBA) or advanced clinical degree (RN, PharmD) is highly preferred.

Relevant Fields of Study:

  • Clinical Research / Clinical Trial Management
  • Nursing / Pharmacy / Medicine
  • Life Sciences / Biology / Biotechnology
  • Public Health / Regulatory Science
  • Biostatistics / Health Economics (beneficial)

Experience Requirements

Typical Experience Range: 6–12+ years in clinical research with progressive operational responsibility; 3–5 years leading clinical teams or programs.

Preferred:

  • 8+ years in clinical operations with demonstrated leadership of cross-functional study teams and direct management of CRAs or operations specialists.
  • Prior experience handling global studies (multi-region regulatory submissions) and leading vendor/CRO partnerships.
  • Certifications such as ACRP, SOCRA, PMP, or related clinical research qualifications are advantageous.
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