Posted By:-
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Experience:
yrs -
yrs
Skills :
Salary (Per Hr) :$
Preferred Employment :
Job Description :
The Clinical Trials Manager is responsible for planning, coordinating, and overseeing clinical research studies to ensure they are conducted in compliance with regulatory requirements, sponsor expectations, and organizational standards. This role manages trial timelines, budgets, site performance, documentation, and cross-functional teams to ensure successful trial execution from start-up through close-out.
Clinical Trial Planning & Execution
Manage end-to-end clinical trial activities including study start-up, conduct, monitoring, and close-out.
Develop and maintain clinical trial timelines, work plans, and deliverables.
Coordinate trial feasibility assessments, site selection, and initiation processes.
Ensure study milestones are met within the approved scope, budget, and timelines.
Regulatory & Compliance
Ensure compliance with ICH-GCP guidelines, FDA regulations, IRB requirements, and SOPs.
Support preparation and submission of regulatory documents.
Maintain essential trial documents (TMF/eTMF) and ensure audit readiness.
Participate in audits and inspections (internal/external) and ensure CAPA implementation.
Site & Vendor Management
Oversee site performance and ensure enrollment targets are met.
Manage relationships with investigators, site coordinators, CROs, and vendors.
Monitor vendor deliverables and ensure contract compliance.
Address site issues including deviations, protocol violations, and training gaps.
Team Leadership & Collaboration
Lead cross-functional teams (Clinical Operations, Data Management, Regulatory, Safety, Medical Affairs).
Provide training and guidance to CRAs and clinical research staff.
Conduct regular study team meetings and communicate progress to stakeholders.
Ensure effective communication between sponsors, internal teams, and study sites.
Budget & Resource Management
Assist in clinical trial budgeting, forecasting, and cost tracking.
Ensure efficient allocation of resources and study supplies.
Monitor financial performance and ensure trials stay within budget.
Reporting & Documentation
Prepare clinical trial reports, study status updates, and risk mitigation plans.
Track key performance indicators (KPIs) such as enrollment, monitoring visits, and site compliance.
Ensure timely documentation of adverse events and safety reporting coordination.
Required Qualifications
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or related field.
Minimum 5–8 years of experience in clinical research/clinical trial management.
Strong knowledge of clinical trial regulations (ICH-GCP, FDA, EMA, IRB).
Experience managing multiple studies and cross-functional teams.
Strong organizational, leadership, and project management skills.
Preferred Qualifications
Master’s degree (MBA, MPH, MS Clinical Research, etc.).
Certification such as ACRP-CP, CCRA, CCRP, or SOCRA certification.
Experience working with CROs and global multi-site trials.
Experience in oncology, cardiology, or other therapeutic areas is a plus.
Key Skills & Competencies
Clinical trial project management
Regulatory compliance and audit readiness
Budgeting and forecasting
Risk management and problem-solving
Strong communication and stakeholder management
Vendor and site relationship management
Documentation and reporting skills
Work Environment
Office / hospital / research organization setting.
May require travel to clinical sites (10–30% depending on study needs).
Flexible hours may be required based on study timelines and deadlines.
Reporting To
Director of Clinical Operations / Head of Research / Research Program Manager