Required Knowledge, Skills, and Abilities
Strong knowledge of clinical trial operations from study start-up through close-out.
Thorough understanding of ICH/GCP guidelines, regulatory requirements, study protocols, and SOPs.
Experience managing CROs, vendors, study timelines, risks, and cross-functional teams.
Strong analytical, problem-solving, and decision-making skills.
Excellent written, verbal, organizational, and interpersonal communication skills.
Ability to manage multiple priorities while working independently and collaboratively.
Proficiency with CTMS, eTMF, EDC, Microsoft Office, and other clinical trial systems.
Education & Experience
Bachelor's degree in Life Sciences, Health Sciences, or a related field preferred; equivalent experience may be considered.
Minimum of 8 years of clinical research experience.
Minimum of 2 years of clinical study management, clinical operations, or related experience.
Experience working with CROs, vendors, clinical sites, and cross-functional study teams.
Sponsor-side experience with vendor oversight, TMF management, inspection readiness, and clinical study documentation preferred.
Manage day-to-day clinical study activities from study start-up through close-out.
Coordinate study activities with internal teams, CROs, vendors, investigators, and study coordinators.
Monitor essential document collection, site activation, clinical supply release, and study tracking activities.
Lead or participate in study meetings to review progress, timelines, risks, issues, and action items.
Track study milestones and implement mitigation plans to address operational risks and delays.
Support vendor selection activities, including RFP development, scopes of work, budgets, and planning documents.
Oversee CRO and vendor performance and resolve operational issues through timely escalation and follow-up.
Develop and implement corrective and preventive action (CAPA) plans as needed.
Coordinate and verify study-specific training for CRO staff, vendors, investigators, and site personnel.
Monitor vendor qualifications, training documentation, staffing changes, and performance against KPIs.
Manage Trial Master File (TMF) quality, reconciliation, filing, and quality control activities.
Draft, review, and approve study documents, including informed consent forms, manuals, monitoring plans, and monitoring reports.
Review audit findings, monitoring observations, and study conduct issues to ensure appropriate resolution.
Provide operational support and guidance to study sites, CROs, vendors, IRBs/ECs, and internal stakeholders.
Maintain inspection readiness and ensure compliance with applicable regulations and company procedures.
Oversee CTMS updates and study status reporting throughout the study lifecycle.
Review clinical data, vendor reports, monitoring trends, and data listings to support data integrity and GCP compliance.
Contribute to case report form development, data management plans, data transfer plans, and clinical data review.
Collaborate with Data Management, Safety, Regulatory, Clinical Supplies, Contracts, and Biostatistics to support study execution.
Prepare study status reports summarizing progress, risks, issues, action items, and delegated responsibilities.
Support study, site, and vendor budget development and financial planning.
Review site and vendor invoices for compliance with approved budgets and contractual agreements.
Support investigator budgets, vendor contracts, scopes of work, and financial tracking.
Perform additional duties as assigned.
Provide operational leadership, coordination, and oversight for assigned clinical studies.
Ensure studies are conducted in compliance with ICH/GCP guidelines, regulatory requirements, company SOPs, study protocols, and study-specific plans.
Partner with cross-functional teams, CROs, vendors, investigators, and study sites to deliver high-quality studies on time and within scope.