Clinical Study Manager

Pay: $57-71 an hour

Role Summary

• 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.

Primary Responsibilities

• 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.

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.

Visa sponsorship is not available, now or in the near future, for this position. W2 only – unable to work on c2c.

If you are interested, please respond with your updated resume to ***email_hidden***