Senior Clinical Trial Manager – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise and manage the daily operations of various Phase 1–3 clinical trials, encompassing trial initiation, execution, and conclusion.

• Oversee protocol implementation and manage CROs, study service providers, and consultants.

• Set study milestones while tracking and reporting study metrics and timelines to leadership.

• Ensure compliance of trials with ICH GCP, regulations, protocols, and company SOPs.

• Prepare and review essential documents including protocols, informed consent forms, pharmacy and laboratory manuals, monitoring plans, project plans, CRFs, vendor management plans, clinical study reports, and other study documents.

• Create internal tracking and reporting tools, and facilitate meetings for the internal project team.

• Assist with Trial Master File management and readiness for inspections.

• Coordinate the resolution of audit findings and maintain audit-ready documentation for clinical trials.

• Identify, mitigate, and manage risks, including reviewing issues, escalating matters, performing trend analysis, and implementing prevention strategies.

• Support the selection and study-specific training of CRO staff, monitors, investigational sites, and service providers.

• Facilitate study initiation with CROs and clinical sites, including source document worksheets, CRF specifications, clinical site agreements, and related documentation.

• Assist with database locking, clinical study data analysis, and clinical study reporting.

• Ensure prompt responses to queries and monitoring discrepancies.

• Aid in the planning and execution of investigator meetings.

• Participate in cross-functional meetings related to study execution.

• Conduct or coordinate monitoring and co-monitoring visits at clinical sites, CROs, and with vendors.

• Oversee outsourced monitoring and address site-related challenges.

• Track and review protocol deviations, assessing their impact on study data.

• Manage clinical supply forecasting for study drugs and other necessary supplies.

• Potentially manage or supervise junior Clinical Operations staff.

• May assist in the development of Clinical SOPs and department initiatives.

• Travel as required to sites, conferences, and industry meetings.

⛳️ Requirements

• B.A./B.S. degree.

• Over 7 years of clinical research experience in the biotech or a related industry.

• Experience in developing trial plans, with innovative strategies for site monitoring, risk mitigation, trial budgeting, site selection, and clinical supplies management.

• Knowledge of GCP, ICH guidelines, and regulatory requirements pertaining to clinical trial management.

• Understanding and experience with the regulatory framework applicable to interactions with HCPs, payers, advocacy groups, and other business partners.

• Demonstrated leadership abilities to direct protocol execution and to ensure adherence to timeline, budget, and quality metrics.

• Exceptional communication skills.

• Comprehensive clinical research knowledge and a cross-functional understanding of clinical trial methodologies.

• Strong organizational, conflict resolution, prioritization, and negotiation skills.

• Proven capability in creative problem-solving and exercising sound judgment.

• Ability to collaborate effectively with study teams, cross-functional members, and external partners.

• Capacity to manage a high volume of complex tasks within specified timelines.

• Proficient in computer skills, particularly with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.

• Working knowledge of MS Project for developing and updating clinical study timelines.

• Willingness to travel as necessary to sites, conferences, and industry meetings.

• Sedentary work involving repetitive wrist, hand, and finger motions; frequent speaking required.

• Compliance with relevant company policies, protocols, regulations, and ICH GCP standards is essential.

🏝️ Benefits

• Opportunities for career development.

• Access to internal training and attendance at external conferences.

• Commitment to equal employment opportunities.

• 20% travel required.