Clinical Trial Manager

Overview

Lead and manage clinical trials, overseeing CROs, budgets, and study execution.

Key Responsibilities

• cro selection
• budget management
• study start-up
• patient recruitment
• database testing
• metrics reporting

Tasks

-Oversee relationships with CROs, vendors, field monitors, and other partners; establish and maintain strong relationships with investigators, study coordinators, site personnel, and other external stakeholders. -Work with the Patient Recruitment department to strategize recruitment efforts, meet enrollment projections, and achieve established targets. -Oversee the development of clinical study documents including ICF, monitoring plans, and recruitment plans. -Monitor study status and timelines, providing data for performance metrics reporting. -Participate in database creation, user acceptance testing, and data cleaning activities. -Make primary decisions on CRO and vendor selection alongside the Clinical Program Manager and Director of Clinical Outsourcing. -Develop and manage study budgets and financial reporting, including monthly and quarterly financial reconciliation and forecasting. -Collaborate with the Clinical Program Manager to lead and oversee clinical studies, ensuring timely execution and delivery of key deliverables. -Contribute to SOP development, process mapping, and training of junior CTMs and CTAs. -Coordinate study start-up activities with relevant departments, including feasibility studies and regulatory document preparation. -Work closely with Clinical Outsourcing to select CROs and vendors, manage RFI, RFP, bid defenses, and handle contract and budget negotiations. -Directly manage and supervise CTMs and/or CTAs, conducting performance reviews and supporting their professional development. -Provide study-level updates at management meetings and other forums. -Hands-on involvement in study start-up, patient recruitment, and clinical documentation. -Lead and participate in internal cross-functional clinical team meetings, serving as the main point of contact for study-level status updates.

Requirements

• gcp/ich
• phase i
• trial management
• cro management
• master's degree
• leadership

What You Bring

-Strong knowledge of GCP/ICH guidelines for conducting clinical trials. -Ability to work effectively in a team setting. -Phase I clinical trial experience is advantageous. -Attention to detail and problem-solving capabilities. -Proven experience in clinical trial management, project management, and vendor management. -Experience in neurology, such as narcolepsy, is a plus. -7-10+ years of clinical research experience in pharmaceutical/biotech or CRO settings. -Experience in managing CROs, vendors, budgets, and study timelines. -Excellent leadership, interpersonal, organizational, and multi-tasking skills. -Science or healthcare degree required, with a Master's degree preferred.

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Benefits

-Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Transportation benefits -Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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