Clinical Trial Manager

Actalent; Raleigh (NC); Hybrid; Full time

Job summary

A leading company in clinical and engineering services is seeking a Clinical Trial Manager. This role will entail managing clinical trials, ensuring compliance with regulations, and leading vendor relationships. Successful candidates will have expertise in clinical trial processes and a strong background in oncology or ophthalmology. This position offers a competitive salary and includes medical, dental, and vision benefits in a hybrid work environment.

Benefits

Medical, dental & vision

401(k) Retirement Plan

Short and long-term disability

Qualifications

• Experience in clinical trial management and ICH GCP guidelines.
• Oncology or Ophthalmology experience preferred.
• Proficiency in CTMS tracking systems.

Responsibilities

• Oversee third-party vendors and coordinate responses to audits.
• Manage the planning and execution of investigator meetings.
• Communicate study information effectively to various departments.

Skills

Clinical trial management

Vendor management

Project management

Tools

CTMS tracking systems

Job description

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Job Description

The Clinical Trial Manager is responsible for managing clinical trial studies within specific therapeutic areas. The role involves providing guidance and oversight to project teams for successful study operations, adhering to GCP/ICH Guidelines, regulatory requirements, company SOPs, and study protocols.

Job Title: Clinical Trial Manager

Job Description

The Clinical Trial Manager is responsible for managing clinical trial studies within specific therapeutic areas. The role involves providing guidance and oversight to project teams for successful study operations, adhering to GCP/ICH Guidelines, regulatory requirements, company SOPs, and study protocols.

Responsibilities

• Oversee third-party vendors and coordinate responses to audits.
• Evaluate vendor performance and implement corrective action plans.
• Provide clinical input and develop necessary clinical documents for regulatory submissions.
• Manage the planning and execution of investigator meetings.
• Develop study-specific timelines and coordinate with program timelines.
• Ensure internal functional areas complete deliverables and manage study issues.
• Communicate study information effectively to various departments.
• Identify risks and opportunities in clinical studies and develop mitigation plans.
• Collaborate with Biometry to develop case report forms and data management plans.
• Coordinate with the Manager of Supplies for timely manufacturing and shipping of supplies.
• Work closely with the Manager of Contracts on study budgets and vendor selection.
• Lead meetings with CROs, vendors, and multi-functional teams to ensure quality and timely deliverables.
• Review site and vendor invoices to ensure alignment with project expenses.
• Conduct training for internal staff, CRO staff, vendors, investigators, and study coordinators.
  
  

Essential Skills

• Experience in clinical trial management and ICH GCP guidelines.
• Oncology, Ophthalmology, and/or Biologics experience.
• Recent project management experience supporting sponsors and CROs.
• Strong vendor management skills.
  
  

Additional Skills & Qualifications

• Proficiency in CTMS tracking systems.
• Ability to develop robust data management plans and ensure data integrity.
  
  

Pay and Benefits

The pay range for this position is $57.00 - $71.32/hr.

Eligibility requirements apply to some benefits and may depend on your job

classification and length of employment. Benefits are subject to change and may be

subject to specific elections, plan, or program terms. If eligible, the benefits

Available For This Temporary Role May Include The Following

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

Workplace Type

This is a hybrid position in Raleigh,NC.

Application Deadline

This position is anticipated to close on Jun 27, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [e-mail] for other accommodation options.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Business Consulting and Services

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