Sr. Regional Project Manager (LSAD) BioPharma

Senior Regional Project Manager

We are seeking a dedicated and experienced Senior Regional Project Manager to join our dynamic BioPharma group. This role is pivotal in providing strategic oversight and day-to-day management of clinical trials at the US level, collaborating with global teams to ensure successful study execution.

Responsibilities

Assume overall responsibility for study commitments within the US, ensuring timely delivery of high-quality data. Lead and optimize the performance of the Local Study Team, ensuring compliance with procedural documents, ICH-GCP, and local regulations. Conduct clinical and operational feasibility assessments for potential studies. Coordinate the site selection process, including initial Site Quality Risk Assessment and Site Qualification Visits. Ensure timely submission of applications and documents to IRB and Regulatory Authorities. Prepare and maintain accurate study budgets and financial agreements. Oversee monitoring activities from site activation through study closure. Identify and resolve complex study issues and risks. Organize and lead regular Local Study Team meetings. Report study progress to Global Study Leaders and stakeholders. Contribute to patient recruitment strategies and collaborate with investigators. Participate in training and mentoring new team members. Ensure study documents are ready for archiving and regulatory inspections. Provide input for process development and improvement.

Essential Skills

5+ years of hands-on project oversight experience. 2+ years as a Project Manager or Clinical Research Associate. 2+ years of experience in budget build-out and negotiations. Bachelor's degree in a related field. Strong knowledge of ICH-GCP guidelines and local regulations. Excellent project management, team building, and interpersonal skills. Proficiency in spoken and written English.

Additional Skills & Qualifications

Prior experience with Veeva Clinical Vault. Ability to lead and motivate cross-functional teams. Good negotiation skills. Adaptability to work with IT systems. Ability to travel nationally and internationally as required.

Work Environment

This is a remote role with limited to no travel required. All investigator meetings are currently held remotely, with potential occasional in-person meetings. The position offers a supportive work environment with opportunities for professional development and career growth.

Job Type & Location

This is a Contract position based out of Raleigh, NC.

Pay and Benefits

The pay range for this position is $156000.00 - $177000.00 / 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 fully remote position.

Application Deadline : This position is anticipated to close on Nov 13, 2025.

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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.