Sr. Clinical Project Manager

We are seeking a dedicated and experienced Sr. Regional Project Manager to join our team within the BioPharma group. The successful candidate will manage and lead Local Study Teams (LSTs) to ensure the delivery of country-level study commitments, adhering to agreed budgets, timelines, and resources. This role requires compliance with international guidelines such as ICH-GCP and relevant local regulations.

• Hold overall responsibility for fulfilling country-level study commitments and ensuring timely, high-quality data delivery.
• Lead Local Study Teams, fostering collaboration and high performance.
• Drive optimal performance and compliance of teams with procedural documents, ICH-GCP requirements, and local regulations.
• Coordinate site selection process, identifying potential sites and investigators.
• Ensure timely submission of required applications and documentation to Ethics Committees/IRBs.
• Prepare accurate country-level financial agreements and maintain study budgets.
• Manage and coordinate all monitoring activities from site activation to closure.
• Conduct co-monitoring visits and training visits with study CRAs.
• Identify risks and facilitate the resolution of complex study problems.
• Organize and lead regular Local Study Team meetings.
• Report study progress and updates to relevant stakeholders.
• Contribute to patient recruitment strategies and maintain contact with investigators.
• Coordinate with National Coordinating Investigator on recruitment and study matters.
• Plan and lead National Investigator Meetings as needed.
• Assist with forecasting for study timelines, resources, and budgets.
• Ensure accuracy and compliance of all study payments.
• Participate in the training and coaching of new team members.
• Maintain the study eTMF in an 'Inspection Ready' state.
• Plan and lead audit and regulatory inspection activities.
• Contribute insights for process development and improvement.
• Ensure full compliance with local policies, codes of ethics, and business practices.
• Collaborate with the local Medical Affairs team for optimal study delivery.

• Minimum of 5 years of hands-on project management experience.
• 2+ years of budgeting experience, managing project budgets and reallocating funds.
• Experience in Biopharma therapeutic areas such as Respiratory, Infectious Disease, CV, Renal, and Metabolism.
• Strong leadership and team management skills.
• Proficiency in ICH-GCP guidelines and relevant local regulations.
• Excellent verbal and written English communication skills.

• CRA experience is preferred but not required.
• Experience with sponsor oversight of in-house studies.
• Good negotiation skills.
• Ability to learn and adapt to IT systems.
• Ability to travel nationally and internationally as required.

This is a remote role with limited to no travel required. Occasionally, there may be a need to attend Investigator Meetings, but currently, all meetings are held remotely. The work environment supports career building and development, offering a range of benefits including PTO, holidays, and partner discounts.

This is a Contract position based out of Wilmington, DE.

The pay range for this position is $155000.00 - $165000.00/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)

This is a fully remote position.

This position is anticipated to close on Mar 27, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.