<p>Job Title: Senior Regional Project Manager</p> <p>Job Description</p> <p>We are seeking a Senior Regional Project Manager to join our dynamic BioPharma group. This role involves leading study teams, providing strategic oversight at the US level, and managing day-to-day operations of clinical trials. You will work closely with global teams to ensure study commitments are met and that data is delivered with the highest quality.</p> <p>Responsibilities</p> <ul> <li>Hold overall responsibility for study commitments within the country and ensure timely delivery of data. </li><li>Lead and optimize the performance of the Local Study Team, ensuring compliance with procedural documents, ICH-GCP, and local regulations. </li><li>Perform clinical and operational feasibility assessments for potential studies. </li><li>Coordinate site selection process by conducting site quality risk assessments and qualification visits. </li><li>Ensure timely submissions to IRB and Regulatory Authorities throughout the study duration. </li><li>Prepare and maintain study budgets and agreements, including site budgets and informed consent forms. </li><li>Collect and verify trial essential documents prior to study start and maintain them in compliance with SOPs. </li><li>Plan and coordinate local drug activities, including purchase, reimbursement, and destruction. </li><li>Oversee, manage, and coordinate monitoring activities from site activation to study closure. </li><li>Identify risks and resolve complex study problems proactively. </li><li>Organize regular study team meetings and maintain good relationships with team members and stakeholders. </li><li>Contribute to patient recruitment strategies and communicate regularly with investigators. </li><li>Develop and review risk management plans and coordinate with national investigators as needed. </li><li>Forecast study timelines, resources, budgets, and supplies. </li><li>Ensure systems facilitate critical activities like safety reporting and regulatory submissions. </li><li>Participate in training and coaching of new team members. </li><li>Maintain the eTMF in 'Inspection Ready' status and prepare documents for final archiving. </li><li>Lead activities associated with audits and regulatory inspections. </li><li>Provide process improvement input and regular study updates to line managers. </li><li>Collaborate with local Medical Affairs team and support various SMM initiatives. </li></ul> <p>Essential Skills</p> <ul> <li>5+ years of hands-on project oversight experience. </li><li>2+ years as a Project Manager or CRA. </li><li>2+ years of experience in budget build-out and negotiations. </li><li>Bachelor's degree in a related field. </li><li>Knowledge of ICH-GCP guidelines and relevant local regulations. </li></ul> <p>Pay and Benefits</p> <p>The pay range for this position is $156000.00 - $177000.00/hr.</p> <p>Eligibility requirements apply to some benefits and may depend on your job</p> <p>classification and length of employment. Benefits are subject to change and may be</p> <p>subject to specific elections, plan, or program terms. If eligible, the benefits</p> <p>available for this temporary role may include the following:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a fully remote position.</p> <p>Application Deadline</p> <p>This position is anticipated to close on May 16, 2025.</p> <p>About Actalent</p> <p>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.</p> <p>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.</p> <p>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 actalentaccommodation@actalentservices.com for other accommodation options.</p>