About This Role:

About This Role:

We are seeking a highly experienced and motivated Sr. Clinical Research Project Manager (Sr. CRPM) to oversee the planning, execution, and completion of complex clinical research projects. The Sr. CRPM will be responsible for leading cross-functional teams, managing study budgets and timelines, and ensuring that studies are conducted in compliance with regulatory requirements and guidelines, including Good Clinical Practice (GCP) guidelines.

Essential Duties and Responsibilities:

• Lead the planning, execution, and oversight of all domestic and international clinical research types (i.e., Sponsor-initiated, Research as a Service (RaaS) and Investigator-initiated (IIR) studies), including coordinating the activities of cross-functional teams, ensuring compliance with protocols and standard operating procedures, and monitoring progress against project timelines and budgets.
• Develop and review study-related documents, such as protocols, informed consent forms, case report forms, and study manuals.
• Lead study start-up activities, including site identification, feasibility assessment, and study initiation visits.
• Travel up to 10% of the time to support project- and role-specific activities.
• Manage study vendors, including clinical research organizations (CROs) and other external service providers, to ensure that services are provided in a timely and cost-effective manner.
• Manage study monitors and provide guidance and support as needed.
• Develop and maintain relationships with key stakeholders, including study coordinators, investigators, and sponsor representatives.
• Ensure that studies are conducted in compliance with regulatory requirements and guidelines, including GCP guidelines.
• Manage study budgets and timelines, including forecasting and tracking expenses and negotiating study contracts.
• Develop risk management plans and mitigation strategies.
• Develop and implement quality control measures to ensure the accuracy and completeness of study data.
• Prepare study reports, presentations, and publications.
• Mentor and train junior staff members.

Experience and Minimum Qualifications:

• Bachelor's degree in a health-related field or relevant work experience in clinical research.
• 8+ years of experience in clinical research project management or related field, with a proven track record of managing complex clinical research projects.

Knowledge, Skills and Abilities:

• In-depth knowledge of regulatory requirements and Good Clinical Practice (GCP) guidelines. Experience with ISO 14155 and other international guidelines desirable, but not required.
• Excellent organizational, communication, and problem-solving skills, with the ability to prioritize and multitask effectively.
• Strong attention to detail and accuracy.
• Proficiency with Microsoft Office Suite and experience with electronic data capture systems and clinical trial management systems.
• Ability to lead cross-functional teams and work effectively in a fast-paced, deadline-driven environment.
• Experience with clinical trial budgets and financial management.
• Strong leadership skills, with the ability to mentor and train junior staff members.
• Willingness to learn and take on new challenges.

Work Environment / Other Requirements:

This is a full-time, fully remote position that may require occasional evening or weekend work. The Sr. Clinical Research Project Manager will report to the Manager, Clinical Research Projects and work closely with the entire clinical research team. There are occasions where you may be asked to travel to team offsite events, conferences, or in the execution of your job. Travel may be international.

What's In It for You:

A job that doesn't feel like a job, working with an impressive group that feels more like friends than colleagues who are highly collaborative and supportive.

Location:
Remote - US

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range
$115,000.00 - $149,000.00