Clinical Project Manager – Regional or Global Experience
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Job Description
Clinical Project Manager overseeing interdisciplinary clinical research studies at Syneos Health. Ensuring compliance with regulations and managing project deliverables effectively.
Responsibilities:
- Manages a project as a project manager overseeing interdisciplinary clinical research studies.
- Ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
- Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
- Leads project team to ensure quality, timelines and budget management.
- Accountable for the financial performance of each project.
- Coordinates activities and deliverables of all study conduct partners and proactively identifies and manages issues.
- Ensures studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
- Accountable for all project deliverables for each project assigned.
- Responsible for quality and completeness of TMF for assigned projects.
- Accountable for maintenance of study information on a variety of databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct.
- Oversight for development and implementation of project plans.
- Plans, coordinates and presents at internal and external meetings.
- Prepares project management reports for clients and management.
- Develops strong relationships with current clients to generate new and/or add-on business for the future.
- May participate in bid defense meetings where presented as potential project manager.
Requirements:
- Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
- Clinical research organization (CRO) and relevant therapeutic experience preferred.
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills.
- Strong ability to manage time and work independently.
- Direct therapeutic area expertise.
- Ability to embrace new technologies.
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- Ability to travel as necessary (approximately 25%).
Benefits:
- We are passionate about developing our people, through career development and progression;
- supportive and engaged line management;
- technical and therapeutic area training;
- peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
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