Clinical Project Manager
hace 1 semana
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Job Responsibilities- Manage projects as a project manager overseeing interdisciplinary clinical research studies and ensure compliance with GCP, relevant SOP's, and regulatory requirements.
- Act 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.
- Lead project teams to ensure quality, timelines, and budget management.
- Accountable for the financial performance of each project.
- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Ensure 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.
- Plan, coordinate, and present at internal and external meetings.
- Prepare project management reports for clients and management.
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- 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.
- 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. Experience in global trial project management and 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%).
At Syneos Health, 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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
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