Clinical Project Manager II – Inflammation/ Phase 2b (Sponsor Dedicated/ Remote; Hybrid Foster City, CA Preferred)
About The Position
Syneos Health is a leading fully-integrated life sciences services organization. We partner with innovators across the drug development and commercialization continuum. Our Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and represent them in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. We are passionate about developing our people through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program. We are committed to building an inclusive culture where you can authentically be yourself. Our purpose – Driven to Deliver – captures the passion of our colleagues to shape solutions that can dramatically impact someone’s life. We are continuously building the company we all want to work for and our customers want to work with. By bringing together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
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%).
Nice To Haves
- Hybrid Foster City, CA Preferred
Responsibilities
- US based Regional lead for highly complex Phase 2b studies.
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and 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.
- Lead project team 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.
- May be required to line manage other project management team members and clinical monitoring staff.
Benefits
- company car or car allowance
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- flexible paid time off (PTO) and sick time
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
