[Hiring] CST Project Manager @Syneos Health

Role Description

Provides customer-focused management of Clinical Surveillance & Training (CST) scoped services to support scientific integrity and data quality in clinical trials. Duties also include liaising with customers, vendors and/or investigative sites to manage projects start-up to final deliverables to the customer. Upon displaying proficiency, a CST Project Manager II may be awarded the opportunity to function at the CST Sr. Project Manager level.

• Function as a representative of the Clinical Surveillance & Training (CST) team on small to large-sized studies or programs.
• Interact with other functional groups, vendors, license holders, Key Opinion Leaders (KOLs), and Sponsors.
• May serve as a Project Lead in CST stand-alone projects and serves as a Functional Lead in full scope or multiple protocol projects.
• Manage CST deliverables pertaining to scoped services vendors (i.e., Rater Training vendors), scale license holders and/or KOLs.
• Manage all aspects of license procurement, scale translation requirements, and paper scale worksheet development.
• Manage creation of all CST service-related documentation and templates.
• Manage development and testing of the CST Study Training and Engagement Portal (STEP) to meet study-specific Rater Training needs.
• Ensure quality and timely delivery and implementation of CST services.
• Develop and maintain the study-specific CST plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Contribute to relevant functional project plans to ensure alignment with the CST plan.
• Provide regular and timely status updates to internal and Sponsor project teams regarding CST scoped services.
• Create and maintain CST metric reports for scoped services, for delivery to client.
• Attend Trusted Process, internal and Sponsor meetings as a lead CST representative.
• Ensure CST project documentation is maintained on an ongoing basis and filed completely and accurately in the Trial Master File (TMF).
• Identify risks and develop mitigation plans as required.
• Participate in Sponsor, internal or agency audits and inspections, as required.
• Responsible for management of CST scope, including identification of CST out of scope activities and overburn.
• Plan, manage, and request CST resources (e.g., CST Project Specialist, CST Clinical Scientist, CST Assessment Scientist, etc).
• Train and mentor internal team members.

Qualifications

• Bachelor’s Degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing or related field preferred.
• Prior experience in study coordination, contract research organization (CRO), pharmaceutical, biotechnology or rater training vendor company preferred.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Good organizational, planning, customer service, and time management skills.
• High level of competency in English language.
• Proficiency with MS Office Applications.
• Strong knowledge of Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines.
• Ability to travel as necessary (up to 25%).

Benefits

• 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.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.