Description
Syneos Health is seeking a CST Project Manager (eCOA Manager) to work remotely in several EMEA countries.
The successful candidate will provide customer-focused management of Clinical Surveillance & Training (CST) scoped services to support scientific integrity and data quality in clinical trials.
Key Responsibilities:
- Manage CST deliverables pertaining to scoped services vendors, scale license holders, and/or Key Opinion Leaders (KOLs)
- Develop and maintain study-specific CST plans in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- 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
- Attend Trusted Process, internal, and Sponsor meetings as a lead CST representative
- Ensure CST project documentation is maintained 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
- Manage CST scope, including identification of CST out-of-scope activities and overburn
- Plan, manage, and request CST resources
- Train and mentor internal team members
Requirements:
- Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field
- Prior experience in study coordination, contract research organization (CRO), pharmaceutical, biotechnology, or rater training vendor company
- Excellent communication, presentation, and interpersonal skills
- 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 and other applicable regulatory requirements
- Ability to travel up to 25%
What We Offer:
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture