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CST Project Manager, eCOA Manager
Syneos Health. Provide customer-focused management of Clinical Surveillance & Training (CST) scoped services supporting scientific integrity and data quality in clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Surveillance and Training management, ensuring scientific integrity and data quality in clinical trials. Proficient in project leadership, stakeholder engagement, and compliance with Good Clinical Practice and regulatory guidelines.
Highest-signal resume keywords
Clinical Surveillance ManagementProject LeadershipGood Clinical Practice (GCP)Study CoordinationMS Office Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study Training DevelopmentMetric ReportingRisk ManagementDocumentation ManagementTemplate Development
Soft Skills
Excellent CommunicationInterpersonal SkillsOrganizational SkillsTime ManagementAbility to Multitask
Tools & Technologies
Study Training and Engagement Portal (STEP)Trial Master File
Industry Keywords
Contract Research Organization (CRO)PharmaceuticalBiotechnologyRater TrainingInternational Conference on Harmonization (ICH)
About the role
Key responsibilities & impact- Provide customer-focused management of Clinical Surveillance & Training (CST) scoped services supporting scientific integrity and data quality in clinical trials
- Liaise with customers, vendors, and investigative sites from project start-up through final customer deliverables
- Represent the CST team on small to large-sized studies or programs and interact with functional groups, vendors, license holders, Key Opinion Leaders, and Sponsors
- Serve as Project Lead for CST stand-alone projects and Functional Lead for full-scope or multiple-protocol projects
- Manage CST deliverables, license procurement, scale translation requirements, and paper scale worksheet development
- Manage creation of CST service documentation and templates, including development and testing of the Study Training and Engagement Portal (STEP)
- Ensure quality, timely delivery, and implementation of CST services
- Develop and maintain study-specific CST plans in accordance with SOPs and Work Instructions
- Contribute to functional project plans and provide status updates, risks, and issue management to internal and Sponsor project teams
- Create and maintain CST metric reports for client delivery
- Attend internal and Sponsor meetings as lead CST representative
- Maintain project documentation and ensure complete and accurate filing in the Trial Master File
- Identify risks and develop mitigation plans
- Participate in Sponsor, internal, or agency audits and inspections
- Manage CST scope, out-of-scope activities, overburn, revenue recognition when delegated, invoice tracking, payment confirmation, and KOL contracts and management
- Plan, manage, and request CST resources and provide resource updates
- Train and mentor internal team members
Requirements
What you’ll need- Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
- Prior experience in study coordination, contract research organization (CRO), pharmaceutical, biotechnology or rater training vendor company preferred
- Excellent written and spoken communication, presentation, and interpersonal skills
- Ability to inform, influence, convince and persuade
- Good organizational, planning, customer service, and time management skills
- Ability to multitask under tight deadlines while maintaining attention to detail
- Ability to manage time and work independently
- 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 as necessary, up to 25%
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate