CST Project Manager, eCOA Manager

🔥 6 minutes ago

🇪🇺 Europe – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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

• 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

• 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