CST Project Manager, eCOA Manager

This is a fully remote position, open to applicants in Europe.

📋 Description

• Deliver customer-centric management of Clinical Surveillance & Training (CST) scoped services that uphold scientific integrity and data quality in clinical trials.

• Collaborate with customers, vendors, and investigative sites from the initiation of the project to the final delivery to clients.

• Represent the CST team on studies or programs ranging from small to large-scale, engaging with functional groups, vendors, license holders, Key Opinion Leaders, and Sponsors.

• Act as Project Lead for CST stand-alone initiatives and Functional Lead for comprehensive or multiple-protocol projects.

• Oversee CST deliverables, license procurement, translation requirements for scaling, and development of paper scale worksheets.

• Manage the creation of CST service documentation and templates, including the development and testing of the Study Training and Engagement Portal (STEP).

• Ensure high-quality, timely delivery, and execution of CST services.

• Develop and uphold study-specific CST plans in line with SOPs and Work Instructions.

• Contribute to functional project plans and provide updates on status, risks, and issue management to both internal and Sponsor project teams.

• Generate and maintain CST metric reports for client delivery.

• Participate in internal and Sponsor meetings as the primary CST representative.

• Maintain project documentation and guarantee complete and accurate filing in the Trial Master File.

• Identify potential risks and formulate mitigation strategies.

• Engage in Sponsor, internal, or agency audits and inspections.

• Manage CST scope, out-of-scope tasks, overburn, revenue recognition (when designated), invoice tracking, payment confirmation, and management of KOL contracts.

• Plan, oversee, and request CST resources while providing updates on resource availability.

• Train and mentor members of the internal team.

⛳️ Requirements

• Bachelor's Degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing, or a related field is preferred.

• Previous experience in study coordination, contract research organizations (CROs), pharmaceutical, biotechnology, or rater training vendor companies is preferred.

• Exceptional written and verbal communication, presentation, and interpersonal skills.

• Capability to inform, influence, convince, and persuade others.

• Strong organizational, planning, customer service, and time management abilities.

• Capacity to multitask under tight deadlines while maintaining a keen attention to detail.

• Ability to manage time effectively and work independently.

• High proficiency in the English language.

• Competency in MS Office Applications.

• Solid understanding of Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other relevant regulatory requirements.

• Willingness to travel as necessary, up to 25%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition programs.

• Comprehensive total rewards program.

• An inclusive culture.

• Reasonable accommodations when appropriate.