CST Project Manager – eCOA Manager

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

📋 Description

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

• Collaborate with customers, vendors, and investigative sites from project initiation through to final deliverables.

• Act as a representative of the CST team on studies or programs ranging from small to large scale.

• Engage with functional groups, vendors, license holders, Key Opinion Leaders, and Sponsors.

• Function as Project Lead in standalone CST projects and as Functional Lead in comprehensive or multiple-protocol projects.

• Oversee CST deliverables, license procurement, scale translation requirements, and the creation of paper scale worksheets.

• Manage CST service documentation, templates, and the Study Training and Engagement Portal.

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

• Develop and sustain study-specific CST plans and contribute to functional project plans.

• Provide status updates, recognize delivery risks, and act as a central contact point for CST-related matters.

• Generate and maintain CST metric reports for client delivery.

• Attend internal and Sponsor meetings as a leading CST representative.

• Maintain project documentation and ensure thorough and accurate filing within the Trial Master File.

• Identify risks and formulate mitigation strategies.

• Participate in audits and inspections conducted by Sponsors, internal teams, or agencies.

• Manage CST scope, oversee out-of-scope activities, revenue recognition when assigned, invoice management, and KOL contracts and administration.

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

• Train and mentor internal team members.

⛳️ Requirements

• A 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 (CRO), pharmaceuticals, biotechnology, or rater training vendor companies is preferred.

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

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

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

• Ability to manage time efficiently and work independently.

• High level of proficiency in the English language.

• Competence with MS Office Applications.

• In-depth knowledge of Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other relevant regulatory requirements.

• Willingness to travel as necessary, up to 25% of the time.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when appropriate under the Americans with Disabilities Act.