Project Manager, eCOA Manager

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

📋 Description

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

• Collaborate with customers, vendors, and investigative sites from the initiation of projects through to the completion of customer deliverables.

• Represent the CST team in studies or programs ranging from small to large scale.

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

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

• Oversee CST deliverables for scoped-service vendors, scale license holders, and/or KOLs.

• Handle license procurement, scale translation requirements, and the development of paper scale worksheets.

• Manage documentation and templates related to CST services, including the development and testing of the Study Training and Engagement Portal.

• Ensure the quality, timely delivery, and implementation of CST services.

• Create and uphold study-specific CST plans in compliance with SOPs and Work Instructions.

• Contribute to the development of functional project plans.

• Provide status updates to internal and Sponsor project teams, highlighting delivery risks and potential timeline delays.

• Serve as the primary contact for CST-related project issues.

• Generate and maintain CST metric reports for client delivery.

• Represent the CST team in internal and Sponsor meetings as the lead representative.

• Keep project documentation organized and ensure complete and accurate filing in the Trial Master File.

• Identify risks and formulate mitigation plans.

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

• Manage CST scope, out-of-scope activities, overburn, revenue recognition when delegated, invoice management, and/or KOL contracts and oversight.

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

• Train and mentor members of the internal team.

⛳️ 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), pharmaceutical, 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.

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

• Ability to manage time effectively and work independently.

• Proficient level of English language competency.

• Skilled in using 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%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition program.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided when appropriate.