[Remote] eCOA Project Manager

Note: The job is a remote job and is open to candidates in USA. Syneos Health is a leading fully-integrated life sciences services organization focused on accelerating customer success in drug development. The eCOA Project Manager will lead the operational execution of critical trial systems, ensuring high-quality solutions throughout the study lifecycle while collaborating with cross-functional teams and vendors.ResponsibilitiesLead the design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systemsPartner closely with Clinical Operations and study teams to understand protocol requirements and ensure alignment on timelines, scope, and deliverablesDevelop and maintain User Requirement Specifications (URS) and system design documentationServe as the primary operational point of contact for RTSM activities across assigned studiesProvide ongoing RTSM/eCOA expertise throughout the entire study lifecycleLead User Acceptance Testing (UAT) activities and validation effortsEnsure completion, review, and filing of testing and validation documentationOversee quality reviews and approval of validation documentationCollaborate with vendors and study teams to identify, investigate, and resolve system issuesManage emergency changes and change control activitiesAct as the liaison between Clinical Operations, RTSM/eCOA vendors, and internal stakeholdersDrive accountability for vendor deliverables and timelinesFacilitate effective communication across matrixed teamsSupport issue escalation and resolution activitiesEnsure RTSM processes align with SOPs, regulatory requirements, and quality standardsSupport inspection readiness initiativesIdentify process gaps and implement continuous improvement opportunitiesDevelop standardized RTSM workflows and supporting guidance documentsEnsure consistent execution across studiesManage RTSM user access requests, modifications, and removalsOversee periodic access reviews and audit readiness activitiesDevelop and maintain role-based RTSM training materialsEnsure training aligns with system functionality and regulatory expectationsSkillsBachelor's degree required (BA/BS)Minimum of 5 years of operational experience within clinical trials in a pharmaceutical company and/or CRO environmentDeep expertise in RTSM/IRT (IVRS/IWRS) systems and working knowledge of eCOA platformsEnd-to-end experience managing RTSM system builds, updates, and implementationsProven experience leading User Acceptance Testing (UAT) and validation activitiesHands-on experience working directly with RTSM/eCOA vendorsVendor management experience within clinical research environmentsProject management experience supporting complex, matrixed studies or programsStrong understanding of the end-to-end clinical trial processFamiliarity with testing and issue-tracking toolsKnowledge of GCP principles and applicable regulatory requirementsExperience supporting inspection readiness activitiesUnderstanding of SOP compliance and system security controlsStrong analytical and problem-solving capabilitiesAbility to independently identify issues, determine root causes, and implement solutionsExcellent communication and stakeholder management skillsStrong organization and prioritization abilitiesAbility to influence cross-functional teams in a matrix environmentContinuous improvement mindset with a proactive approach to operational excellenceBenefitsCompany car or car allowanceHealth benefits to include Medical, Dental and VisionCompany match 401kEligibility to participate in Employee Stock Purchase PlanEligibility to earn commissions/bonus based on company and individual performanceFlexible paid time off (PTO) and sick timeBecause certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you workSyneos complies with all applicable federal, state, and municipal paid sick time requirementsCompany OverviewSyneos Health, the only fully integrated end-to-end clinical and commercial solution organization. It was founded in 1985, and is headquartered in Morrisville, North Carolina, USA, with a workforce of 10001+ employees. Its website is https://www.syneoshealth.com/.Company H1B SponsorshipSyneos Health has a track record of offering H1B sponsorships, with 4 in 2026, 35 in 2025, 26 in 2024, 49 in 2023, 63 in 2022, 84 in 2021, 63 in 2020. Please note that this does not guarantee sponsorship for this specific role.