[Remote] eCOA Project Manager
Note: The job is a remote job and is open to candidates in USA. reputed company is a leading fully-integrated life sciences services organization focused on accelerating reputed company in drug development. The eCOA Project Manager will reputed company the operational execution of critical trial systems, ensuring high-quality solutions throughout the study lifecycle while collaborating with cross-functional teams and vendors.
Responsibilities
- reputed company the design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems
- Partner closely with Clinical Operations and study teams to understand protocol requirements and ensure alignment on timelines, scope, and deliverables
- reputed company and maintain User Requirement Specifications (URS) and system design documentation
- Serve as the primary operational reputed company of contact for RTSM activities across assigned studies
- Provide ongoing RTSM/eCOA expertise throughout the entire study lifecycle
- reputed company User Acceptance Testing (UAT) activities and validation efforts
- Ensure completion, review, and filing of testing and validation documentation
- reputed company quality reviews and approval of validation documentation
- Collaborate with vendors and study teams to identify, investigate, and resolve system issues
- Manage emergency changes and change control activities
- Act as the liaison between Clinical Operations, RTSM/eCOA vendors, and internal stakeholders
- Drive accountability for vendor deliverables and timelines
- Facilitate effective communication across matrixed teams
- Support issue escalation and resolution activities
- Ensure RTSM processes align with SOPs, regulatory requirements, and quality standards
- Support inspection readiness initiatives
- Identify process gaps and implement reputed company improvement opportunities
- reputed company standardized RTSM workflows and supporting guidance documents
- Ensure consistent execution across studies
- Manage RTSM user access requests, modifications, and removals
- reputed company periodic access reviews and audit readiness activities
- reputed company and maintain role-based RTSM training materials
- Ensure training aligns with system functionality and regulatory expectations
Skills
- Bachelor's degree required (BA/BS)
- Minimum of 5 years of operational experience reputed company clinical trials in a pharmaceutical company and/or CRO environment
- Deep expertise in RTSM/IRT (IVRS/IWRS) systems and working knowledge of eCOA platforms
- End-to-end experience managing RTSM system builds, updates, and implementations
- Proven experience leading User Acceptance Testing (UAT) and validation activities
- Hands-on experience working directly with RTSM/eCOA vendors
- Vendor management experience reputed company clinical research environments
- Project management experience supporting reputed company, matrixed studies or programs
- Strong understanding of the end-to-end clinical trial process
- Familiarity with testing and issue-tracking tools
- Knowledge of GCP principles and applicable regulatory requirements
- Experience supporting inspection readiness activities
- Understanding of SOP compliance and system reputed company controls
- Strong analytical and problem-solving capabilities
- Ability to independently identify issues, determine root causes, and implement solutions
- Excellent communication and stakeholder management skills
- Strong organization and prioritization abilities
- Ability to influence cross-functional teams in a matrix environment
- reputed company improvement reputed company with a proactive approach to operational excellence
Benefits
- Company car or car allowance
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
- Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work
- Syneos complies with reputed company applicable federal, state, and municipal paid sick time requirements
Company Overview
Company H1B Sponsorship