eCOA Project Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $114k - $210.9k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Lead 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 • Develop and maintain User Requirement Specifications (URS) and system design documentation • Serve as the primary operational point of contact for RTSM activities across assigned studies • Provide ongoing RTSM/eCOA expertise throughout the entire study lifecycle • Lead User Acceptance Testing (UAT) activities and validation efforts • Ensure completion, review, and filing of testing and validation documentation • Oversee 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 continuous improvement opportunities • Develop standardized RTSM workflows and supporting guidance documents • Ensure consistent execution across studies • Manage RTSM user access requests, modifications, and removals • Oversee periodic access reviews and audit readiness activities • Develop and maintain role-based RTSM training materials • Ensure training aligns with system functionality and regulatory expectations

🎯 Requirements

• Bachelor's degree required (BA/BS) • Minimum of 5 years of operational experience within 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 within clinical research environments • Project management experience supporting complex, 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 security controls

🏖️ Benefits

• 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 • Company car or car allowance