Associate eCOA Manager

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

📋 Description

• Provide oversight for project management from maintenance stages through to eCOA decommissioning.

• Supervise deliverables, timelines, and the completion of work in accordance with Worldwide SOP standards.

• Assess and identify study trends while proactively addressing study-specific requirements in collaboration with eCOA vendors and study teams.

• Relay eCOA project activities to both internal and sponsor study teams.

• Act as the escalation point for any project issues related to assigned eCOA studies.

• Coordinate the timely distribution of study status reports, meeting agendas, meeting minutes, and project calls.

• Evaluate study designs and approve User Requirements Specifications (URS) for changes in scope after go-live.

• Prepare, review, and authorize site, support, and helpdesk documentation.

• Conduct financial reviews and manage budgets, including reviewing Change Orders.

⛳️ Requirements

• Must possess a degree in a relevant field or demonstrate equivalent experience.

• At least 1 year of experience in eCOA and clinical trials is required.

• Minimum of 1 year of experience in project management is essential.

• Experience in a Contract Research Organization (CRO) or pharmaceutical setting is mandatory.

• Proven knowledge of operational elements related to Phase I-IV clinical research trials.

• Understanding of the Software Development Life Cycle (SDLC) is necessary.

• Familiarity with eCOA topics, including eCOA designs and scales, is preferred.

• Proficiency in English is required for daily business operations.

• Strong client-facing skills are essential.

• Competence in common office software is expected.

• Ability to prioritize and manage multiple projects simultaneously is crucial.

• Exceptional project management skills are a must.

• Willingness and ability to travel both domestically and internationally are required.

• Flexibility to work across various time zones when necessary.

🏝️ Benefits

• Competitive benefits package that varies by location.

• Transparent compensation and commitment to pay equity.

• Access to mentorship and training opportunities.

• Potential for promotions and internal career growth.

• An inclusive and equitable workplace environment.

• Opportunities for both domestic and international travel.