Associate eCOA Manager

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

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

• Ensure accountability for deliverables, timelines, and completion of tasks in accordance with Worldwide SOP standards.

• Analyze study trends and proactively address specific study requirements with eCOA vendors and study teams.

• Relay eCOA project activity updates to internal and sponsor study teams.

• Act as the primary escalation point for any project-related issues concerning assigned eCOA studies.

• Manage the timely dissemination of eCOA project communications, which includes study status reports, meeting agendas, minutes, and scheduling project calls.

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

• Prepare, review, and approve site materials as well as helpdesk documentation when necessary.

• Conduct financial reviews and oversee budgets, including the review of Change Orders.

• Collaborate effectively with eCOA vendors, study teams, stakeholders, and sponsors.

⛳️ Requirements

• A degree in a relevant field or equivalent experience is required.

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

• A minimum of 1 year in project management is required.

• Strong leadership skills and a thorough understanding of policies, procedures, financial principles, and leadership strategies.

• Exceptional time management and project management abilities.

• Strong communication skills.

• Proven knowledge of the operational aspects of Phase I-IV clinical research trials.

• Familiarity with the Software Development Life Cycle (SDLC).

• Knowledge of eCOA topics, including designs and scales.

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

• Proficiency in English for writing, speaking, and comprehension in day-to-day business interactions.

• Strong client-facing capabilities.

• Proficient in common office software applications.

• Self-motivated with a positive contribution to team dynamics.

• High level of attention to detail.

• Ability to prioritize and manage multiple projects concurrently.

• Capacity to exercise sound independent judgment and take initiative.

• Ability to make effective decisions in a fast-paced, dynamic environment.

• Adaptability to new technologies, concepts, and processes; ability to implement improvements and resolve issues.

• Highly organized, detail-oriented, and service-minded.

• Role may involve domestic and international travel.

• Flexibility to work across various time zones as needed.

🏝️ Benefits

• A competitive benefits package tailored to the location.

• Opportunities for mentorship and professional training.

• Potential for promotions and internal advancement.

• An inclusive and equitable workplace environment.

• Transparent compensation structures and pay equity.

• Possibility of travel to participate in key meetings.