Project Manager, eCOA

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

📋 Description

• Oversee the planning, setup, monitoring, and closing phases of eCOA studies and programs.

• Collect customer requirements and convert study needs into actionable plans for cross-functional operational teams.

• Develop, maintain, and manage study documentation throughout the project lifecycle.

• Coordinate the distribution, tracking, reconciliation, and management of study devices and related equipment.

• Create, review, and disseminate study status reports, metrics, and project communications.

• Ensure proper archival of study data, documentation, and project records in line with company and regulatory standards.

• Set and manage customer expectations through proactive communication and effective stakeholder engagement.

• Track study timelines, milestones, deliverables, and dependencies to ensure successful project execution.

• Oversee financial aspects of assigned studies, including budget reviews, revenue forecasting, scope change assessments, and invoice reconciliations.

• Identify project risks, formulate mitigation strategies, and appropriately escalate issues to support study success.

• Encourage collaboration among sponsors, vendors, and internal teams to optimize resource use and meet contractual obligations.

• Lead discussions, negotiations, and communications with internal and external stakeholders to facilitate successful study execution.

• Utilize structured problem-solving methodologies to resolve customer concerns and project challenges.

• Maintain issue tracking documentation and ensure prompt follow-up and resolution of customer escalations.

• Act as the Project Management point of contact for operational readiness activities related to new product and service initiatives.

• Present eCOA services and operational workflows during investigator meetings, site initiation meetings, and client presentations as necessary.

• Assist in onboarding, mentoring, and training new members of the Project Management team.

• Contribute to departmental initiatives, process enhancements, and special projects as assigned.

⛳️ Requirements

• Bachelor's degree or an equivalent combination of education and relevant project management experience.

• 4 years of project management experience in pharmaceutical, biotechnology, healthcare, clinical research, life sciences, or related fields.

• Familiarity with the drug development process and the clinical trial environment.

• Preferred experience in supporting technology-enabled clinical trials, eCOA, ePRO, eConsent, RTSM/IRT, or related eClinical solutions.

• Strong skills in project planning, organization, prioritization, and time management.

• Experience in coordinating multiple stakeholders, timelines, budgets, and deliverables concurrently.

• Knowledge of project financial management principles, including budgeting, forecasting, invoicing, and scope management.

• Strong risk management and problem-solving abilities, with a knack for proactively identifying and addressing project challenges.

• Excellent verbal and written communication skills, with the capacity to communicate effectively in English.

• Strong interpersonal abilities and the skill to foster productive relationships with sponsors, sites, and cross-functional teams.

• Proficient in Microsoft Office applications, including Excel, PowerPoint, Word, Outlook, and Teams.

• Willingness to work during US Shift hours (5pm to 2am).

• Detail-oriented with a proven track record of responding promptly to customer inquiries and operational requests.

• PMP certification is preferred.

🏝️ Benefits

• Competitive pay and incentives.

• Provident fund and medical insurance.

• Engaging employee programs and local events.

• Modern office spaces and flexible remote work options.

• Opportunities for professional growth and career advancement within a global organization.