Project Manager, eCOA

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2019-10

Healthcare • Consulting • Logistics

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• Lead the planning, setup, monitoring, and closeout phases of eCOA studies and programs. • Gather customer requirements and translate 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 associated equipment. • Create, review, and distribute study status reports, metrics, and project communications. • Ensure appropriate archival of study data, documentation, and project records in accordance with company and regulatory requirements. • Establish and manage customer expectations through proactive communication and effective stakeholder engagement. • Monitor study timelines, milestones, deliverables, and dependencies to ensure successful project execution. • Manage financial aspects of assigned studies, including budget reviews, revenue forecasting, scope change assessments, and invoice reconciliation activities. • Identify project risks, develop mitigation strategies, and escalate issues appropriately to support study success. • Facilitate collaboration between sponsors, vendors, and internal teams to drive efficient use of resources and achievement of contractual obligations. • Lead internal and external discussions, negotiations, and stakeholder communications to support successful study execution. • Apply structured problem-solving methodologies to address customer concerns and project challenges. • Maintain issue tracking documentation and ensure timely follow-up and resolution of customer escalations. • Serve 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 required. • Support onboarding, mentoring, and training of new Project Management team members. • Contribute to departmental initiatives, process improvements, and special projects as assigned.

🎯 Requirements

• Bachelor's degree or equivalent combination of education and relevant project management experience. • 4 years of project management experience within pharmaceutical, biotechnology, healthcare, clinical research, life sciences, or related industries. • Understanding of the drug development process and clinical trial environment. • Experience supporting technology-enabled clinical trials, eCOA, ePRO, eConsent, RTSM/IRT, or related eClinical solutions is preferred. • Strong project planning, organization, prioritization, and time management skills. • Experience coordinating multiple stakeholders, timelines, budgets, and deliverables simultaneously. • Knowledge of project financial management concepts, including budgeting, forecasting, invoicing, and scope management. • Strong risk management and problem-solving skills with the ability to proactively identify and address project challenges. • Excellent verbal and written communication skills with the ability to communicate effectively in English. • Strong interpersonal skills and the ability to build productive relationships with sponsors, sites, and cross-functional teams. • Working knowledge of Microsoft Office applications, including Excel, PowerPoint, Word, Outlook, and Teams. • Willingness to work in US Shift (5pm to 2am). • Detail-oriented with demonstrated responsiveness to customer inquiries and operational requests. • PMP certification preferred.

🏖️ Benefits

• Competitive pay and incentives. • Provident fund and medical insurance. • Engaging employee programs and local events. • Modern office spaces and remote work flexibility. • Opportunities for professional growth and career development within a global organization.

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