Project Manager

• 10+ years of experience in Clinical Data Management, including roles as CDM, Sr. CDM, and/or Project Manager.
• Proven experience in eClinical and eCOA implementation across global clinical trials.
• Strong command of EDC systems such as Medidata Rave, Oracle InForm, and Veeva Vault.
• Familiarity with data standards (CDISC, SDTM), medical coding (MedDRA, WHO Drug), and regulatory compliance.
• Demonstrated ability to lead studies independently, manage complex timelines, and coordinate with global stakeholders.
• Experience in specialty data functions such as pharmacovigilance, IRT, and lab data oversight.
• Excellent communication, leadership, and problem-solving skills.
• PMP certification is highly desirable.

• Lead end-to-end implementation of eClinical technologies, with a strong focus on eCOA platforms, ensuring alignment with study timelines and regulatory requirements.
• Coordinate cross-functional teams, including clinical operations, data management, programming, pharmacovigilance, and external vendors.
• Act as the primary point of contact for sponsors, overseeing all aspects of study delivery, stakeholder communication, and issue resolution.
• Manage device logistics, including provisioning, tracking, and troubleshooting of mobile devices used in clinical trials.
• Oversee data integration processes, ensuring consistency across systems (e.g., EDC, IRT, eCOA, lab platforms).
• Ensure compliance with GCP, ICH, CDISC standards (SDTM), and data privacy regulations throughout the project lifecycle.
• Identify risks proactively, propose mitigation strategies, and deliver executive-level reporting on project status, metrics, and budget tracking.
• Support database lock readiness, including oversight of data cleaning, query resolution, and external data reconciliation (e.g., labs, imaging, SAE).
• Mentor and guide junior CDMs, fostering team development and ensuring high-quality deliverables.

Capgemini