Project Role: eCOA Data Team Lead
Work Experience: 5 + Years
Work location: Bangalore/Mumbai
Work Mode: Hybrid
Job Overview
:Provide strategic leadership and end-to-end ownership of eCOA data management delivery across a portfolio of multi-service studies, ensuring quality, timeliness, budget alignment, and sponsor satisfaction. Lead study planning, execution, risk management, stakeholder communication, milestone delivery, and close-out activities while serving as the Data Team Lead (DTL) and individual contributor across approximately 15-20 studies. Provide expert eCOA DM guidance to cross-functional teams, drive process consistency, support audit readiness, and enable high-quality data management outcomes aligned with customer expectations and regulatory requirements
Essential Functions:
- Lead eCOA study setup activities by gathering stakeholder requirements, documenting data transfer and data cleaning specifications, and ensuring alignment with study objectives and sponsor expectations.
- .Oversee the setup, implementation, and ongoing management of study data integrations and transfers with appropriate independence and escalation as needed.
- Conduct eCOA study close-out activities, including archival, with minimal guidance.
- Own data cleaning, quality control, and data review activities to maintain data integrity and deliver clean, inspection-ready data to sponsors within agreed timelines.
- Ensure all deliverables meet expected quality standards, contractual commitments, customer expectations, and applicable Scope of Work (SOW) requirements.
- Support the training of new joiners.
- Lead internal study meetings, sponsor interactions, study kick-off discussions, and audit-related activities, ensuring clear communication, issue resolution, and stakeholder alignment.
- Manage project progress across assigned studies, proactively identify delivery risks, implement corrective actions, and escalate critical issues to protect timelines and quality.
- Oversee technology updates, database revisions, and process changes, ensuring appropriate impact assessment, implementation oversight, and stakeholder communication.
- Work closely with the programming team for process innovation and automation.
- Maintain compliance with required trainings, eSOPs, study protocols, regulatory expectations, and internal quality requirements.
- .Provide subject matter expertise in the development, revision, and maintenance of core operating procedures, working instructions, and process improvement initiatives.
- Collaborate with Line Management, programming teams, and cross-functional stakeholders to support delivery excellence, automation, innovation, and continuous improvement.
Qualifications:
- Bachelor's or higher degree in Pharmacy or equivalent preferred.
- 5-8 years of direct data management experience, preferably a minimum of 1 year as a CDM project lead. Good to have experience in electronic Clinical Outcome Assessment (eCOA) or Decentralized Clinical Trials (DCT).
- Advanced proficiency in English, both spoken and written. Advanced skills in computer applications like Microsoft Excel, Word, Outlook, etc.
