eCOA Data Team Lead

IQVIA India

Bengaluru

On-site

INR 1,800,000 - 3,000,000

Full time

46 hours ago
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Job summary

IQVIA India is seeking a Data Team Lead to provide strategic leadership and end-to-end ownership of eCOA data management across multiple studies, ensuring quality, timeliness, budget alignment, and sponsor satisfaction.

You will oversee study planning, data integrations, cleaning, QC, audit readiness, and regulatory compliance, while mentoring new joiners and coordinating with programming and cross-functional teams. This role spans approximately 15-20 studies in a dynamic environment.

Qualifications

  • 5-8 years of direct data management experience, including at least 1 year as a CDM project lead.
  • Experience with eCOA or Decentralized Clinical Trials (DCT) is desirable.
  • Proficient in English (spoken and written) and office productivity tools.

Responsibilities

  • 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 escalation as needed.
  • 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.

Skills

eCOA DM
Data Management
CDM Project Lead
Stakeholder management
Process improvement
Audit readiness
Training delivery

Education

Bachelor's in Pharmacy

Tools

Microsoft Excel
Microsoft Word
Outlook

Job description

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 Function's:
  • 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 escalation as needed.
  • 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.
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