Project Role: eCOA Data Specialist

Work Experience: 3+ Years

Work location: Bangalore/Mumbai

Work Mode: Hybrid

Job Overview:

Provide basic and some comprehensive data management expertise to the eCOA Data Management (DM) team to deliver efficient, quality data management products that meet customer needs. Manage the end-to-end delivery of eCOA data management services for multi-service projects approx. 10 studies under the supervision of the Data Team Lead (DTL)/ Sr DTL, or Functional Manager. Ensure quality deliverables are provided on time, meeting customer satisfaction.

Essential Functions:

Undertake eCOA Data Management activities for assigned studies, with/without supervision.
Oversee the setup, implementation, and ongoing management of study data integrations and transfers with appropriate independence as needed.
Ensure all deliverables meet expected quality standards, contractual commitments, customer expectations, and applicable Scope of Work (SOW) requirements.
Manage project progress across assigned studies, proactively identify delivery risks, implement corrective actions, and escalate critical issues to protect timelines and quality.
Collaborate with Line Management, programming teams, and cross-functional stakeholders to support delivery excellence, automation, innovation, and continuous improvement.
Own data cleaning, quality control, and data review activities to maintain data integrity and deliver clean, inspection-ready data to sponsors within agreed timelines.
Maintain compliance with required trainings, eSOPs, study protocols, regulatory expectations, and internal quality requirements.

Qualifications:

Bachelor's degree in pharmacy or equivalent preferred.
3-6 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.
Advanced understanding of the drug development lifecycle and overall clinical research process.

Clinical Data Management Specialist