Clinical Data Management Specialist

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.

Skills Required
Microsoft Excel, Data Cleaning, Data Review, Quality Control