Job Title: Data Manager (Level III)

Lifelancer is seeking a highly skilled Data Manager (Level III) to join our team. This role requires a dynamic professional adept at managing all aspects of data management for assigned projects from initial setup to database lock. If you have a passion for data management and meet the qualifications below, we encourage you to apply.

Key Responsibilities

• Serve as the Lead Data Manager on assigned projects, interfacing directly with clients.
• Effectively manage all data management aspects of assigned projects from setup to database lock.
• Attend regular meetings with Sponsors and project teams to discuss data management issues and provide status updates.
• Participate in internal and external training courses as required.
• Adhere strictly to SOPs, ICH-GCP guidelines, and other regulatory standards.
• Prepare and review Data Management process control documents, including Data Management Plans, Data Quality Check Specifications, and more.
• Coordinate and manage EDC access and training for investigators and other team members.
• Review, freeze, and lock data per Data Management documents to ensure accuracy and consistency.
• Conduct ongoing quality control and data review.
• Participate in eTMF audits and respond promptly to auditor comments.
• Produce and coordinate reports and listings for team reviews and DSMBs as specified in client contracts.
• Coordinate with Medical Data Reviewer and Monitor for medical terminology coding.
• Develop and finalize third-party transfer specifications for electronic databases.
• Maintain audit-ready Data Management study documentation on SharePoint.
• Respond to QC comments promptly in conjunction with the Data Project Manager/Oversight Director.
• Perform reconciliation of data, including SAS/AE and third-party data, against the clinical database.
• Provide status updates and highlight any issues/risks to deliverables to ensure team and Sponsors are informed.
• Present at investigator meetings and PM/CRA training sessions as needed.
• Identify and recommend process improvements to management.
• Coordinate and collaborate with internal and external stakeholders.
• Monitor study budget and identify out-of-scope tasks.
• Execute quality tasks with minimal supervision.

Requirements

• Minimum Educational Requirement: Preferably Life Science graduate or equivalent qualification.
• 5+ years of experience in clinical data management within CRO, Pharmaceutical, or Biotech industries.
• Proven knowledge of clinical data management processes and clinical database systems, including Electronic Data Capture applications.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite including Word and Excel.
• Strong problem-solving, analytical, organizational, and time management skills.
• Flexibility and ability to thrive in a fast-paced growing organization.
• Ability to work effectively in a global team environment.
• Basic understanding of Clinical Trials and data flow.
• Compliance with ICH-GCP/regional regulatory guidelines and POI SOPs.
• Understanding of study documentation standards including Trial Master File organization and archival processes.
• Familiarity with data standards, preferably CDISC STDM.

This is an office-based role located in Chennai/Bangalore, India. Please apply on the Lifelancer platform at the link below for screening steps and quicker responses.

Company Name: Lifelancer

Job Title: Clinical Data Manager - Hybrid