JOB OVERVIEW:

The Clinical Data Manager assists and supports the planning, execution and delivery of Clinical Data Management projects on schedule and within budget in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Positive Clinical Practice (GCP), ICH Guidelines and sponsor requirements.

EXPERIENCE - 1 to 8 Yrs

JOB RESPONSIBILITIES

- Develop and implement project timelines.
- Plan and execute multiple data management projects simultaneously.
- Provide input, assistance and/or oversight with preparation of edit check specifications, case report form (CRF) design and specifications.
- Assist and/or oversee the creation of test data for entry screens and edit checks.
- Assist and/or oversee user acceptance testing (UAT) for assigned projects.
- Create and maintain the project specific Data Management Plan (DMP) and other relevant study documentation.
- Assist and/or provide study status tracking and metrics.
- Review of data listings and reconciliation
- Discrepancy and query management
- Ongoing maintenance of electronic trial master file (eTMF)
- Perform study finalization activities.




- Ensure team member performance supports project budget and delivery requirements.
- Participate in and attend study team meetings, as required.
- Participate in department meetings and initiatives.
- Participate in and/or contribute to sponsor and/or regulatory audits and inspections.
- Perform other duties as required by the department.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

- University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- 2+ years data management experience working in pharmaceutical, biotechnology or Contract Research Organization (CRO) preferred.
- Additional relevant work experience will be considered in lieu of formal qualifications.
- Broad knowledge of drug development processes
- Understanding of global clinical development budgets and relationship to productivity targets

📌 Clinical Data Manager (Bengaluru)
🏢 Atorus Research
📍 Bengaluru