PRIMARY PURPOSE

The Clinical Data Manager has responsibilities for providing technical support activities for clinical research studies. The Clinical Data Clinical Data Manager co ordinates with internal project staff and clinical sites on all aspects of study compliance and data collection.

PRIMARY RESPONSIBILITIES :

- Provides data management and operational support for a protocol or group of protocols.

- Possesses detailed knowledge of the protocol and its associated activities and timelines

- Collaborates with the project team and other study personnel to determine data collection requirements based on the study protocol.

- Designs and develops electronic case report forms (eCRFs) and is responsible for the testing and validation of study-specific electronic data capture (EDC) systems.

- Reviews, implements and evaluates validation processes (Integrity and/or other methods). Generates queries, produces and distributes anomaly reports and resolves data discrepancies.

- Prepares and reviews study and project materials, (e.g., Manual of Operating Procedures (MOPs), User's Guides, Data Management

- Handbooks, and Standard Operating Procedures (SOPs).

- Participate in site update calls and sponsor calls, as needed.

- Performs quality assurance activities for interim and study-close out database locks.

- Attends and participates in project and functional group meetings.

- Performs data entry as necessary.

- Support project statistician to review project-specific reports, as needed.

- Helps to create and maintain documentation on all data-related activities in alignment with project-specific and corporate SOPs.

- Ensure accurate, effective and timely communication of study status and discrepancies to senior members of the team

- Performs internal data audits and other project quality assurance activities and documents processes as required by corporate/project SOPs.

- Participate in corporate QA meetings with the Internal Quality Audit Team (IQAT), ensure adherence with project-specific SOPs and compliance/variance table, and participate in internal/external audits, as required. Ensure adherence to GCP and ICH guidelines.

- Assists with the orientation of new personnel.

EXPERIENCES AND COMPETENCIES

- Strong data management and computer skills

- Self-motivated and detail oriented

- Excellent oral, written and interpersonal communication skills

- Skills in prioritization, time management and planning

- Good understanding of GCP principles and other regulatory standards in Clinical Research.

- Ability to work independently, as well as in a complex team environment

EXPERIENCE : 3 -4 years of related experience

EDUCATION : Master's degree in health-related field

DEPARTMENT: Clinical Data Management (India)

REPORTS TO : Senior Manager/Manager (India)

Candidates from Bangalore will be preferred.

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