Clinical Data Manager 2

Position Summary:

The Clinical Data Manager II is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements. The Clinical Data Manager II is able to assist and lead data management team and provide support to Lead Clinical Data Manager, develop project documentation, project plans, EDC system setup, data review and validation processes.

Role & responsibilities

Implements, monitors and supervises data management activities within assigned clinical trials, i.e., is responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans and Data Management Plans

Provides the study status updates with respect to data, using standard reports (CPT, data entry, queries, SDV, safety reconciliation etc.) and communicates efficiently the status to the team

Creates and executes data quality checks throughout the study conduct

Day to day responsibilities (under the guidance of senior personnel) may include but are not limited to:

• data review,
• open/close queries in the eCRF,
• medical coding,
• central lab data reconciliation,
• PK data reconciliation,
• ad-hoc data reports creation,
• User Acceptance Testing (UAT) of internal and external electronic Data Capture systems

Provides support to the resolution of issues and inputs ideas to help resolve issues and contribute to continuous improvement

Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection

Key competencies:

• Excellent knowledge of CDISC/SDTM/ADAM specifications Excellent IT skills and MS Office command
• Ability and willingness to operate independently
• Ability to communicate effectively both verbally and in writing
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Demonstrate quality driven mindset while performing any of the assigned tasks
• Excellent knowledge of ICH/GCP, 21 CFR Part 11, guidelines and regulations, particularly those relevant to clinical data management
• Ability to work according to specific SOPs, guidelines, regulations & ethical principles in

the daily practice

Professional Experience Requirements:

• Required: 8 Years experience as Clinical Data Manager Phase I -III Studies
• Desirable: Experience working with Medidata Rave

Education Requirements:

• Required: BSc in Statistics, Biostatistics, Mathematics, Data Science or other applied sciences relevant field, life science, pharmacy or related subject or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

• Desirable: MSc in one of the above fields