Clinical Data Manager-1 (Rave EDC development)

Position Summary:

The Clinical Data Manager I 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 I is responsible to ensure that the data management activities on a given trial are being performed as per the plan. The Clinical data manager I is able to independently create various documents like CRF entry guidelines, Data Management Plan etc.
as listed in the roles and responsibilities.

Main Duties & 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:
o data review,
o open/close queries in the eCRF,
o medical coding,
o central lab data reconciliation,
o PK data reconciliation,
o ad-hoc data reports creation,
o 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.

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

Professional Experience Requirements:

- Required: 2 years work experience as Clinical Data Manager in Phase I-III Studies
- Desirable: Experience working with Medidata Rave

Language Skills Required:

- Excellent command of spoken and written English

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 details.
- Demonstrate quality driven mindset while performing any of the assigned tasks.
- Excellent knowledge of ICH/GCP, 21CFR 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.