Clinical Data Manager

Profile : Clinical Data Manager

Location : Chennai onsite

Experience : 4 to 12 years in Clinical Data Management

Remuneration : Best in industry

Immediate joiners preferred. Max 45 days notice.

Job Description : Clinical Data Manager

ROLE RESPONSIBILITIES :

- Participate in DMM activities including data review and query management, assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems, supporting the database set up activities as assigned by Senior Data Manager or Clinical Data Scientist.

- Ensure work carried out in accordance with applicable SOPs and working practices.

- Assist with the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.

- Assist with operational excellence in collaboration with other Data Manager's and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities

QUALIFICATIONS :

- Awareness of clinical development and pharmaceuticals as a regulated industry

- Awareness of healthcare regulatory authorities (e.g. FDA, Health Canada)

- Ability to learn clinical data management processes and principles in area of responsibility.

- Demonstrates required verbal and written communication skills including ability to communicate remotely.

- Capable to learn technical data systems.

- Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review).

- Awareness of MedDRA/WHO-Drug preferred

- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

- Bachelor's degree minimum requirement. Health Sciences experience or Technology degree preferred.

- At least 7 years of experience in Clinical Data Management, performing complete data review activities, in a CRO or a Pharma Company.

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