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[High Salary] Clinical Data Manager

1 month ago

Bengaluru India Careernet Full time

Job Description

Key Skills: Data Management, Clinical Data Management, Database Design

Roles and Responsibilities:

- Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed
- Demonstrates a business understanding of the portfolio, products and indication to identify and assist in successful application of data management processes
- Provides feedback to assure well-written protocols. Recognize and resolve protocol issues that may impact database design, data validation, data integrity and/or analysis/reporting while making the best use of standards and best practices
- Leads the team through database build requirements, timelines and complete startup activities for study including: building the eCRF, completion guidelines, standard and simple rules, data validation plan and user acceptance testing (UAT)
- Set up and Manage external data in accordance with protocol requirements, process and validation requirements
- Performs DM maintenance and validation activities during the course of the study timely and with quality.
- Tracks and reports status and progress for assigned trials and projects. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
- Effectively communicates status updates and study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
- Responsible and accountable to ensure consistency of assigned trials with program level standards through technical implementation of Industry (CDISC and regulatory) Data Standards, providing support to business users and teams on their use and supporting the implementation of the Clinical Data Standards strategy.
- Mentors and assists Junior team members.
- Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence

Skills Required:

- Ability to work under pressure demonstrating agility through effective and innovative team leadership
- Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
- Excellent communication and problem solving skills
- Ideally 4 years&apos experience in Drug Development with at least 3 years&apos in Clinical Data Management
- Excellent verbal and written skills
- Ability to fluently read, write, understand, and communicate in English. Fluency in Chinese or Japanese of added benefit but not required.

Education: University or college degree in life science, computer science, pharmacy, nursing, computer programming or equivalent relevant degree. Masters Preferred. Languages: Fluent English (oral and written). Experience/Professional requirement