Clinical Data Manager I - II
Company - Quanticate
Bengaluru, Karnataka, India (On-site)
Full-time · Mid-Senior level
Pharmaceuticals
Job Description
- To lead, co-ordinate and action all tasks relating to Clinical Data Management from the start to the finish of a study.
- To project manage studies across DM functions.
Core Accountabilities:
- Activities required of a Clinical Data Manager I (however not restricted to) are as below:
Project management for allocated projects:
- To help plan and manage study timelines and resources.
- To manage progress against schedules and report to management.
- To perform project management across all functions for a study as appropriate.
- Management of CRFs and all related tasks.
- To contribute to the efficient running of the Clinical Data Management department as part of the Clinical Data Management leadership team.
- To pro-actively keep abreast of current data management developments and systems.
- To mentor data management staff.
- To assist in the creation and review of in-house SOPs.
- To research and provide input into in-house strategies and systems.
- To perform other reasonable tasks as requested by management.
Role-Specific Duties:
- Ensure launch, delivery, and completion of all Data Management procedures according to contractual agreement and relevant SOPs, guidelines and regulations.
- Ensure consistency of process and quality across projects.
- Be willing to travel both domestically and internationally as necessary.
- To undertake other ad hoc tasks as required.
Key Relationships:
- Act as the primary data management contact, both external and internal, for Quanticate projects.
- Manage work assignment and delivery of project tasks to the off-shore data processing and programming team as required.
Freedom to Act:
- Monitor and communicate project progress to the customer and project team, including use of project status reports, and tracking tools/metrics.
Education:
- Qualified to an appropriate standard, preferably to degree level in a life sciences subject.
Skills, Knowledge, and Experience:
- PC skills, including some knowledge of Excel and Word.
- Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform.
- Excellent organizational skills and analytical skills and attention to detail.
- Good communication skills (oral and written) and good analytical skills.
- Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
- Ability to manage competing priorities in a changeable environment.
- Ability to effectively lead project teams across multiple locations.
- Excellent project management skills.
- Ability to inspire effective teamwork and motivate staff.
- Ability to present at departmental and external client meetings.
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