Job Location: Bangalore
Overview: To manage allocated data management personnel (may include staff in remote offices).
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.
Responsibilities: Core Accountabilities:
Activities required of a Clinical Data Manager II (however not restricted to) are as below:
Management of allocated personnel:
o Allocation of projects in conjunction with Project Management, as appropriate.
o Performance reviews, as required.
o Administer training and development of personnel, as required.
Project management for allocated projects:
o To help plan and manage study timelines and resources.
o To manage progress against schedules and report to management.
o To perform project management across all functions for a study as appropriate.
o 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 produce a clear breakdown of bookable time for invoicing and ensure the same for direct reports.
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.
Freedom to Act:
Monitor and communicate project progress to the customer and project team, including use of project status reports, and tracking tools/metrics.
Key Relationships:
Manage work assignment and delivery of project tasks to the off-shore data processing and programming team as required.
Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals.
Qualifications: 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 leadership/management skills.
Excellent project management skills.
Ability to inspire effective teamwork and motivate staff.
Ability to present at departmental and external client meetings.
Job Type: Full-time
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