Quanticate

Clinical Data Manager II

Job Locations IN-Bangalore
Posted Date 2 months ago(9/26/2022 3:20 AM)
ID
2022-1874
# of Openings
1
Category
Data Management

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.

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