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.
Activities required of a Clinical Data Manager I (however not restricted to) are as below:
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 perform other reasonable tasks as requested by management.
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.
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.