Job Overview :
Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets.
Potential to assist in the development of the project Data Management Plan, including the creation of data acquisition conventions and data review guidelines / diagnostics specification;
and set-up of the data management systems according to project requirements.
Potential to serve as the technical data management leader on small projects with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets.
Education / Qualifications :
University / college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.
g., nursing certification, medical or laboratory technology).
In lieu of the above requirement, approximately 18 months experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one year’s clinical data management experience in addition to the two (2) years relevant work experience in data management will be considered.
Knowledge of drug development process.
Knowledge of effective clinical data management practices.
Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Fluent in English, both written and verbal.
Minimum two (2) years relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas.
Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
Potential ability to lead by example data management staff.
Demonstrated ability to work in a team environment and collaborate with peers.
Demonstrated interpersonal skills.
Excellent oral and written communication skills.
Ability to demonstrate a constructive problem solving attitude while dealing with time demands, incomplete information or unexpected events.
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