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We are looking for individuals who are hardworking, passionate and focused on delivering strong data management support. You will have the chance to get involved in developing multiple activities and initiatives as well as shaping the culture and contributing to continuous improvement in solutions delivery.
Provide timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for assigned trials managed within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.
Provides Data Management leadership across one or several trials.
Reviews and contributes to preparation of protocols, specifically related to the Visit Evaluation Schedule (VES), Study Design and Data Management section
Develops and manages the Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials
Develops training materials and /or tools for conduct of the study
Disseminates study-level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
Responsible for leading study start-up activities such as preparing the electronic Case Report Forms (eCRFs), Case Report Form Completion Guidelines (CCGs), DHPs, DRPs and performing User Acceptance Testing (UAT) (if required)
Leads and participates in the ongoing review of all data generated from the clinical study including central and local lab data and coding Leads and participates in the review of listings for quality, content, format and output
Responsible for ensuring that clinical data is validated according to the DHP and DRP and are ready for interim and final deliverables by providing clean and consistent data
Identifies trends in the data and possible solutions for efficiencies
Supports and assists junior staff for assigned trials
Prepares final study documentation.
Leads in the final review of all data generated from the clinical study
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Fluent English (oral and written).
A minimum of 4 years’ experience in Drug Development with at least 3+years in Clinical Data Management
Market-leading salary will be offered depending on actual level of experience and skills
Permanent contract of employment with full DOCS benefits
Full comprehensive training program