Job Description
Clinical Trial Data Administrator - 12 month Contact
The Clinical Trial Data Administrator leads Quality Medicine (QM) data, risk and project management activities.
In this context, the role will:
-Leads the preparation, execution and post-processing of medium complexity projects and contributes to strategic initiatives within global QM.
-Leads work-packages for the implementation of the end-to-end QM risk management process.
-Contributes to reporting for regional QM Heads as well as local, global Compliance Managers and Functional Leaders.
Accountabilities:
Acts as a Project Lead within QM.
. Leads medium complexity projects for enhancing the quality QM generated data.
. Leads process improvement medium complexity projects for continuous improvement of Medicine Quality Management System processes.
. Contributes to the development and implementation of innovative project management tools and facilitates utilization within QM.
. Leads assigned work-packages of the end-to-end Risk Management process together with Senior Data Analytics Operations Manager:
. Provides up-to-date data from multiple Medicine sources, to ensure identification of Process and Asset/Therapeutic Area risks by Medicine Business Partners.
. Track and report on risk status, including metrics and status of risk management plan activities.
. Perform plausibility checks of proposed risk plan activities to ensure global and local alignment.
Contributes to QM Reporting activities:
. Leads work-packages for the delivery of the global Quality Medicine Report (gQMR).
. Contributes to the development of the global and local Functional Quality Reports.
. Contributes to secondary qualitative data analytics to enable data driven decisions by Global and Local functional leaders.
. Act as a Subject Matter Expert for the Medical Quality Dashboard (MQD)system use.
. Educate and coach global and local Medicine colleagues in the interpretation of MQD data derived from multiple Medicine sources.
Requirements:
. Degree level BSc: 3 years’ GxP experience within the pharmaceutical industry, CROs, or regulatory authorities
. 3 year’s project management experience
. Experience with knowledge of clinical trials
. Demonstrated leadership skills and strategic problem-solving ability
. Strong computer skills, including MS Office, MS Project, database tools, and the ability to quickly learn new systems
. Strong analytical skills and critical thinking abilities
. Excellent organizational skills and ability to accomplish multiple tasks of varied complexity simultaneously
. Knowledge of processes in quality management
. Proactive ability to predict issues and problem-solving abilities
. Strong communication, interpersonal, and negotiation skills
. Excellent ability to present complicated content in a clear, comprehensible and target group-oriented manner, presentation confidence (in English)