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Clinical Trials Data Administrator

2 months ago

Bracknell UK, Berkshire, United Kingdom Boehringer Ingelheim Full time

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)