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Clinical Trials Data Administrator

2 months ago

Bracknell, United Kingdom Boehringer Ingelheim Full time

Clinical Trial Data Administrator - 12 month Contact



Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.

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)