Description
Below are some key details for the role.Requirements:
- Scientific or Technical education background, ideally university level.
- Experience of 5 years minimum in CDM with strong experience using major EDC systems and related tools and technologies.
- Experience leading data management studies & terms to timely deliver quality databases that meet regulatory requirements.
- Good planning, organisational & communication skills.
- Ability to effectively work and collaborate in a complex matrix organisation.
Responsibilities:
- Define & manage CDM time-lines on multiple studies or programs.
- Coordinate/perform CDM activities for assigned studies/programs, including eCRF design, EDC system set up, user acceptance testing etc.
- Prepare data management plans, data validation plans & other study specific guidelines/procedures in compliance with standard processors & SOP's
- Ensure appropriate study specific training is provided to assigned study teams and documented.
- Ensure adherence to GCP, regulatory guidelines, standard processes and SOP's
Hopefully this role is of interest to you. If not feel free to pass it on to a friend or colleague who would be interested in the role.