Freelance Clinical Data Manager
- Experience Level
- Experienced (non-manager)
Senior/ Principal Clinical Data Managers
Remote across Europe
Jonathan Cunliffe at Umbilical Lifeis currently sourcing for an experienced Clinical Data Manager for a specialised CRO who will be responsible for leading multiple projects.
I would like to speak to talented individuals who wish to be part of an exciting & expanding team - focussed on quality across all programs. For a confidential conversation call Jonathan Cunliffe on +49 3221 421 9777 or email Jonathan@umbilical-life.com.
- Quality, planning, execution, monitoring, control and finalisation of all data management activities with effective management of timelines, budget and quality.
- Definition and maintenance of Data Management project plan, input into the overall project plan.
- Responsible for resource needs for the life time of the study including the identification and communication of short-term resource fluctuations. Flexible and efficient use of assigned resources.
- Implementation and maintenance of accurate, clear Data Management documentation. Responsible for the setup, maintenance and finalisation of the Data Management Study File
- Oversight of all data review activities; measuring progress against the project plan.
- Knowledge and understanding of contracted Data Management obligations and associated budget; Ongoing assessment of budget, regular and accurate review of Data Management progress against financial milestones and monthly completion metrics.
- Acts as the primary client contact for Data Management activities & leading all communication.
- Identifies, manages and communicates risk to timelines, quality and budget.
- Contributes to the ongoing development of the Data Management department through process analysis and improvement, mentoring, system enhancement.
- To effectively support regulatory and sponsor audits
- Degree in related Life Science Field.
- At least 5 years clinical data management experience in Pharma or CRO environment.
- Experience with regulations and standards; CDISC/CDASH.
- Experience with or dealing with Good Clinical Practice (GCP)
- Good level of English speaking & writing skills
- Ability to work independently and in groups and to perform indirect management tasks in an international context
- Proven initiative and problem-solving skills