Biometrics Project Manager in Belgium
il y a 1 semaine
CROMSOURCE is a full service CRO managing global clinical trials. We are recruiting for a Biometric Project Manager. This is an ideal opportunity to take the next step in your clinical data management career. This is a remote full time permanent role. Requirement
- 5 years of data management experience. Come join our internal team
**Main Job Tasks and Responsibilities**:
The Biometrics Project Manager will oversee the management of the Biometrics Division project related activities to ensure timely delivery of protocol, randomization, CRF, clean database, statistical output, meeting the required quality level, within agreed timelines and budgets.
- Act as Biometrics Project Manager, while having a sound Data Management background
- Perform Project Manager duties for all Biometrics Division activities, including project set-up, initiating and chairing project team meetings, project planning & coordination, project review and reporting, while ensuring appropriate quality of deliverables within agreed timelines and with control over the available budget
- Perform project related communication with internal and external clients to guarantee sufficient exchange of relevant information and to maintain good client relationship
- Keep insight and control over the hours spent per project and enable invoice generation
- Perform approval of invoices and expenses for the assigned study personnel
- Liaise with project managers, monitors, data managers, medical writers, statisticians and computer specialists to ensure optimal project conduct
- Provide support to the Clinical Project Development department in acquiring new business on request
- Facilitate the standardization of tools and processes in the department
- Assist the Data Management department director in overall capacity planning in order to support an optimal project staffing
- Support the Data Management Department Director by performing delegated line management tasks for Data Managers.. This may include training and coaching of junior staff, defining the yearly personal objectives, defining/implementation/follow-up of training plans, executing mid-year evaluations and annual appraisal meetings, and making suggestions for promotion
**Education, Experience and Skills**:
- Higher education in sciences, medical or paramedical sciences, medical information specialist or other equivalent scientific training
- Excellent knowledge of Data Management workflow and the relevant guidelines for the conduction of clinical trials (e.g. ICH-GCP)
- Good understanding of the statistics workflow in clinical trial
- At least five (5) years of practical experience in managing all Data Management activities within the conduct of all stages of a clinical trial or clinical investigation
- Excellent knowledge of EDC tools in the setup, conduct and closure of clinical studies and clinical investigations
- Fluent in English and local language(s)
**By joining our Biometrics Department at CROMSOURCE, you will**:
- Make a difference and influence change in the growing department, including working on initiatives to improve department efficiencies
- Have new opportunities for career progression/development, enabling you to progress within the department
- Be assured of a great work-life-balance through realistic and detailed planning and resourcing of project and non-project work
- Have the opportunity to be client-facing and working on studies from the start - regularly providing statistical input into study design and protocols
- Have the advantage of gaining varied knowledge through working in a wider setting within a mid-sized CRO on full-service studies (close working relationships with other key functions)
- Regularly work on a mixture of therapeutic studies in phases I-IV including drug, biologic and medical device
- Variety within your work - our clients are small and mid-sized pharmaceutical, biotechnology and medical device companies; you can become truly embedded within the pharmaceutical aspect, including having direct contact with bodies such as the FDA and EMA
- The chance to work not only on clinical, IMP studies, but also medical device projects too
**The Application Process
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
**Our Company Ethos**
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence
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