Location: Aachen, Germany
Schedule: Full-time, permanent
Are you keen to help make a difference and influence change in our growing department, where your opinions and ideas will be valued and where you can play a pivotal role in a growing department and company that continually develops? Then joining CROMSOURCE would definitely be a great step in your career.
CROMSOURCE Aachen has some great vacancies and are offering an enticing salary and benefits package.
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 timeliness 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 promotions
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 trials
- Good knowledge of clinical trials
- 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
Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.
Who will you be working for?
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 and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Key words: Biometrics Project Manager, Project Manager, Biometrics