A rare opportunity to join our internal team as a Senior Clinical Data Manager, located in Aachen, Germany or Verona, Italy.
Scope of the role:
The Senior Clinical Data Manager controls, co-ordinates and performs data management tasks for assigned projects in order to deliver high quality data for statistical analysis.
Position Duties & Responsibilities:
- Performs data management project duties, such as project set-up, project planning, project review and reporting, project administration, project co-ordination and mentoring, to ensure appropriate quality of data management deliverables within agreed timelines
- Programs or supervises the programming of the clinical trial database in the EDC environment
- Creates or supervises the creation of the data validation plan and programs data validation checks in SAS and /or the EDC environment
- Is responsible for creation, maintenance and locking/unlocking of the clinical trial database ensuring high-quality data processing
- Fulfils delegated responsibility by the Biometrics Project Manager (BSPM) for all in-house data management processes, including in-house review, data coding, discrepancy management, data validation in clinical trials and clinical investigations
- Performs communication with (internal and external) clients to guarantee sufficient exchange of relevant information and to maintain good client relationship
- Liaises with the clinical project manager, medical writer, statistician, computer specialists and monitors to ensure optimal data processing
- Higher education in sciences, medical or paramedical degree, 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)
- Excellent knowledge of clinical trials and clinical investigations
- At least six (6) years of practical experience in data management within the conduction of all stages of a clinical trial.
- Excellent knowledge of EDC tools in the setup, conduct and closure of clinical studies and clinical investigations
- At least 4 years of relevant experience in clinical database design and edit check programming
- Good knowledge of SAS and/or PL/SQL
- Good knowledge of English and local language
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.
The Application Process
Once you have submitted your CV in English, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002583
or please contact Teresa.Mendez@cromsource.com for more information.
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.
Keywords: Senior Clinical Data Manager, Data Management, Database programmer, EDC, Programming, Validation checks, Clinical Trials, Validation data, Reconciliation Data
Clinical Data Manager, Senior Clinical Data Manager, Clinical Data Management