A client with very interesting and innovative products in the pipeline is looking for an experienced Data Manager to complete the DM team.
- Do you have more than 5 years of experience as Clinical Data Manager in a pharmaceutical and/or CRO setting?
- Have you been involved with CRF development?
- Are you passionate about Datamanagement and are you ready for a next step in your career?
You should definitely apply then! It would be our pleasure to provide you more information and we will always give you feedback after you send us your CV!
As senior Data Manager you set up, structure and perform all DM activities within the framework of clinical trial activities to ensure the completeness, accuracy and consistency of the data so that they meet the standards of quality for reporting to regulatory bodies in compliance with local and global regulations.
The Senior DM is involved in every clinical trial program in order to perform all necessary activities.
You have regular contact with other departments: Project Manager, Line Manager, Project Team Members, Medical Director, other Clinical Operations Department Members (medical writers, drug supply manager and CRA’s), Biostatistician, QA department, PK/PD team. You are also the contact person for international experts, CRO’s, external service providers (CRF printing, IVRS vendors, Central Labs), Regulatory officers.
- Manage DM activities and (jr.) CDM
- Planning and organization of DM tasks
- Timely delivery, prioritizing of DM tasks
- Manage, motivate and help developing the different department members
- Creation of COSOPs and other relevant DM (general) documentation
- Define and create all DM related COSOPs, Work Instructions, Guidelines, processes, documents and other tools to build an efficient Data Management team and ensure the smooth running of the Department’s activities.
- Protocol development
- Contribution to protocol design (e.g. what and when data are to be collected, feasibility of data collection)
- Protocol review
- CRF development
- CRF design (including responsibility review meetings)
- Creation of CG
- CRF printing and shipment to the sites
- CRF annotation (PheedIt and SDTM)
- Review of other data collection forms (e.g. source documentation, patient diaries,…)
- Build and maintain PheedIt database and other study set-up activities
- System owner tasks: Validate (PQ) PheedIt, Make sure PheedIt is running properly and up to data (organize installation of hot fixes etc)
- Set up database (create study, different modules, variables, code lists etc) and make it ready for production (UAT)
- Training investigators and clinical research associates to help improve the quality of the data being collected
- Data entry and data review (clinical trial conduct)
- Responsible for data entry activities (implies organisation of first and second data entry)
- Coding of medication and AEs according to MEDDRA, WHO coding conventions
- Definition and creation of data validation checks and listings
- Performing data base queries (DCF) to resolve deviations
- External data reconciliation (LAB, IVRS, PK)
- Protocol Deviations definition and review
- SAE reconciliation
- Development of Data-Management plan (trial specific documentation)
- Coding guidelines
- Review guidelines
- Data Entry guidelines
- Data validation checks and listings
- Identification of protocol deviations
- Description of full content of complete database (define.html)
- AE reconciliation
- Define Lab Transfer Specifications
- Participate in Regulatory Agency and internal audits when appropriate
- You have a master Degree in Biomedical Sciences, Bio-engineering, Pharmaceutical Sciences, Mathematics, Statistics, Chemistry, etc. or equivalent experience
- You have >5 years experience as Clinical Data Manager in a pharmaceutical and/or CRO setting and have adequate experience in CRF development.
- You are specialist in DM software (platform).
- You have knowledge of the working of an R&D, Clinical Development, QC (GCP), regulatory environment, etc.
- You are able to work independently but also in a team environment.
- You have convincing skills, reporting skills and analytical skills.
- You have high quality standards and an eye for details, you need to be very meticulous.
- You are fluent in English.
- You have problem solving & innovation skills: problems are situated on the level of misuse, misunderstanding of clinical data and its added value by colleagues.
- You have the capability to organize the work(load) (timely delivery of all tasks and ensure correct result) and to motivate the clinical trial project members.
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