Senior Clinical Data Manager
A global biopharmaceutical company, focused on the development of prescription drugs that target unmet medical needs, is currently recruiting a Senior Clinical Data Manager. This is an exciting opportunity to bring expertise and skills to an established and in-demand company that is committed to improving patient outcomes and quality of life in oncology and bacterial infections.
- Defining and managing Clinical Data Management timelines on multiple studies or programs.
- Coordinating/performing CDM activities for assigned studies/programs, including eCRF design, EDC system set up, user acceptance testing, users training, database release, data review and query generation and data coding.
- Preparing data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs.
- Ensuring appropriate study specific training is provided to assigned study teams and documented.
- Ensuring ongoing and timely data capture and data cleaning, including external data sources.
- Providing/coordinating data management support to study teams to support timely and ongoing data review and monitoring.
- Ensuring study timelines are met and data quality is according to high industry standards
- Lock, transfer and archive databases.
- Ensuring adherence to GCP, regulatory guidelines, standard processes and SOPs.
Skills and Requirements:
- Scientific or technical education background, ideally university level.
- Experience of 5 years minimum in clinical data management, with strong experience using major EDC systems and related tools and technologies.
- Experience leading data management studies and teams to timely deliver quality databases that meet regulatory requirements.
- Good planning, organisational and communications skills.
- Ability to effectively work and collaborate in a complex matrix organisation.
- Fluent in English, good knowledge of French an asset.
- An international and highly dynamic environment.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.