Senior Clinical Data Manager
We are now looking for an experienced and customer focused professional to work in our growing team in a challenging global role based in Finland in Espoo as
SENIOR CLINICAL DATA MANAGER
YOUR TASKS AND RESPONSIBILITIES
- Operational responsibility as a study data manager, lead and represent CDM team as the Core Study Team member for internal and outsourced clinical studies, leading role in quality control activities, and coordinate the CDM Team in any aspect
- Member of cross-functional teams, close co-operation with Statistics following the principles of the Bayer-internal co-leadership model, serve as key contact on topics related to clinical data management activities in the Core Study Team
- • Lead the execution of data management activities in research and early development phases, preparation of submission data and required documentation
- Prepare, track and implement standard plans (i.e., DM study plan, data management plan, operational oversight plan, integrated data review plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities
- Provide oversight for outsourcing activities and input on budgetary items, risk and communication management and the application of data management best practices
- Ensure an adequate documentation of all data management activities according to existing SOPs and review study team documents for project consistency
- Support the implementation of biomarker strategies for studies and projects, organize the processes for pharmacokinetic data, define data flow strategies for support of advanced analytics activities
- Perform duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards
WHO YOU ARE
- University degree in natural sciences, life sciences, informatics or medical documentation
- Preferably at least 2 years experience of full responsibility as a Study Data Manager, or equivalent roles (e.g. professional study and/or project level expertise as a data manager) within a scientific, data-driven position in the medical research area.
- Significant experience in using data management and/or data sciences methodologies and technologies (e.g. electronic data capture (EDC), data warehousing, data analytics, programming skills [Python, R, SAS, Oracle])
- Understanding of the drug development process; demonstrated understanding of drug regulations and guidelines (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA])
- Strong organizational skills and ability to collaborate with minimal supervision
- Critical thinking and ability to support change in complex organizations
- The incumbent is required to conduct him/herself in an appropriate business manner adhering to a high ethical standard.
- Fluency in English, both written and spoken
We offer a competitive compensation, independent and challenging role in an international environment with a chance to develop your skills and experience further. To be considered for this exciting opportunity, please submit your application by Tuesday March 31, 2020 via www.bayer.fi under "Meille töihin > Avoimet Työpaikat". Candidates will be reviewed on a continuous basis.
If you feel this unique role is just what you are looking for, we are keen to hear from you! For further information, please contact Luiz Giorgiani, Head of Clinical Data Management RED II, Data Sciences & Analytics, Friday March 20 at 09.00–10.00 (EET) and Wednesday March 25 at 14.00–15.00 (EET), phone +358 400 449053.
Functional area: Clinical Development & Operations
Seniority level: Professional