We are now looking for a professional with strong organizational skills and significant experience in using data management methodologies and technologies to work in an exciting and challenging global role based in a growing Data Sciences & Analytics team in Finland in Espoo as
SENIOR CLINICAL DATA MANAGER
YOUR TASKS AND RESPONSIBILITIES
- Ensure adequate application of Data Management Best Practices across studies within assigned projects.
- Support study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.
- Provide governance and oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor costing, synergies, change orders, etc.)
- Advise on resource planning/allocation based on forecasted clinical activities per the Clinical Development Plan (CDP) and actual study/project metrics.
- Organize state-of-the-art support for data-driven processes of interfacing business functions like Pharmacovigilance department, Pharmacokinetic department, Pharmacometrics department, and others by ensuring timely and high-quality Data Management input.
- Actively support assessment of future trends to prepare for the future, including personalized medicine, evidence-based re-imbursement, smart data storage, data insights, predictive and probabilistic data management methods, digital studies, wearable devices.
- Perform duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
- Contribute to cross functional projects and initiatives aimed at process improvement and optimization
- Serve as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases.
- Govern use of key data management elements across studies in assigned projects: assume ownership of development and maintenance of Medical Standards relevant to the area of responsibility; contribute to the definition of data structure standards; review applied results of the Important Medical Event (IME) List and, medical coding conventions.
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]) is an advantage
- 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 Thursday April 6, 2021. Candidates will be reviewed on 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 Thomas Auckinson, Head of CDM Development PAOW II, Research & Development via email: email@example.com for further questions.
Functional area: Data Sciences & Analytics
Seniority level: Professional
Location: Espoo, Finland