Senior Project Data Manager – Stockholm, Sweden
AL Solutions are searching for a Senior Project Data Manager to work for a top Scandinavian Pharmaceutical company based in Stockholm, Sweden.
As a Senior Project Data Manager, you are responsible for Data Management tasks across a variety of areas from database setup through to database lock. You will also be responsible for various project management tasks for example leading the DM activities, managing CROs/external vendors, and handling timelines/deliverables/budgets.
This is an opportunity to join a Scandinavian Region Pharmaceutical company that offer excellent support, development, training and top of the market salary packages and benefits.
- Ensure high quality data management support for projects through the evaluation of CRO suppliers and provide input into outsourcing strategy and processes.
- Ensure that the appointed CROs SOPs and data management processes are in agreement with requirements.
- Provide data management input to relevant strategic study documents (e.g. study protocol) and vendor contracts.
- Work as a member of the Clinical Team to establish, communicate and deliver on a clinical data handling strategy and plan.
- Create or ensure development of relevant Data Management documentation (i.e. Data Management Plan).
- Create or ensure development of data transfer agreements with external vendors.
- Ensure data delivered is in accordance with requirements and standards.
- Ensure that defined data deliverables for in-licensed projects are transferred in accordance with requirements and standards, and to evaluate completeness and quality of the delivered data.
- Coordinate data deliverables and adherence to relevant government guidelines in preparation for submission.
- Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices.
- Validate or review study data in CDISC format using available tools according to standards.
Support and drive project- and company standards:
- Coordinate, develop and maintain internal project data standard.
- Coordinate, develop, maintain and implement internal process to adapt to CDISC standard.
- With insight in CDISC data standards and in company- and project needs, in collaboration with CRO, review and define study data mappings.
Support and drive enablement and finalization of regulatory submissions:
- Review, update or prepare regulatory delivery documents (e.g. define.xml)
Support and drive projects related technical equipment:
- Create or ensure compilation of user requirements in cooperation with concerned parties (e.g. study team, IT, QA) for new technical equipment to be used.
- Ensure new data system(s) and new technical tools/equipment(s) to be used are in compliance by following the established guidelines of national and international regulatory authorities.
- University degree in Life/Health Science,/Computer Science or
- Long Experience within Life/Health Science/Computer Science or other relevant areas.
- At least 5 year experience of drug development including computer applications, database systems and clinical development/clinical data management.
- Experience of regulatory submission in CDISC format.
- Familiar with CDISC conventions, i.e. SDTM and ADaM models and controlled terminology, and experience implementing and using these models.
- Familiar with common external coding dictionaries (e.g. MedDRA, WHO DD).
- Excellent skills in writing Data Management specific documents (e.g.Reviewers Guide, User Requirement Specification and Data Management Plans).
- Excellent skills in written and oral communication.
- Demonstrated project leadership experience.
- Demonstrated ability to find innovative approaches.
- Strong individual initiative and organizational skill.
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.al2s3.com or reach out to us via: