Telephone 0203 778 0909 | Email office@al2s3.com

Senior Project Data Manager – Stockholm, Sweden

  • Location:
  • Salary:
    negotiable / €50k - €60k
  • Job type:
    Permanent
  • Posted:
    2 weeks ago
  • Category:
    Data Management
  • Deadline:
    March 4, 2020
  • Languages:
    English

 

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.

 

Responsibilities

  • 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.

 

Education/Experience

Required: 

  • 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.

 

 

Apply

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:

 

 

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