Director Clinical Operations

Sweden (SE)
90,000 Swedish Krona per month
04 Jul 2019
03 Aug 2019
Full Time
Contract Type
Experience Level

AL Solutions are looking for a Director Clinical Operations based in Stockholm.

Key Activities

  • Set-up and implement Sponsor Oversight Plan and Sponsor Oversight File
  • Conduct regular Trial Team Meetings (TTM) with (main) Service Providers
  • Set-up and management of timelines (update, revision as when needed in alignment with overall trial and project timelines
  • Oversight on trial key deliverables/milestones
  • Development, submission and implementation of Clinical Trial Protocol/Amendments and associated documents in close alignment within the Company and all concerned Service Providers
  • Keep budget within Service Providers current, provide oversight/ updates to Head Clinical Operations/CFO and keep track on performance, percentage of completion, obtain regular financial update reports, check invoices and reject/ask for modification as and when applicable
  • Attend and contribute to Project Team Meetings
  • Provide study status updates within the Company, as agreed and as when needed to Project Director, Head of Clinical Operations Senior Management, and others
  • Regularly assess quality and timeliness of deliverables as outlined in Sponsor Oversight Plan, and initiate/implement and supervise of remediation/contingency plans if and when needed
  • Proactively drive and oversee trial conduct
  • Be key contact person and insure close interaction, virtual and face-to-face, with Service Providers
  • Ensure close interaction with cross-functional experts involved in the clinical study
  • Ensure proper filing (Trial Master File, TMF, at Service Providers) and archiving at the Company.
  • Actively oversee/steer/coordinate the creation and update of study related essential documents (Clinical Trial Protocol/ Amendments, Subject Information/Informed Consent, etc.) and functional plans (e.g. Project Plan, Monitoring Plan, Data Management/Data Verification Plan, Statistical Analysis Plan, Safety Management Plan, Sample Analysis Plan, Investigational Medical Product (IMP) Manual, Lab Manual, etc.)
  • Interact with our clients QM/Compliance and oversee/contribute to and follow-up on audit set-up and reports, Corrective and Prevention Action (CAPA) set-up and resolution



Other Activities

  • Initiate and actively contribute to process improvement and other quality management activities at the Company, such as, but not limited to, SOP development/revision
  • Serve as Subject Matter Expert in Service Provider selection, Request For Proposal (RFP) and contracting process
  • Support other trial/project teams, as and when needed.


  • Education: An advanced degree in Life Science (e.g. Medical, Pharmacy, Biology, or similar)
  • Experiences: Professional experience in clinical research in Pharmaceutical or Biotechnology or CRO with proven expertise in all aspects of clinical trial management

Essential Skills

  • Ability to work independently
  • Strong written and verbal communication skills in English. Strong written and verbal communication in Swedish is an advantage
  • Highly Self-driven, effective interpersonal skills
  • Excellent leadership skills with confidence to direct and motivate others and to present complex undertakings and context (e.g. at Investigator Meetings, with multiple interdisciplinary team-members in-house and at Service Providers)
  • Excellent organization and ability to focus on details, but not to lose the overall picture
  • Proficiency with current applicable laws and GxP regulations for conducting clinical trials
  • Demonstrated flair, enthusiasm and innovation when faced with challenges and ability to provide strategic, tactical and operational management skills in the planning and execution of clinical trials
  • Critical thinking to determine the cause and appropriate swift solution in the early identification of issues
  • Strong time management with ability to multitask in a rapidly moving and changing environment
  • Proficiency with MS Office and working in a PCP/Windows environment, experience using common IT applications (such as, but not limited to EDC, CTMS, eTMF systems)
  • Ability to travel (domestic and international), as needed

Reporting Relationship: The Director Clinical Operations reports to the Head of Clinical Operations and Compliance.