Director Clinical Operations

Company
AL2S3 LTD
Location
Sweden (SE)
Salary
90,000 Swedish Krona per month
Posted
04 Jul 2019
Closes
03 Aug 2019
Ref
DIRECTCLINOPS
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

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.

Qualifications  

  • 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.