Job Opportunity at Sobi in Sweden: ISS Coordinator

Date limite : 01 févr. 2020

Organisation à but non lucratif: SOBI

Spécialités: Médecine et Santé

Niveau d'études: Etudiant

Consultée 232 fois

Job Opportunity at Sobi in Sweden: ISS Coordinator

Sobi is offering a job opportunity in its headquarters in Sweden, as it is looking for an ISS (Investigator Sponsored Studies) coordinator to join the Medical and Scientific Affairs Team. ISS Coordinator role is to coordinate aspects of ISSs for one or more Sobi products/projects globally and manage the Sobi operational responsibilities follow-up in collaboration with the Sobi Study Liaison.

Required Qualifications:

  1. Life science degree with a minimum of 5 years’ experience within clinical drug development.
  2. Excellent written and oral communication skills in English.
  3. Excellent project management skills including negotiation and conflict resolution skills.
  4. Demonstrated skills coordinating multi-disciplinary teams and optimizing the contribution of team members.
  5. Collaborative, Accountable, Respectful and Engaged (Sobi CARE values).
  6. Strong interpersonal skills with a communicative and flexible attitude.
  7. Ability to work independently with a proactive approach to study coordination.
  8. Excellent problem-solving skills.
  9. Organization skill and multi-tasking abilities.
  10. Strong customer-oriented mindset.

Desired Qualifications:

  1. Experience from planning, conducting and reporting international clinical studies.
  2. Extensive knowledge of all aspects of the clinical study process.

Job Responsibilities:

  1. Arrange timely product/project-specific ISS EC meetings with relevant members.
  2. Maintain a complete and updated ISS database with full tracking of each ISS proposal/study including documentation and decisions made.
  3. Summarise and distribute ISS proposals to ISS EC members in a timely manner before ISS EC meetings.
  4. Ensure that any existing contractual agreements between Sobi and external parties concerning restrictions of product development are considered and evaluated.
  5. Support ISS EC in ensuring that any study support is compliant with local regulations and Sobi and industry policies.
  6. Convey the decisions of ISS EC to Study Liaisons.
  7. Facilitate development and negotiations of contracts between the Sponsor and Sobi in collaboration with the Study Liaison, product/project team and headquarter supporting functions as required.
  8. Ensure that a proper Supply Chain is set-up and maintained together with the Study Liaison and Sobi Supply Chain.
  9. Ensure the tracking of distributed investigational products.
  10. Ensure all required documentation and processes are finalized and give the final sign-off on behalf of the ISS EC to initiate support.
  11. Provide regular status updates of product/project-specific ISSs to the responsible Global Medical Director and the ISS EC.
  12. Escalate any identified issues related to ISSs to the responsible Medical Director or ISS lead as appropriate.
  13. Follow up ISS central budget, track milestone payments and to report ISS budget to the responsible budget owner.
  14. Ensure manuscripts from studies are reviewed according to agreed timelines in collaboration with Scientific and Medical Affairs.
  15. Update and archive ISS Study Documentation, including study proposal, study protocols, agreements, and other mandatory and supporting documentation.

About Sobi:

Sobi is transforming the lives of people affected by rare diseases. As a specialized international biopharmaceutical company, it provides sustainable access to innovative therapies in the areas of haematology, immunology and specialty care. Approximately 1050 employees around the globe have been instrumental in Sobi’s success across Europe, North America, the Middle East, Russia, and North Africa.

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Pays hôte: Suède


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