Clinical Project Manager - Eurocine Vaccines AB - Avslutad

Eurocine Vaccines is a publicly listed company, using its clinically validated technology Endocine™ to develop a patent protected nasal influenza vaccine for children. Within the market for influenza vaccines, children is the fastest growing segment. This is due to the recommendations by the WHO to vaccinate children against influenza. The company’s main project, the nasal quadrivalent influenza vaccine Immunose™ FLU, has entered clinical development during fall 2016. The company plans to license the product to partners for further development and commercialization.

The successful candidate will be part of the Eurocine Vaccines R&D team being responsible for ensuring overall coordination and management of clinical trials. He or she will interact directly with the clinical team including the clinical CRO, the medical monitor/advisor and other relevant clinical consultants to support the development of Immunose FLU. The role holder will provide support to the project for optimal development of the clinical strategy and plans for regulatory approval.

Key Profile Areas

  • Overall coordination and management of clinical trials from startup to closeout according to the protocol and study plan 
  • Preparation, oversight and review of all study related documents including contracts, protocols, vendor and site budgets, etc
  • Prepare and review the clinical study protocol including study design, the IB, clinical sections of IND/IMPD, informed consent forms, clinical study reports and risk-management plans with help by clinical CRO and project physician
  • Contribute to the preparation of essential clinical study documents (CRF, DMP, DDP, SAPs, charters)
  • Assist in the conduct of study site initiation visits (preparation, personnel training, etc.) and study start-up and close-out meetings 
  • Ensures that studies are conducted in accordance with the protocol, GCP /ICH guidelines, regulatory requirements and relevant SOPs
  • Serves as primary contact for CRO and vendor personnel, provides oversight and management of CROs, consultants and vendors
  • Organize and lead CRO/vendor meetings, maintain study timelines, and provide study updates to management team
  • Participate in meetings with health authorities for development purposes
  • Routinely interface with discovery, safety sciences, statistics, pharmacovigilance (e.g. SAEs and narratives), regulatory, development operations and other members of the extended project team to deliver studies according to the clinical development plan

Required education and qualifications

  • At least 5-7 years relevant work experience, preferably including drug development
  • GCP knowledge
  • Prior experience of managing phase I-II clinical studies
  • Experience with clinical program management up to phase III studies
  • Ability to appropriately challenge status quo and propose solutions
  • Experience in submissions and discussions with health authorities
  • Translation of strategy into operational objectives and goals
  • Expertise of vaccines or biologics is an advantage

Required Competences

  • Excellent written and verbal communication skills (in Swedish and English)
  • Strong understanding of clinical studies including GCP and ICH-GCP guidelines
  • Ability to collaborate effectively with all consultants/CROs involved in the clinical research and the internal project team
  • Leadership, capacity to coordinate several activities
  • Ability to communicate effectively on medical/scientific issues and build consensus
  • Delivering results with speed, quality and value

Eurocine Vaccines is co-operating with the recruitment agency Aktivia Science Work AB in this recruitment. Please call Knut Natt och Dag on +46 722 16 68 00 if you want more information or want to discuss this recruitment project. Send your application containing a personal letter and CV to knut.nattochdag@aktivia.se. Write "CPM Eurocine Vaccines" in the subject field. We are working continuously with this recruitment project and would like to receive your application as soon as possible. 

Aktivia Science Work AB is a recruitment agency within Life Science. We are members of SwedenBIO and Medicon Valley Alliance. You can read more about us on our website - www.aktivia.se

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