Clinical development is a vital part of the company’s “value chain”. The CRM will not only oversee the clinical trial(s), but also act as a liaison between the trial site (study team), medical authorities and other relevant third parties such as Contract Research Organizations (CROs).
- Plan and oversee trials
- Determine whether a product accomplishes the goal for which it was produced
- Ensure products meets all government regulations and standards
- Manage external stakeholders, e.g. clinical research associates and medical specialists
- Attend relevant congresses and conferences
Clinical Research Manager reports to Medical Director.
DESIRED CANDIDATE PROFILE
A proper candidate possessing excellent communication and presentation skills, as well as the ability to organize and motivate others. He/she demonstrates enthusiasm, innovation, flexibility and leadership when faced with challenges. The candidate is solution-oriented and will provide strategic, tactical and operational skills in planning and execution of clinical research projects.
Previous experience in the management and coordination of clinical trials is desirable. Successful candidates have appropriate academic and/or vocational qualifications, typically holding a masters or doctorate degree in biology, life science, pharmacy or medicine.
DESIRED QUALIFICATIONS
At least 5 years in medical device and/or pharmaceutical industry.
- Experience with clinical trials
- Development of clinical investigation plans (protocol) and supporting regulatory documents necessary for approvals (e.g. IB, CTA, ICF)
- Exhibit proactive study team management skills (principle investigator, CRO, etc.) to meet study objectives
- Manage details of the study, such as budget(s) and maintenance of accounts
- Must possess strong knowledge of compliance areas such as laws and regulations for Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements
- Pharmacovigilance
- Fluent in Norwegian (or another Scandinavian language) and English
Collaborative and positive nature, focusing on team achievements.
OTHER
The position will be based preferably in the Company’s head office in Oslo (Skøyen), but Copenhagen is also an option. Periods with extensive travelling must be expected. The right candidate will be offered competitive salary and benefits and will join an exciting working environment with motivated team members.
For more information, please contact Geir Olderbakk, tel. no. +47 900 28 283 or Pål-Jørgen Nilsen, tel. no. +47 992 59 669 at Orion & Partners.
Would you like us to call you with more information? Text #702 to +47 900 28 283.