Our client, a well-known Germany pharmaceutical company, is seeking a Global Study Manager (Oncology) to join their team in Norway. The company employs 12,000 people across six continents, including countries in Africa, South America and South East Asia.
- Single accountable for the execution and the delivery of global oncology studies to time, budget and quality as defined in the development plan and study protocol
- Ensure successful and high quality delivery of the oncology studies in accordance with ICH/GCP guidelines and regulatory requirements
- Single point of contact for operational planning and design, operational feasibility, and delivery of the study(ies) from commit to study synopsis until publication
- Lead the global cross functional study team to ensure study delivery and take operational decisions at study level
- Scope of work: leadership, study management, oversight, and project management of both global and in-country activities, as well as authorship of study documents
- Work closely with the Clinical Research Development Leaders, Epidemiologist, and Country Medical Directors
Education and Experience:
- University Degree in General Science or Life Science
- Preferred experience in healthcare / clinical operations / pharma industry (7-8 years industry background): ideally 2+ years of monitoring experience plus 3+ years general clinical operations background plus 2+ years global project management experience on clinical trials
- Profound experience with oncology trials (several years)
- Excellent understanding of the clinical study, drug development, sample management and quality requirements, including ICH/GCP guidelines and SOPs
- Excellent leadership skills, promoting motivation and empowerment in order to accomplish individual, team and organizational objectives
- Able to lead and work within teams and networks across functional and geographical boundaries, lead by example and promote collaboration
- Good project management skills (including scope, budget, timeline, resource planning and management, risk management and use of associated tools)
- Ability to deliver high quality results according to tight deadlines without losing sight of budgets
- Excellent English language skills (verbal and written)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Pontus Larsson on +44 203 3193 030 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.