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Clinical Operation Manager

 
Requisition ID:  1221
Location: 

Montreal, Quebec, CA

Date: 
 

We are looking for a qualified Clinical Operation Manager, to join the Lundbeck Canada Medical Affairs team. This position is permanent full-time and is located at our head office in Ville Saint-Laurent. The candidate will report to the Director, Medical Affairs.

Your Position

The Clinical Operation Manager is responsible to manage phase IV research activities in accordance with Lundbeck SOPs, GCP’s and other pertinent international and local regulations. He/she is responsible for all aspects of the clinical trial start-up including, identification, evaluation and management of CROs and vendors and closing-up activities. The Clinical operation Manager will also be responsible to manage the approved study budgets within specified timelines. This position reports to the Director, Medical Affairs.

 

External and internal relationship management (40%)

  • Responsible for managing the relationship with selected CRO and be the designated Lundbeck point of contact
  • Lead regular meetings with the CRO study team and provide study updates to the Director, Medical Affairs and Scientific Advisors
  • Liaise with Scientific Advisors and MSLs for providing input on sites selection, Investigator Meeting – content development and sites communication
  • Participate regularly in medical strategic meetings
  • Proactively in managing any study operational or CROs issues

 

Studies planning and execution (60%)

  • Ensure execution of local phase IV studies in accordance with Lundbeck global and local SOPs, GCPs and other relevant international and local regulations
  • Responsible for all aspects of the clinical trial start-up including, identification, evaluation of CROs and vendors
  • Facilitate contractual and budget negotiations with CROs and vendors and provide oversight and management of the selected CROs
  • Provide input on study documents like study protocol, CRFs, Informed Consent, clinical study monitoring plan, clinical study report
  • Provide insights on site selection, qualification, monitoring and ongoing site/investigator support and communication
  • Supervise the organization of the Investigator Meetings
  • Manage the approved studies budget according to the specified timelines

 

Position Qualifications:

  • Registered Nurse (R.N.) or University degree in Life Sciences or equivalent
  • 3-5 year experience in a pharmaceutical and/or clinical research organization, ideally in a similar position
  • Experience in executing phase IV, RWE studies – an asset
  • Good working knowledge of ICH, TPD Division 5 regulations, PIPEDA regulations
  • Proven track record in clinical project management and vendor management skills
  • Team oriented with excellent cross-functional team knowledge and active participation
  • Fluently bilingual in French and English
  • Proficient in the Microsoft Suite

 

Working conditions

  • Normal Office conditions: Yes
  • Evening/Weekend commitments: Occasional
  • % of travel required: 15%

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. 

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.