Manager, Trial Support

2 weeks ago

Burlington, Ontario, Canada BI Canada Ltd Full time

The Position:

  • Manager Trial Support oversees and manages Clinical Trial Operations Specialists (global), and Clinical Trial Coordinators to ensure clinical trial start up, conduct and close out is optimized.
  • Optimization requires that Clinical trials: a) meet the strategic and regulatory requirements for registration of our products, and b) maximizes opportunities for patients to access our registered products. Scope includes strategic oversight of trial support to international and local clinical trials, document archiving functions, as well as quality assurance/control. Assumes a leadership role in strategic discussions and initiatives that ensure quality and completeness of the Clinical Trial Master file (TMF) as well as ensuring audit readiness of the TMF as this is a critical successful factor in the regulatory approvals of BI products.

Responsibilities:

  • Oversight of the Clinical Trial Operations Specialists who provide integral expertise in the conduct of global trials as assigned.
  • The CTOS is a key member of the Clinical Trial Team and is accountable for clinical trial execution excellence including planning, coordination and conduct of complex regulatory tasks, trial operations and communication to all applicable stakeholders.
  • Oversees and directs activities of the Clinical Trial Coordinators (CTC) who support Canadian trials and ensure accurate archiving and management of paper and electronic trial documents.
  • Collaborates on the Clinical Operations Management Team to strategically develop and implement innovative plans, programs and procedures that promote trial execution excellence and meet medicine excellence goals.
  • Establishes a highperformance environment through cultivation of the BICL values, AAI, and CD&O Target behaviours which contribute to a culture of innovation, and an environment that encourages growth by embracing the diversity of people and their contributions. Collaborates with corporate CD&O functions to ensure optimal resourcing of global CTOS, providing recommendations, and input into resourcing plans as required/requested.
This position is based in the Burlington, Ontario office located at 5180 South Service Road and is
flexible .


Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department.


Requirements:

  • Bachelor's degree in Life Science or business
  • 5 years clinical research experience
  • 5 years experience as a people leader within clinical research
  • Strong knowledge GCP, Health Canada regulations and corporate SOP's. Ensure all activities follow company procedures and processes.
  • Strong interpersonal skills required for communicating with customers This role manages varying levels of staff ranging from purely administrative to highly technical roles. This position provides significant contributions in establishing the development of new operational processes spanning across many of the functional teams within CD&O.

Total Rewards:


We offer a competitive salary, generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.


READY TO APPLY?:


Boehringer Ingelheim Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process.

If you require accommodation, we will work with you to meet your needs.

DEADLINE FOR APPLICATIONS:

Applications for this position will be accepted until May 11, pm MST)


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