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Manager, Trial Support

THE POSITION 

Oversees and manages Clinical Trial Operations Specialists (global and local), and Clinical Trial Co-ordinators 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. 
Functions as a subject matter expert in regulatory trial start up, engaging trial teams and CRO partners to deliver trials with execution excellence.

 

Responsibilities 

  • Oversight of the Clinical Trial Operations Specialists (global and local) who provide integral expertise in the conduct of local and 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. CTOS independently manage complex technical Clinical Trial systems to enable accurate reporting. 

  • Oversees and directs activities of the Clinical Trial Co-ordinators (CTC) who support Canadian trials and ensure accurate archiving and management of paper and electronic trial documents (including management of offsite storage and retrieval, share room and common drive maintenance). CTCs act in the capacity of archivist and custodian for CD&O Canada. Oversees CTC contributions to inspection preparation and conduct with respect to document retrieval, ensuring the quality and comprehensiveness of the site and country level Trial Master File (TMF)according to ICH-GCP, GDP, SOPs, WIs and local procedures. 

  • Collaborates on the Clinical Operations Management Team in order to strategically develop and implement innovative plans, programs and procedures that promote trial execution excellence and meet medicine excellence goals. This includes monitoring of key performance indicators.

  • Contributes to local as well as global TMF projects, TMF Governance Committee and provides input and recommendations with respect to revisions/updates of global SOPs/policies. Works to develop strategic plans and operational guidance for TMF management oversight. Provides input to Global Document Quality Centre teams as well as providing expertise both internally and externally with respect to TMF quality metrics.

  • As Manager of the Trial Support group, establishes a high-performance environment through cultivation of the BICL values, AAI, and CD&O Target behaviors which contribute to a culture of innovation, and an environment that encourages growth by embracing the diversity of people and their contributions.

  • Works with CRO partners and Regulatory Start Up teams to ensure optimized trial start up and conduct.

  • Collaborates with corporate CD&O functions to ensure optimal resourcing of global CTOS, providing recommendations, and input into resourcing plans as required/requested.

  • May contribute to local and international projects/trial assignments.

 

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

  • Problem Solving:

Entry level: Demonstrating 1 year: Mastering

When faced with complex problems, generates hypotheses, develops and actively executes solutions applying past learning as appropriate. Escalates issues and problems as appropriate.

  • Teamwork and Collaboration:

Entry level: Demonstrating 1 year: Mastering

Obtains and shares appropriate information, ideas and problems in a timely manner.  Maintains and fosters relationships and collaborates to prioritize organizational needs.

  • Project Management:

Entry level: Demonstrating 1 year: Mastering

Prioritizes plans and timelines based on potential risk identification and monitors a course of action; engages team members to enhance motivation, efficiency and productivity.

  • Communication:

Entry level: Demonstrating 1 year: Mastering

Fosters a healthy communication environment; expresses messages and data in an understandable, engaging and focused way; ability to effectively lead meetings, conferences and projects both in-person and virtually. 

  • Accountability:

Entry level: Demonstrating 1 year: Mastering

Clearly defines mutual expectations of self and others; takes appropriate actions to ensure obligations of self and direct reports are met in a timely manner; shows ownership for personal decisions and actions in all situations; takes accountability for mistakes and is open to sharing lessons learned; accepts accountability for deliverables.

  • Knowledge:

Technical/systems: Within six months demonstrates a working or functional proficiency level associated with technical/systems required to oversee/manage direct reports. Advanced proficiency with documentation management/archiving systems achieved within 6 months.

Clinical Research Environment: Demonstrates an indepth understanding of the requirements of the clinical research environment (Sponsor, Investigator and Regulatory).

SOP/guidelines: Within 6 months demonstrates a clear understanding and ability to reference as appropriate.

DEVELOPING: Minimal/Limited use, requires additional training to apply without assistance or frequent supervision (currently developing).

DEMONSTRATING: Demonstrates a working or functional proficiency level which enables the competency to be exercised effectively.

MASTERING: Demonstrates in depth proficiency level, able to assist consult or lead others in application of a competency.

  EXPERT: Demonstrates broad, in-depth proficiency; is recognized as an authority or master performer in exercising competency

 

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.  

Visit https://www.boehringer-ingelheim.com/ca/careers/benefits-rewards

 

READY TO APPLY?

Click the "Apply Now" button below to submit your application. We thank all applicants for their interest in our company.  Please note that only candidates selected for an interview will be contacted. 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 March 11, 2025. 

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