Director of Clinical Research Operations - Research, Innovation & Discovery

About the Opportunity

This is a unique opportunity to lead a globally recognized clinical trials unit that is in the business of improving access to care through innovative research.

Reporting to the Senior Director of Research, the Director is responsible for the operational support of clinical trials and non-interventional studies spanning over 30 therapeutic areas and active research projects.

The Director will be responsible for the operational excellence of over 20 high-performance research teams and clinical research professionals within a matrixed reporting environment.

The Director oversees study level performance at a system level and accountable for timelines and key performance indicators (quality and operational) using cutting-edge tracking systems and project timelines.

This position oversees all operational and strategic aspects of research data management, while ensuring high levels of data quality to support evidence-based health care.

The successful candidate understands the importance of agile communication and can navigate any risks to timelines and / or quality, along with proposed solutions and mitigations.

Working to identify innovative approaches to decrease study start up times, this position will enhance shared service resources (pharmacy, diagnostic imaging, lab services, etc.

mitigate risks to active studies, and build capacity for future phase I-IV and investigator-led studies. They will be tasked with implementing best practices for the cost-effective management of core infrastructure within a health system context and collaborate with HR, finance, contracts, and procurement professionals.

The successful candidate will lead request for proposals and liaise with vendors as we expand our Clinical Trials Unit. Importantly, the Director will be responsive to the needs of our patients, families, clinical champions, and team members to simplify processes and enhance navigational supports.

With recent developments of our de-centralized clinical trial platforms and software solutions that match patients to candidate trials, the Director is a future-oriented thinker who embraces a test & try mindset to adopt cutting-edge approaches to the delivery of research studies.

This position requires a combination of an in-depth understanding of clinical research processes and operations alongside business acumen that tailors to the needs of our diverse partners.

They will bring knowledge of GxP practices, Health Canada Division 5, and TCPS-2 while working closely with our quality and ethics teams.

The Director must be able to build external relationships with industry and government in partnership with our business development team to ensure smooth delivery of studies.

This means thinking differently to facilitate first-in-class studies and accelerate studies that move at the pace of our partners.

The role requires the ability to build meaningful partnerships between research groups and clinical service units.

About You

We would love to hear from you if you have the following :

Master of Science or higher in a clinically relevant research discipline with strong research operations foundation required.

Licensed health professionals with equivalent work experience will be considered. (RNs, Pharmacists, Respiratory Therapists)

• Five years’ experience in research administration involving delivery of clinical trials and research involving human participants
• Five years’ experience in management and supervision of personnel with understanding of matrixed reporting environments
• Expertise in clinical trials, observational studies, and clinical research within a health system
• Proven strategic planning experience in research enterprises, especially public institutions
• Skilled in business intelligence and data science for operational gap analysis
• Exceptional interpersonal skills for diverse stakeholder interaction
• Comfortable in a fast-paced environment with occasional after-hours calls
• Experience with diverse staff and stakeholders; proven cultural competence
• Project management and change management experience; PMP and ProSci certifications are a plus
• Proven in partnership-building and executing major, multi-stakeholder initiatives
• Effective in managing multi-stakeholder projects
• Familiar with local health sciences research and inter-institutional process harmonization
• Business planning and budget management experience
• Ability to develop and implement large-scale SOPs and policies
• Knowledge of healthcare organizations and the health sector
• Excellent analytical, organizational, negotiation, and decision-making skills
• Ability to analyze and interpret statistical data and monitor performance indicators
• Up-to-date on data management best practices and analytic techniques

Please ensure your resume is up to date and includes all relevant education, experience, training, and certifications.

Hours

Permanent, full-time position;75 hours biweekly

Compensation

BANDR16 : $56.95 - $71.19 hourly ($, - $, annual)