Director of Clinical Research Operations
7 days ago
Nova Scotia Health Authority is seeking a highly skilled and experienced professional to lead our Clinical Trials Unit. As the Director of Clinical Research Operations, you will be responsible for the operational support of clinical trials and non-interventional studies spanning over 30 therapeutic areas and active research projects.
Reporting to the Senior Director of Research, you will oversee the operational excellence of over 20 high-performance research teams and clinical research professionals within a matrixed reporting environment. You will be accountable for timelines and key performance indicators (quality and operational) using cutting-edge tracking systems and project timelines.
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. You will bring knowledge of GxP practices, Health Canada Division 5, and TCPS-2 while working closely with our quality and ethics teams.
Key Responsibilities:
- Lead the operational support of clinical trials and non-interventional studies
- Oversee the operational excellence of research teams and clinical research professionals
- Accountable for timelines and key performance indicators (quality and operational)
- Collaborate with quality and ethics teams to ensure compliance with GxP practices, Health Canada Division 5, and TCPS-2
- Develop and implement large-scale SOPs and policies
- Build external relationships with industry and government partners
Requirements:
- Master of Science or higher in a clinically relevant research discipline with strong research operations foundation required
- 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
We would love to hear from you if you have the following qualifications and experience.
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