Position : CLINICAL OPERATIONS MANAGER
Red Rock Regeneration Inc is a biotechnology and medical device company whose mission is to provide safe, effective and affordable products for bone regeneration.
We launched our Natural Matrix Protein™ (NMP) series of tissue-based products in January 2022 (see www.inducebiologics.com).
Job Description
Reporting to the Chief Scientific Officer (CSO), the Clinical Operations Manager will lead and manage the operational aspects of Red Rock’s growing portfolio of clinical research projects.
The Clinical Operations Manager will be involved in strategic planning, engagement of physician researchers, development of clinical trial protocols and oversight of the day-to-day aspects of sponsored clinical studies to ensure project objectives are met compliantly and efficiently.
Location : 65 International Blvd., Toronto, Ontario
Terms : Hybrid (in office at least 3 days per week)
Hours : 40 hours per week, Monday to Friday
Salary : $80,000 to 125,000 per year based on experience ad qualifications
Duties & Responsibilities
- Manage clinical evidence team day-to-day operations
- Contribute to clinical strategy planning
- Collaborate with internal and external stakeholders
- Planning and execution of Red Rock sponsored trials
- Ensure compliance to standards, regulations and procedures
- Direct and support ethics and regulatory submissions, as needed
- Manage ongoing safety assessment activities
- Manage publications and presentations
- Monitor the progress of research activities and prepare periodic reports for investigators, management and regulatory bodies
- Manage Key Opinion Leader (KOL) engagement, as applicable
- Manage vendors and service providers supporting aspects of clinical trials
Critical competencies required
Knowledge :
- Knowledge of good clinical practice (GCP) regulations (required)
- Knowledge of regulatory pathways and processes in North America (required)
- Knowledge of ethical standards (required)
- Knowledge of clinical databases (preferred)
- Knowledge of spine / orthopedic surgery (preferred)
Skills & Experience :
- Excellent oral and written communication skills
- Excellent interpersonal and organizational skills
- Excellent time management and project management skills
- Experience with ethics board submissions (required)
- Experience with clinical study operations (required)
- 3-5 years of clinical research experience; include study management experience (required)
- Team management experience (preferred)
Qualifications
Bachelor's degree in scientific or healthcare fields (required)
Master’s degree or higher (preferred)
Clinical Research accreditations (preferred)
Valid passport, must be able to travel to the US
To apply please send a resume with cover letter addressing how you meet the criteria to [email protected]
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