Clinical Research Manager

COMPANY SUMMARY:

Initio Medical Group offers diagnostic services, therapeutics and clinical research. Initio Medical Group is committed to strengthening Canada's clinical research ecosystem by growing our Clinical Research Department to provide patients with evidence-based care and accelerate patient access to emerging therapies

Passion, compassion, and precision are core values that we strive to achieve in everything that we do.

POSITION SUMMARY:

We are seeking a highly organized, motivated, and adaptable individual to join, Initio Medical Group's Clinical Research Department as a Clinical Research Manager. The ideal candidate will thrive in a dynamic environment, have a passion for research and patient care, and possess excellent communication and multitasking skills.

WORK PERFORMED

Project Management

· Lead the planning, and execution of clinical research studies within the clinic

· Develop operational plans based on budget proposals, demonstrating strong judgment and critical thinking.

· Support Principal Investigator in assessing feasibility, resourcing, and timelines for new research projects.

· Lead study start-up activities, including site readiness, documentation, investigator coordination, and regulatory approvals.

· Identify project risks, operational challenges, and opportunities across the study lifecycle; propose mitigation strategies and escalate issues to PIs as appropriate.

· Serve as the primary point of contact between sponsors, CRAs, and patients.

· Chair and lead regular research, laboratory, and progress meetings.

Clinical Administration

· Support the day to day operational tasks of the clinic administration team

· Coordinate patient appointments and scans as per study protocols

Clinical Trial Operations & Regulatory Oversight

· Lead and coordinate ethics submissions, renewals, and amendments through central and local REBs.

· Ensure all studies are conducted in compliance with ICH-GCP, Tri-Council Policy Statement (TCPS), institutional policies, and study-specific SOPs.

· Develop, oversee, and supervise the development of study protocols, operational manuals, and Standard Operating Procedures (SOPs).

· Oversee recruitment, enrollment, and retention strategies; monitor performance metrics and troubleshoot recruitment challenges.

· Monitor study progress, data quality, and protocol adherence across all participating sites.

· Coordinate study start-up, conduct, and close-out activities at each site, including final reporting and regulatory documentation.

· Liaise with investigators, site coordinators, research assistants, ethics boards, sponsors, and institutional partners.

Data Management & Scientific Oversight

· Manage study data collection tools, databases and electronic case report forms.

· Monitor data completeness, consistency, and integrity across sites.

· Participate in data interpretation and contribute scientifically to study outputs.

Financial Management & Resource Planning

· Develop and manage detailed budgets.

· Oversee funding allocations and financial tracking

· Set up and manage contractor agreements and external service providers.

· Prepare scientific and financial reports for funding agencies and sponsors.

Team Leadership, Training & Capacity

· Supervise, train, and mentor clinical research coordinators, research assistants, trainees, fellows, volunteers, and students.

· Lead hiring processes, including job description development, candidate screening, interviews, and performance reviews.

· Provide ongoing training and support on study procedures, regulatory requirements, data entry, and data management.

Knowledge Translation & Dissemination

· Lead and coordinate knowledge translation (KT) activities, including content for websites, newsletters, and public-facing materials.

· Coordinate and contribute to abstracts, manuscripts, posters, and conference presentations.

· Prepare research findings for diverse audiences, including clinicians, funders, patient partners, and the public.

PREFERRED QUALIFICATIONS

· Experience in clinical research, as a research manager or the equivalent combination of education and experience preferred.

· Certification with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) is an asset. Completion of relevant clinical research courses or tutorials (i.e., TCPS 2, GCP, REB) is an asset.

Knowledge, Skills, & Abilities:

· Ability to communicate effectively verbally and in writing.

· Effective interpersonal and problem-solving skills, and the ability to participate in a collegial manner with the team.

· Ability to perform scientific writing and editing duties.

· Ability to develop and work with large clinical (e. g. registry data), research or administrative databases.

· Ability to effectively use MS Word, Excel, Outlook, Internet searches at an advanced level; experience with statistical software.

· Effective critical thinking skills and understanding of complex data management principles.

· Ability to maintain accuracy and attention to detail.

· Ability to work effectively independently and in a team environment.

· Ability to prioritize and work effectively under pressure to meet deadlines.

· Ability to manage multiple tasks and assignments.

· Ability to determine the nature and urgency of inquiries and issues, and triage appropriately.

· Ability to supervise/mentor staff

Job Types: Full-time, Permanent

Pay: $60,000.00-$75,000.00 per year

Benefits:

• Dental care
• Extended health care
• On-site parking
• Paid time off

Work Location: In person