Study Operations Manager I (cSOM1)

CTI Clinical Trial and Consulting Services; Calgary; On-site; CAD 70,000 - 110,000; Full time

Job summary

An established industry player seeks a Clinical Study Operations Manager to oversee clinical trials from startup to closeout. This role involves managing study activities, ensuring compliance with regulations, and leading a team to achieve operational excellence. You will be responsible for coordinating site recruitment, managing risks, and contributing to budget assessments. With a focus on nurturing talent and a commitment to diversity, this forward-thinking organization offers competitive salaries and comprehensive benefits. Join a team dedicated to making a difference in clinical research and advancing healthcare intelligence.

Benefits

Health Insurance

Retirement Plans

Well-being Programs

Various Leave Entitlements

Qualifications

• 5+ years of experience in operational clinical trials.
• Knowledgeable of Good Clinical Practice and regulatory environments.

Responsibilities

• Manage study activities from startup through to closeout.
• Lead the Local Study Team ensuring compliance and effective communication.

Skills

Operational Clinical Trials

Risk Management

Regulatory Compliance

Project Management

Education

Bachelor's Degree

Master's Degree

Tools

Site Technology Systems

Job description

Job Description: Clinical Study Operations Manager (C-SOM)

Join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence, as a C-SOM.

What you will be doing:

• Manage and oversee study activities from startup through conduct and closeout at regional and country levels.
• Manage study startup processes in assigned countries or oversee pCRO responsible for these activities.
• Support outreach, site identification, and feasibility processes to ensure country/site readiness.
• Provide input on startup and recruitment milestones during planning phases.
• Oversee pCRO and/or Country Trial Manager/Site Care Partners, maintaining accurate country plans.
• Identify and manage deviations and risks, implementing mitigation strategies.
• Lead the Local Study Team, ensuring compliance with regulations and effective communication.
• Coordinate submission strategies with Site Care Partners and Regulatory colleagues.
• Utilize local roles to gather intelligence and provide operational insights.
• Serve as the point of contact for study-level questions and issue resolution.
• Monitor issue status, identify trends, and improve processes.
• Ensure audit/inspection readiness and manage quality events.
• Coordinate site recruitment planning and data cleaning activities.
• Contribute to budget and cost assessments at the country level.
• Support the implementation of Pfizer's Site Technology systems.
• Assist with regulatory submissions and responses, ensuring timelines are met.
• Oversee PTMF setup and Investigator Site File management.
• Manage IP/equipment/inventory logistics and local vendor contracts.
• Support investigator meetings and the deployment of new trial technologies.

You are:

• Experienced in operational clinical trials.
• Possessing a scientific or technical degree preferred; BA/BS with 5+ years or MBA/MS with 3+ years of relevant experience.
• Knowledgeable of Good Clinical Practice and regulatory environments.
• Fluent in English.

What ICON can offer you:

We prioritize a diverse culture that rewards high performance and nurtures talent. Our benefits include competitive salaries, various leave entitlements, health insurance, retirement plans, and well-being programs. Visit our careers page for more information.

ICON is committed to an inclusive environment and equal opportunity employment. We encourage all qualified candidates to apply, regardless of background or identity.