Clinical Project Manager

At ethica CRO, we advocate for the well-being of research participants by conducting clinical trials that produce reliable data, allowing companies to bring safe and effective medical aesthetics and dermatology products to market.

We are currently looking for a highly skilled and motivated Clinical Project Manager (CPM) to join our dynamic and growing team. The Clinical Project Manager (CPM) is responsible for the planning, implementation, and overall execution of clinical projects. The CPM interacts with study Sponsors, study sites, CRAs, data management personnel, statisticians, IRB/REBs, and other individuals as appropriate and necessary to ensure that all study timelines are met.

Responsibilities

• Identify, track, and ensure timely delivery of key clinical study milestones;
• Acquire solid knowledge of study indications and therapeutic areas in order to fully understand protocol requirements, and to facilitate effective interaction with Investigators and site personnel;
• Assist the Director of Clinical Research and Associate Director of Medical Aesthetcs with preparing and executing sound project management strategies;
• Maintain the CTMS, provide updates to timeline and budget forecasts, track out-of-scope workflow;
• Proactively identify compliance risks and initiate preventive/corrective actions where appropriate;
• Ensure the timely flow of essential documents between ethica CRO, Sponsor, and investigative sites;
• Review and manage the distribution of site visit reports and confirmation/follow-up letters in accordance with the Monitoring Plan;
• Submit requests for study site/Investigator payments in accordance with the site CTA;
• Manage the review and approval of CRA travel requests;
• Manage and coordinate clinical study supply shipments;
• Manage vendors of clinical trial services;
• Coordinate the procurement of study supplies;
• Organize routine study management meetings and Sponsor teleconferences;
• Participate in study audits;
• Provide assistance to CRAs and other CPMs when required;
• Provide mentorship and training regarding project management processes to ethica CRO associates;
• Travel at approximately 0% - 10%;
• Perform other duties as assigned.

Qualifications

• 4+ years of clinical research experience
• CRA experience is a definite asset
• University degree in biological sciences or a health-related field
• Knowledge in Project Management/Site Management with proven strong project management skills.
• Strong scientific and clinical research knowledge with a strong understanding of clinical trial planning, management, and metrics.
• Ability to focus on multiple deliverables and protocols simultaneously.
• Ability to work efficiently in a remote and virtual environment.
• Ability to identify problems, conflicts, and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.
• Solid understanding and knowledge of ICH-GCP guidelines.
• Excellent interpersonal, time management, and communication skills in English and French.
• Strong computer skills.

Salary will be based on experience and ability. Only those candidates who sufficiently fulfill the job criteria will be contacted for an interview.