Clinical Project Associate

Feldan Therapeutics, a pharmaceutical company specializing in the development of intracellular delivery-based therapeutics, is seeking a Clinical Project Associate to join its dynamic team. The Clinical Project Associate (CPA) will be part of the clinical operations team and will be responsible for various activities and deliverables to ensure the successful execution of clinical studies. The CPA will report to the VP of Clinical Development and will support and/or coordinates various aspects of clinical studies, while operating within and maintaining the standards of Good Clinical Practice (GCP) as defined by ICH E6.

Key Responsibilities

Assist in the drafting and review of clinical study protocols;
Provide support in the design, planning and management clinical studies;
Contribute to the development of study-related documents and ensure compliance with regulatory requirements;
Support the clinical operations team with the engagement, contracting and management of required vendors and external partners for the assigned studies;
Support accurate budget, timeline & critical path management;
Develop and maintain study tools including trackers, spreadsheets, and filing systems for various studies;
Maintain accurate and up-to-date documentation for clinical studies;
Assist in the preparation and submission of regulatory documents;
Arranges meeting logistics, drafts meeting agendas and assists in preparing meeting minutes;
Conduct literature reviews and stay updated on relevant advancements in the field;
Support with clinical project audit and inspection readiness throughout the study lifecycle;
Support risk management of clinical operations;
Performs other tasks as assigned by line manager, that support the company's objectives;
Strict observance of Good Documentation Practices and Standard Operating Procedures (SOPs) in force within the company & applicable to the position.

Miminum Requirements

Must be familiar with standard clinical operating procedures;
Knowledge of ICH Guidelines & GCPs;
Must be able to work both independently and as part of a team;
Excellent verbal and written communication skills and interpersonal skills;
Strong working knowledge of Microsoft Project, Excel and PowerPoint;
Bilingual resource candidate required (French and English); French is the usual language used to communicate with employees and manage internal operations. English is essential for interactions with partners and investors in different countries;
Bachelor of Sciences /Bachelor of Business Administration in a scientific-related field.

Desired Skills

Excellent organizational skills;
Excellent oral and written communication skills;
Ability to manage a range of activities concurrently;
Strong interpersonal and collaboration skills; team player;
Open-mindedness and resilience in the face of change;
Analytical, critical and problem-solving skills;
Sense of responsibility, proactivity, versatility and adaptability.

Offered Benefits

40-hour workweek, day shift
Flexible schedule between 6:00 AM and 6:00 PM
Optional remote work two days a week
Group insurance (Health, dental, medication)
Employee assistance program
Telemedicine
Group RRSP
Vacation and wellness days
Work-life balance
Positive work culture focused on collaboration, fun, innovation, and excellence
Social activities
Bright and spacious work environment
Daycare (CPE) service reserved for employees of the nearby technology park
On-site parking

Those interested are invited to submit their application to Catherine Lippé (clippe@feldan.com).