Contact us
English
Menu
Contact us
Feldan Therapeutics, a biotech company specializing in the development of intracellular delivery-based therapeutics, is seeking a Clinical Study Manager to join its dynamic team. The Clinical Study Manager (CSM) plays a crucial role in planning, executing, and monitoring clinical studies to ensure successful outcomes while operating within and maintaining the standards of Good Clinical Practice (GCP) as defined by ICH E6. Reporting directly to the VP of Clinical Development, the CSM is a key part of the clinical operations team and has a hands-on responsibility for the leadership and conduct of clinical studies, from protocol conception through the clinical study report, either through fully outsourced or hybrid operational model. The CSM also directly manages the CRO and interacts internally and externally with members of the cross-functional study team in the design, management, planning, and execution of clinical studies, including creating and managing timelines, budgets, and study management plans. 
 
Key Responsibilities

  • Accountable for operational aspects of assigned clinical study/ies and ensure key activities are well-coordinated;

  • Develop, maintain, and manage high-quality detailed study timelines;

  • Develop study budget and maintain monthly study budget forecasting and routine budget review;

  • Proactively manage the CRO in all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines;

  • Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate;

  • Oversee preparation of RFPs and prepare bid templates to facilitate selection of the CROs/vendors, and collaboration/supervision with team members performing these activities;

  • Collaborate with internal teams to negotiate and draft contracts and agreements with CROs/vendors and clinical study sites, as needed;

  • Contribute to the development of study-related documents and ensure compliance with regulatory requirements;

  • Ensure achievement of the clinical deliverables by regularly reviewing the study progress, providing status updates to the line manager and collaborating with cross-functional teams;

  • Plans and forecasts Investigational Product (IP) needs;

  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships;

  • Actively participate in the preparation of global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies);

  • Liaise with Regulatory Affairs to assure adherence to GCPs; and liaise with Feldan Quality Manager to ensure site and CRO/vendor audits are completed;

  • Contribute to clinical project audit and inspection readiness throughout the study lifecycle;

  • Perform study risk assessment and implement appropriate mitigations;

  • Perform 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.

Qualifications and Requirements

  • In-depth knowledge of Good Clinical Practice (GCP);

  • Must be familiar with standard clinical operating procedures;

  • At least 3 years of prior clinical operations experience preferably with CRO/small biotech experience;

  • Must be able to work both independently and as an integral team member;

  • Excellent verbal and written communication skills and interpersonal skills are required;

  • Strong working knowledge of Microsoft Project, Excel and PowerPoint, required;

  • Bilingual resource candidate required (French and English);

  • BSc/BA in a scientific-related field.

Desired Skills

  • Ability to influence, manage change and leadership;

  • Excellent organizational skills;

  • Excellent oral and written communication skills;

  • Creative thinking;

  • Ability to manage a range of activities concurrently;

  • Team player, strong sense of collaboration, ability to build relationships and interpersonal skills;

  • Open-mindedness and resilience in the face of change;

  • Analytical, critical and problem-solving skills;

  • Sense of responsibility, versatility and adaptability.

Offered Benefits
  • ​37.5-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
  • Fonds de solidarité FTQ RRSP
  • Eligibility for annual bonus
  • Vacation and wellness days
  • Work-life balance
  • Positive work culture focused on collaboration, fun, innovation, and excellence
  • Social activities
  • Bright and spacious work environment
  • Childcare (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).