Clinical Trial Leader (CTL)

ROLE

Under the direction of the Director, Clinical and Scientific Affairs, the CTL is responsible for execution of clinical trials, from the site selection, start-up and enrollment phases up to the study closure, in compliance with the industry standards such as Scimega SOPs, ICH-GCP, FDA & Health Canada regulations, and in accordance with our client’s expectations.

The CTL is also responsible for customer relationships maintenance, and CRAs supervision.

ACTIVITIES / RESPONSIBILITIES

Site selection and Study start-ups

• Identify the clients’ expectations / objectives / deliverables
• Identify the performance metrics
• Identify the roles and responsibilities all parties involved from the sponsor, the external vendors and Scimega, as well as the communication process within parties.
• Set up Kick-off meetings with our clients
• Assist with the conduct of feasibility studies
• Recruit investigators in accordance with the feasibility studies
• Organize pre-study visits
• Organize and coordinate start-up activities at the different sites including negotiation of site’s clinical trial agreement and clinical grants
• Prepare / review training material for the study initiation visits
• Organize study initiation visits

Study management and maintenance of client relationships

• Develop and implement internal processes for the conduct of clinical trials, including, but not limited to, the monitoring plan, communication plan, tracking systems, study tools and safety plan
• Host / Attend conference calls and periodic meetings with clients and prepare minutes (as applicable)
• Manage Trial Master File (as applicable)
• Prepare and distribute progress reports to clients in respect with Scimega’s contractual obligations
• Prepare and distribute Scimega project review at every 2 months to Director Clinical and Scientific Affairs
• Interact / Collaborate with different vendors (as applicable)
• Write newsletters and have them approved by our clients (as applicable)
• Identify solutions to problems and take the necessary actions to avoid / minimize them and document the action in the Scimega project review
• Identify clients’ needs and change in the scope of work and communicate the information to the Director Clinical and Scientific Affairs and document in Scimega project review

Supervision of our CRAs

• Clearly communicate our client’s expectations, objectives and deliverables (performance measures) to the CRAs
• Plan and organize CRA training on the specifics of clinical trials and our clients’ needs. Ensure that all CRAs are adequately trained at all phases of the project.
• Ensure that all trainings are documented with a training log and are in the Scimega training binder.
• Provide initial study-specific training to new CRAs
• Schedule regular meetings and conference calls with the CRAs to discuss the progress of each trial and prepare the agenda and minutes.
• Discuss individually and regularly with each CRA to go over their performance measures
• Perform QC visit / Accompany CRAs during site visits on a regular basis
• Review monitoring reports and follow-up letters
• Support the CRAs (i.e. provide clarifications and answer questions, as applicable) and help them gain autonomy in their work and be proactive in their daily activities
• Review and approve CRAs timesheets

REQUIREMENTS

Tangibles (qualifications)

• Education : Bachelor’s Degree in a Health Science field or Registered nurse. A master degree would be an asset
• Experience : Minimum 3 years experience as a CRA or pertinent experience in clinical trial management
• Other requirements / knowledge : Excellent knowledge in the field of oncology, very good knowledge of the Good Clinical Practices and regulatory environment
• Languages spoken and written : French and English if based in the province of Quebec. English if based in any other Canadian province.
• Ability to travel

Intangibles (skills and attitudes)

• Excellent interpersonal skills
• Strong organizational skills and ability to handle competing priorities
• Strong communication (written and verbal) and presentation skills
• Ability to identify and solve problems
• Creativity
• Integrity / Honesty / Ethical behavior
• Passionate about our field of expertise
• Accountability
• Leadership
• Ability to supervise employees and manage their performance
• Flexibility
• Autonomy
30+ days ago