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Clinical Trial Project Leader

3 months ago

Canada Innovaderm Research Full time

Role Overview

As a Clinical Trial Project Leader at Innovaderm, you will play a pivotal role in the success of our clinical research initiatives. Acting as the primary liaison for both internal teams and external stakeholders, you will ensure that all project activities and deliverables are executed efficiently, adhering to timelines and budgetary constraints.

Key Responsibilities

Client Engagement

  • Act as the main point of contact for sponsors.
  • Deliver timely updates regarding trial progress.

Project Management

  • Lead the development of essential project documents, including study plans, protocols, informed consent forms, and clinical study reports.
  • Facilitate the planning and execution of Investigator's Meetings.
  • Ensure that all sites are equipped with necessary materials for effective study execution.
  • Generate detailed site visit reports and monitoring tools.

Quality Assurance and Risk Management

  • Oversee clinical monitoring processes to ensure high-quality deliverables.
  • Identify and address issues related to study quality and vendor performance.
  • Implement risk management strategies to maintain project integrity.
  • Conduct analyses of discrepancies between planned and actual outcomes.

Budget and Timeline Oversight

  • Manage project budgets, focusing on resource allocation and internal hours.
  • Identify out-of-scope activities for potential change orders.
  • Proactively oversee operational aspects of clinical trials, including timelines and vendor coordination.
  • Communicate effectively with all project stakeholders regarding recruitment status and necessary initiatives.

Team Leadership

  • Ensure comprehensive training for all project team members.
  • Collaborate closely with vendors and internal departments to meet project objectives.
  • Conduct project-specific training sessions for Clinical Research Associates (CRAs).

Candidate Profile

Education

  • Bachelor's degree in a relevant field related to clinical research.
  • Master's degree or Ph.D. is an advantage.

Experience

  • 5-7 years of experience in the industry, with at least 3 years in managing Phase I-II clinical trials.
  • Experience with multi-centered clinical trials across various regions is beneficial.
  • Familiarity with study start-up, regulatory submissions, clinical monitoring, or vendor management is an asset.
  • Experience in dermatology trials is a plus.

Skills and Knowledge

  • In-depth understanding of GCP and ICH guidelines, as well as FDA and local regulations.
  • Proficient in Microsoft Office Suite.
  • Fluent in English with strong verbal and written communication skills; bilingualism in English and French is advantageous.
  • Ability to foster teamwork and build strong relationships with colleagues and sponsors.
  • Strong problem-solving and analytical skills, with the capacity to work under pressure while meeting deadlines.

About Innovaderm

Innovaderm is a leading contract research organization (CRO) specializing in dermatology. Since our inception in 2000, we have established a reputation for delivering high-quality research services that exceed client expectations. Our Montreal-based team continues to expand its footprint across North America and Europe, driven by our core values of collaboration, innovation, reliability, and responsiveness.