Clinical Trials Project Manager - lévis; Levis

Position: Clinical Trials Project Manager - lévis (Levis)
Location: Lévis

Clinical Trial Project Manager (Canada Only)

Location:

Remote (Canada)

Employment Type:

Contractor (Full Time Role)
Organization:
Elpida Therapeutics
Elpida Therapeutics is a nonprofit biotechnology organization dedicated to developing and delivering transformative therapies for children living with ultra-rare diseases. Founded by a parent who successfully helped develop a gene therapy to save his son, Elpida is redefining how therapies are brought to patients by combining philanthropy, science, and an unwavering commitment to families.
Today, Elpida is advancing multiple clinical‑stage gene therapy and antisense oligonucleotide (ASO) programs across North America and Europe. Our mission is easy: ensure that no child is left behind simply because their disease is considered too rare.

Position Overview  Elpida Therapeutics is seeking an experienced and highly motivated Clinical Trial Project Manager to oversee the planning, execution, and delivery of global clinical trials across multiple rare disease programs. This individual will serve as the operational leader responsible for ensuring studies are executed on time, within budget, and in compliance with all applicable regulatory and quality requirements. The successful candidate will work directly with investigators, hospitals, CROs, regulatory agencies, research coordinators, patient advocacy groups, and families to advance life‑changing therapies for children around the world.
This is a unique opportunity to play a direct role in helping bring treatments to patients while building an open‑science clinical development platform that can be leveraged by future rare disease programs.

Key Responsibilities  Clinical Trial Management   Lead day‑to‑day management of international clinical trials from study startup through closeout.
Develop and maintain project plans, timelines, budgets, risk registers, and study dashboards.
Ensure studies remain on schedule, within budget, and aligned with strategic objectives.
Identify and proactively mitigate project risks and operational challenges.
Coordinate activities across investigators, hospitals, CROs, laboratories, consultants, and vendors.
Lead regular study team meetings and provide updates to leadership.
Site Management & Clinical Operations   Coordinate site activation activities across multiple countries.
Support site feasibility assessments and startup activities.
Work directly with Principal Investigators, Sub‑Investigators, Research Coordinators, and site staff.
Manage site communications and ensure consistent execution across all participating hospitals.
Support monitoring activities and resolution of study issues.
Ensure sites remain compliant with protocol requirements and regulatory obligations.
Ethics & Regulatory Management   Coordinate submissions to Institutional Review Boards (IRBs), Research Ethics Boards (REBs), and Ethics Committees.
Track ethics approvals, renewals, amendments, and continuing reviews.
Support preparation and submission of documentation to Health Canada, FDA, EMA, MHRA, AIFA, and other regulatory authorities.
Coordinate responses to regulatory questions and requests.
Ensure regulatory commitments and timelines are met.
Patient Enrollment & Engagement   Develop and execute patient recruitment and enrollment strategies.
Track screening, enrollment, retention, and study participation metrics.
Work closely with patient advocacy organizations and family groups.
Serve as a key point of coordination between clinical sites and participating families.
Help improve patient and caregiver experience throughout the clinical trial process.
Support travel coordination and logistics when required.
Clinical Documentation   Clinical Protocols
Investigator Brochures (IBs)
Informed Consent Forms (ICFs)
Clinical Trial Applications (CTAs)
Regulatory briefing packages
Clinical Study Reports (CSRs)
Safety reports and annual reports
Trial Master File (TMF) documentation
Study manuals and operational plans
Standard Operating Procedures (SOPs)
Vendor & Budget Management   Manage CROs, consultants, laboratories, and external vendors.
Track vendor deliverables and performance metrics.
Review contracts, scopes of work, and budgets.
Monitor…