Clinical Trials Project Manager (Waterloo)

Clinical Trial Project Manager (Canada Only)

Location: Remote (Canada)

Organization: Elpida Therapeutics

Employment Type: Contractor (Full Time Role)

About 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

Oversee the development, review, maintenance, and publication of key study documents, including:

• 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 study expenditures and financial forecasts.
• Ensure project resources are utilized efficiently.

Open Science & Knowledge Sharing

• Develop reusable clinical trial templates, SOPs, workflows, and operational frameworks.
• Organize and publish non‑confidential study materials through Elpida’s knowledge‑sharing portal.
• Create resources that can be leveraged by future rare disease organizations.
• Work with partners such as Conscience and other open‑science initiatives.
• Capture lessons learned and best practices from clinical development activities.
• Help establish a scalable framework for nonprofit‑led drug development.

Qualifications

Required

• Minimum 5 years of experience in clinical trial management or clinical operations.
• Strong understanding of ICH‑GCP and clinical research regulations.
• Experience working with investigators, hospitals, CROs, and regulatory agencies.
• Experience managing study timelines, budgets, and vendors.
• Excellent communication and organizational skills.
• Ability to manage multiple projects simultaneously.
• Legally authorized to work in Canada.

Preferred

• Experience in rare diseases.
• Experience in gene therapy, cell therapy, or ASO development.
• Experience supporting Health Canada, FDA, EMA, or MHRA submissions.
• Experience working with patient advocacy organizations.
• PMP, CCRP, CCRA, or similar certification.
• Speak Spanish.

Why Join Elpida?

• Help bring life‑changing therapies to children with devastating rare diseases.
• Work directly with leading clinicians, hospitals, and researchers around the world.
• Be part of one of the most innovative nonprofit drug development organizations in the rare disease space.
• Build clinical infrastructure that will impact future patient communities.
• Join a mission‑driven team where your work has a direct and measurable impact on patients and families.

We encourage candidates from diverse backgrounds who are passionate about helping patients and families affected by rare diseases.