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Added 6 mins ago
CO
Director, Health, Safety, & Organizational Resilience
City of Saint John
Saint John, NB
- Full-time
…necessary for sustainable adoption of new policies, practices, systems, and…
Added 6 mins ago
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- Full-time
Experience working with large datasets, actuarial systems, and complex analytical environments
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- Full-time
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- Full-time
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- Full-time
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Added 37 mins ago
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RI-MUHC | Research Institute of the MUHC | #rimuhc
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Closed listing

Elpida Therapeutics

Clinical Project Manager - Gene Therapy Clinical Trials

Canada

Contract

This opening has closed.

The original listing is kept below for reference.

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About employer

Job details

Job type: Contract
Experience: 3-5 years of project coordination or project management experience in biotech, pharma, or a CRO.
Posting language: English
Posted: Sep 28, 2026

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Original job description

Archived listing. The details below describe a past opening.

Location: Canada [Remote/Hybrid]

Employment Type: Full-time

Job Description

We are a non-profit biotechnology company focused on developing gene therapies for serious rare diseases with significant unmet medical need. We are seeking an organized, proactive Clinical Project Manager with clinical trial experience to join our growing team.

This role will be responsible for driving day-to-day clinical project activities across multiple studies and programs, working closely with internal team members, clinical sites, vendors, investigators, and external partners. The ideal candidate is comfortable working independently in a fast-paced environment, takes ownership of deliverables, and proactively identifies and escalates risks.

**Please do not apply if you do not have clinical trial experience**

**No agencies please**

**Please provide salary expectations**

Key Responsibilities

· Own and maintain clinical project timelines, deliverables, action items, risks, and dependencies across assigned studies.

· Coordinate cross-functional clinical trial activities and ensure deliverables remain on schedule.

· Lead routine project-management follow-up with internal team members, clinical sites, vendors, and external partners.

· Identify upcoming deadlines, risks, delays, and operational issues and proactively escalate items requiring attention or decision.

· Prepare and lead routine project status updates, including completed activities, upcoming milestones, overdue items, risks, and decisions needed.

· Coordinate study documentation, including study manuals, trackers, logs, training documentation, and other trial-management tools.

· Manage and maintain essential clinical and regulatory documentation, including financial disclosure documentation, study documents, and Trial Master File (TMF) records.

· Coordinate regulatory and Research Ethics Board (REB) submissions and maintain associated documentation.

· Support Health Canada clinical trial activities and documentation, as applicable.

· Coordinate study start-up, ongoing study management, and closeout activities with sites and vendors.

· Manage study training documentation and ensure required training is completed and appropriately documented.

· Track vendor deliverables, timelines, outstanding actions, and performance.

· Monitor clinical data collection and work with data-management teams to support data quality, completeness, query resolution, and reconciliation.

· Review data-entry and data-cleaning status and escalate delays or outstanding issues.

· Assist with development and maintenance of data-management plans and study-specific data-management documentation, as applicable.

· Support audit and inspection readiness, including maintenance and review of essential project documentation.

· Develop and maintain project-management tools, templates, trackers, and processes to improve operational efficiency.

· Ensure activities are conducted in accordance with applicable regulations, ICH-GCP, company SOPs, and study-specific requirements.

Required Knowledge, Skills, And Abilities

· Strong knowledge of clinical research operations and Good Clinical Practice (GCP).

· Demonstrated ability to independently manage clinical project timelines, deliverables, risks, and competing priorities.

· Strong organizational and follow-through skills with excellent attention to detail.

· Ability to anticipate next steps and identify potential operational issues before they affect study timelines.

· Strong written and verbal communication skills.

· Ability to establish and maintain effective working relationships with cross-functional team members, investigators, clinical sites, vendors, and external partners.

· Experience with clinical trial systems such as EDC, CTMS, eTMF, REDCap, Veeva, Medidata Rave, or similar platforms.

· Familiarity with clinical data-cleaning, query-resolution, and reconciliation workflows.

· Understanding of common clinical trial data, including laboratory data, adverse events/serious adverse events, demographics, patient-reported outcomes, and other clinical assessments.

· Knowledge of applicable clinical research regulations and guidance, including Health Canada requirements and ICH-GCP.

· Familiarity with Health Canada Clinical Trial Applications (CTAs), Research Ethics Board processes, and Canadian clinical trial requirements is strongly preferred.

· Ability to work independently and effectively in a small, fast-paced, evolving organization.

· Ability to adapt quickly to changing priorities and take ownership of projects with limited day-to-day supervision.

Qualifications

Bachelor's degree in life sciences, public health, or a related field.
3-5 years of project coordination or project management experience in biotech, pharma, or a CRO.
Experience supporting gene therapy or rare disease clinical trials is a plus.
Familiarity with data management practices in clinical research (including EDC platforms)
Prior experience managing small to mid-sized clinical projects or serving as a key support role on larger trials.
Demonstrated ability to juggle multiple projects, prioritize tasks, and adapt to changing priorities.
Experience with Canadian clinical trials and Health Canada requirements is preferred.

We are an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

About employer

More about this job

Responsibilities

Manage timelines, deliverables, risks, documentation, and operational activities across clinical studies, coordinating with internal teams, sites, vendors, investigators, and external partners. Support study start-up through closeout, regulatory and ethics submissions, data quality, vendor performance, and audit readiness while ensuring compliance with applicable regulations and GCP.

Requirements

Requires a bachelor's degree in life sciences, public health, or a related field, along with 3–5 years of project coordination or management experience in biotech, pharma, or a CRO and clinical trial experience. Candidates should have strong knowledge of clinical research operations and GCP, familiarity with clinical trial systems and data workflows, and preferably experience with Canadian trials, Health Canada requirements, gene therapy, or rare diseases.

Skills

Clinical Trial Project Management
Clinical Research Operations
Good Clinical Practice
Project Timeline Management
Risk Management
Regulatory Submissions
Health Canada Requirements
Research Ethics Board Processes
Trial Master File Management
Clinical Data Management
Data Cleaning and Query Resolution
Vendor Management
Audit and Inspection Readiness
EDC, CTMS, and eTMF Systems
Cross-Functional Coordination
Gene Therapy Clinical Trials

Visa sponsorship

Not detected in the job text

Keywords

Clinical Trials
Gene Therapy
Rare Diseases
Clinical Project Management
Good Clinical Practice
ICH-GCP
Health Canada
Clinical Trial Applications
Research Ethics Board
Trial Master File
EDC
CTMS
eTMF
REDCap
Veeva
Medidata Rave
Clinical Data Management
Data Cleaning
Query Resolution
Data Reconciliation
Audit Readiness
Inspection Readiness
Study Start-Up
Study Closeout
Vendor Management
Regulatory Documentation
Adverse Events
Serious Adverse Events
Biotechnology

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