ABOUT ALETHIA BIOTHERAPEUTICS

Alethia Biotherapeutics is a Montréal-based clinical-stage oncology biotech. Our lead asset, sotevtamab (AB-16B5), is a monoclonal antibody targeting tumor resistance mechanisms, notably epithelial-to-mesenchymal transition (EMT), thereby enabling existing immunotherapies to become significantly more effective. We do not replace current treatments: we enhance their efficacy.

We are at a pivotal stage of our development, with a strategic plan actively being executed and key structuring decisions to be made in the coming months. Those who join Alethia now are contributing to building an organization that matters.

ROLE CONTEXT

The Clinical Trial Manager (CTM) is the operational backbone of Alethia’s clinical program. Reporting directly to the VP, Drug Development, this role carries full responsibility for the day-to-day execution of our Phase 2 clinical studies (two planned, with more to come) from site activation through to close-out.

This role is built for someone who is equally comfortable writing a monitoring plan and driving out to visit a site. You will manage two direct reports (CRAs – Clinical Research Associates) and a network of external partners, investigators, CROs (Contract Research Organizations) and central labs, while maintaining the documentation standards that make our studies inspection-ready at all times. Scope is real, ownership is real, and your work will be visible at the leadership level from day one.

Alethia is a team of approximately 15 people. This is not a coordination role inside a large organization. It is a role where you lead, write, decide, and execute, sometimes all in the same day.

This role requires full bilingualism, spoken and written (French and English).

KEY RESPONSIBILITIES

Trial Execution & Site Management

• Lead the operational execution of Phase 2 clinical studies from start-up through close-out, across all assigned sites

• Plan and conduct site qualification, initiation, monitoring (on-site and remote), and close-out visits

• Manage site performance: enrollment tracking, protocol deviation follow-up, and issue escalation

• Serve as the escalation point and senior contact for investigators, study coordinators, and site staff, with CRAs managing day-to-day site communication

• Support site regulatory submissions and ethics board approvals in collaboration with regulatory affairs

CRO & Vendor Oversight

• Manage day-to-day relationships with CROs and other clinical vendors

• Provide operational coordination with central labs and interactive response technology providers (IRT/IVRS), in support of the VP, Drug Development





• Ensure sponsor oversight compliance per ICH E6(R2), the Good Clinical Practice (GCP) guideline: review monitoring reports, track action items, escalate deviations

• Participate in vendor selection, contract review, and clinical study budget management as required

• Hold CROs accountable to contractual milestones and quality standards

• Coordinate investigational product shipment logistics to clinical sites

Documentation & eTMF

• Own the Electronic Trial Master File (eTMF): completeness, accuracy, and inspection-readiness at all times

• Oversee EDC/IWRS system configuration and setup for each study, in collaboration with vendors

• Write and maintain key study documents: monitoring plan, site management plan, communication plans, and visit reports

• Oversee collection and review of site regulatory documents (ethics approvals, investigator CVs, delegation logs, Informed Consent Forms (ICFs))

• Maintain and update clinical trial registry entries (ClinicalTrials.gov and Health Canada equivalents)

Data Integrity & Pharmacovigilance

• Ensure source data verification (SDV/SDR) is performed per the monitoring plan

• Monitor Electronic Data Capture (EDC) system data entry quality and query resolution across all sites

• Verify that adverse events (AEs) and reliable adverse events (SAEs) are correctly coded, documented, and reported within regulatory timelines

• Confirm informed consent is obtained, documented, and current for every participant

Quality, Compliance & Risk Management

• Ensure study compliance with ICH/GCP guidelines and Health Canada and FDA regulatory requirements

• Manage protocol deviations: identification, documentation, Corrective and Preventive Action (CAPA) development and follow-through

• Proactively identify and escalate operational risks to the VP, Drug Development, with proposed mitigations, not just flags

• Contribute to Standard Operating Procedure (SOP) development and maintenance for clinical operations

• Support audit and inspection readiness across all study documentation

Cross-functional Collaboration

• Liaise with the CMC (Chemistry, Manufacturing, and Controls) team on investigational product matters

• Collaborate with the QA Manager on GCP compliance,



deviation management, and inspection preparation

• Represent Alethia at investigator meetings and relevant regulatory interactions

• Contribute clinical operations content to partnership documents, data rooms, and investor materials as needed

QUALIFICATIONS

Education

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline (required); graduate training in clinical research an asset

Experience

• Minimum 7 years of experience in clinical trial operations in pharma, biotech, or a CRO environment (5-6 years considered for candidates with particularly strong oncology or small-biotech experience)

• Demonstrated experience managing Phase 1 or 2 oncology trials, ideally within a small or mid-size biotech

• Experience directly managing CROs and clinical vendors (oversight, performance accountability)

• Proven ability to write clinical documents (monitoring plans, visit reports, deviation summaries, site communications)

• Experience managing or mentoring junior clinical staff (CRAs or CTAs – Clinical Trial Assistants) an asset

• ACRP – Association of Clinical Research Professionals (CCRC or CCRA) or SOCRA – Society of Clinical Research Associates (CCRP) certification an asset

Skills and Competencies

• Thorough knowledge of ICH E6(R2) GCP guidelines and Health Canada and FDA regulatory requirements

• Experience with EDC systems (Medidata Rave, Veeva Vault EDC, or equivalent)

• Experience with electronic TMF systems (Veeva Vault, Trial Interactive, or equivalent)

• Availability for occasional travel to investigator sites as needed

• Organized, proactive, and highly accountable, able to manage multiple workstreams without close supervision

WHAT WE OFFER

Joining Alethia as our Clinical Trial Manager means owning the operational execution of Phase 2 oncology studies at a decisive moment in the program’s development. This is not a support role: it is a leadership role in a small organization where your contribution will be felt immediately, by the team, the investigators, and ultimately the patients.

• Permanent, full-time position

• Hybrid work arrangement, Montréal

• Competitive annual salary commensurate with experience

• Group benefits and RRSP with employer contribution

• Direct impact on advancing a clinical-stage oncology asset

• Start date: as soon as possible

HOW TO APPLY

Please submit your CV and a brief cover note to:

Subject line: CLINICAL TRIAL MANAGER, FIRST NAME LAST NAME

Only candidates selected for an interview will be contacted.

📌 Clinical Trial Manager (Laval)
🏢 Alethia Biotherapeutics ULC
📍 Laval