Job Description

The Medical Project Director is responsible for planning, coordinating, and overseeing medical operations activities across clinical studies within Indero. This role ensures alignment between medical affairs and operational functions and drives execution of medical deliverables including eligibility, medical safety and efficacy review cycles, safety and efficacy oversight workflows, training plans, and inspection readiness.

The Medical Project Director serves as the operational backbone to the Medical Monitors and Independent Medical Reviewers and supports high-quality, compliant clinical trial execution in accordance with ICH-GCP and global regulatory requirements.

The Medical Project Director will coordinate Indero’s data quality metrics across studies and indications, operating at the intersection of medical, biostatistics/data management, central monitoring, and clinical operations. The role will translate historical and ongoing trial data into actionable insights, tools, and governance that strengthen site selection, protect signal integrity (including endpoint variability considerations where appropriate), and improve trial outcomes.

This position is designed as a strategic ‘glue’ function that builds repeatable frameworks and sponsor-facing differentiation, while ensuring methods and decisions remain defensible and aligned with applicable quality and compliance expectations.

This role will be perfect for you if

• You are a hands‑on leader with 10+ years of clinical research experience, including managing all project phases and cross‑functional deliverables.
• You bring strong expertise in clinical project management, vendor oversight, and medical/operational coordination within a CRO, biotech, or pharma environment.
• You have experience in dermatology or rheumatology trials, and you’re motivated to contribute to the growth of a specialized CRO through a strategic, collaborative approach.

RESPONSIBILITIES



Project Leadership & Coordination

• Lead end-to-end planning and tracking of medical deliverables across clinical studies.
• Develop and maintain medical operations project plans, timelines, and risk mitigation strategies.
• Coordinate medical input into study documents: protocols, amendments, medical monitoring plans, safety management plans, and training materials.
• Ensure medical affairs activities are harmonized with cross-functional timelines.

Medical Review & Oversight Support

• Oversee scheduling and execution of MM/IMR review cycles
• Track medical escalations and coordinate with MMs/IMRs to ensure timely resolution.
• Support development of medical data review tools, trackers, and dashboards.

Compliance, Quality, and Inspection Readiness

• Ensure medical oversight processes adhere to ICH-GCP, GVP, FDA/EMA, and internal SOPs.
• Coordinate medical involvement in audits and inspections; support CAPA development and closure.
• Maintain inspection-ready documentation for all medical oversight activities.
• Drive continuous improvement initiatives to optimize medical operations processes.

Cross-Functional Collaboration

• Serve as the liaison between medical affairs and other internal functions, and potentially sponsors, to secure operational excellence in acquiring data of high quality.
• Participate in internal meetings and present updates on medical operations deliverables.
• Engage with external vendors to align medical/IMR workflows.

Training & Communication

• Develop and coordinate medical training materials for internal teams, sites, and vendors.
• Maintain version control and distribution of medical documents and guidance.
• Facilitate communication pathways for medical clarifications, protocol questions, and safety escalations.

Budget & Resource Management

• Track medical affairs department operations budgets.
• Support forecasting of medical affairs resourcing needs and support workload allocation.

Requirements

IDEAL PROFILE

Education

• Bachelor of Science in a relevant discipline.

Experience

• 10+ years of experience in clinical research within a CRO, biotech, or pharmaceutical company.
• 5+ years of proven experience in project management, clinical operations, or medical operations.
• Strong familiarity with ICH-GCP, global regulatory requirements, and clinical development processes.
• Experience with medical monitoring workflows is a strong asset.

Knowledge and skills

Skills

• Outstanding project management and organizational skills.
• Ability to synthesize medical/scientific information and operationalize it effectively.
• Excellent communication skills (verbal, written, presentation).
• Proficiency with EDC, CTMS, eTMF, and safety database platforms.
• Strength in building cross-functional relationships and influencing without authority.
• High attention to detail and strong problem-solving capability.

Core Competencies

• Execution excellence and operational rigor
• Strategic thinking applied to medical workflows
• Risk identification and proactive mitigation
• Stakeholder and sponsor management
• Adaptability in a fast-paced, matrixed environment
• Quality mindset and continuous improvement orientation

Our company

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule
• Permanent full-time position
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Ongoing learning and development

Work location

The successful candidate for this position is given the option to work from home anywhere in Canada, or from our headquarters in Montreal (in accordance with company policies and public health directives).

Occasional visits to our Montreal headquarters may be required or encouraged.

About Indero

Inderois a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.

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Profil recherché

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Notre entreprise

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