Offer summary

Qualifications:

Bachelor's degree in a relevant discipline; a Master's degree is a plus., At least 15 years of industry experience, including 5 years at a CRO., Minimum of 10 years in clinical project management across all project phases., Knowledge of good clinical practices, FDA, and Health Canada regulations..

Key responsibilities:

Oversee a portfolio of clinical studies and manage Project Managers.

Ensure studies meet therapeutic, client, and regulatory requirements.

Represent the company to clients and maintain satisfaction levels.

Lead operational activities, including proposal development and risk mitigation.

Job description

Description

The Project Director is responsible for oversight of the conduct of a program or portfolio of clinical studies or large global multicentered trials with large study budgets. The portfolio may comprise studies for specific customers, and/or a group of studies within the same therapeutic area or indication for more than one customer. The Project Director oversees Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or portfolio of projects. The Project Director leads the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic and project management expertise

This role will be perfect for you if:

You are looking to contribute your expertise to the growth of a specialized CRO
You are a hands-on leader
You want to be involved in program management as well as line management

RESPONSIBILITIES

Oversees a portfolio or program of projects and the Project Managers assigned to operationalize the awarded studies.
Ensures all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
Represents company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations.
Oversees the management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
Ensures and maintains an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
Applies study specific learning across assigned portfolio of studies/clients.
Leads and ensures consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
May lead operational input to proposal development and pricing including proposed operations strategy
Drives performance improvement, operational efficiencies and innovative strategies
May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert

Requirements

IDEAL PROFILE

Education

Bachelor of Science in a relevant discipline.
A Master’s degree is an asset.
PMP or PRINCE2 Certification is an asset

Experience

At least 15 years industry experience and a minimum of 5 years at a CRO
At least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable.
Experience leading concurrent multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting
Substantial experience in project supervision, mentoring and coaching project managers
Substantial experience with business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like
Participation in mentoring and coaching of a representative number of project managers
Line management experience is desirable
Dermatology experience is an asset

Knowledge and skills

Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines

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 / work schedule :
Home-based position
Ongoing learning and development

About Indero

Indero is 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 Argentina

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