Project Director (Czechia)

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. 

Recruitment process: what to expect

• As part of the recruitment process for this position you will meet various team members at Indero
• The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour)

About Indero  

A Global Clinical Leader In Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

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 Czech Republic.