The position is responsible for oversight of the conduct of a program or portfolio of clinical studies.
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.
Provides oversight to 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. This includes managing the scope of work, objectives, quality deliverables, resources, risks and other project management activities.
The Project Director may also lead the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic expertise.
- Oversee a portfolio or program of projects.
- Ensure all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
- Represent 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.
- Manages 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.
- Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
- Apply study specific learning across assigned portfolio of studies/clients.
- Lead and ensure 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
- Drive 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
- BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience.
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements, i.e. GPP
- Strong organizational skills.
- Strong ability to manage time and work independently.
- Direct therapeutic area expertise.
- Proficiency with full MS Office Applications, including MS Project
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Ability to travel as necessary (approximately 25%)
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Job Clinical Project Management
Travel Yes, 25 % of the Time
Employee Status Regular