JOB SUMMARY The position provides customer focused leadership in managing and delivering the operational and financial aspects of one or more clinical projects from proposal development to final deliverables and ranging in size and complexity from single service studies to full scope, multiple protocol projects and/or global projects across various phases and functional areas with limited interaction from supervisor. May oversee less experienced Project Managers (PMs) and have line management responsibilities.
Project Leadership and Delivery:
- Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
- Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
- Leads clinical team to ensure quality, timelines and budget management .
- Accountable for all project deliverables for assigned projects and/or project regions.
- Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.
Reporting and Communication:
- Accountable for maintenance of project information on a variety of databases and systems.
- Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
- Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files.
- Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
- Independently prepares, coordinates, and presents project material at internal and external meetings.
- Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication.
- Prepares project management reports for clients and management.
- Implements resource strategies to achieve project goals.
- Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.
- Participates in bid defense meetings where presented as potential project manager/director.
- Develops strong relationships with current clients to generate new and/or add-on business for the future.
- Keeps a current awareness of business unit's and assigned projects' therapeutic environment and drug development trends
- May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
- May be required to line manage other project management team members and clinical monitoring staff
- Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
- Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures.
- Clinical research organization (CRO) and relevant therapeutic experience preferred.
- Strong ability to manage time and work independently.
- Ability to embrace new technologies.
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
- 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.