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 the financial performance of assigned projects
• 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.

Business Development

• 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

Management

• 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

Qualifications

What we’re looking for;

• 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 and other applicable regulatory requirements.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.
• Prior experience as Project Lead is required.
• Direct therapeutic area expertise.
• Strong ability to manage time and work independently.
• Strong organizational skills.
• 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 (less than 25%).