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.
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.
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, 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%).