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
Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.
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.

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.
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%).

Global Study Manager – Sponsor-dedicated

Key skills