Senior Project Manager – Clinical Trial Manager, Oncology
Job Description: • 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. • 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. Requirements: • 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%). Benefits: • company car or car allowance • Health benefits to include Medical, Dental and Vision • Company match 401k • eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • flexible paid time off (PTO) and sick time Apply tot his job