The position providescustomer focused leadership in managing and delivering the operational andfinancial aspects of one or more clinical projects from proposal development tofinal deliverables and ranging in size and complexity from single servicestudies to full scope, multiple protocol projects and / or global projects acrossvarious phases and functional areas with limited interaction from supervisor.
May oversee less experienced Project Managers (PMs) and have line managementresponsibilities.
ProjectLeadership and Delivery :
Manages a project as Project Manager overseeing interdisciplinaryclinical research programs ensuring compliance with Good Clinical Practices (GCPs),relevant Standard Operating Procedures (SOPs) and regulatory requirements.
Acts as primary liaison between the Companyand the Customer to ensure project launch, conduct, and closeout according tothe 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 / orproject regions.
Coordinates activities and deliverables of all project conduct partnersand proactively identifies and manages issues.
Reportingand Communication :
Accountable for maintenance of project information on a variety ofdatabases and systems.
Maintains and evaluates project progress by maintaining timelines andother tracking / analysis tools.
Responsible for project management components of inspection readinessfor 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 atinternal and external meetings.
Directs the activities of assigned Project Support staff; line managesand mentors other project management team members and clinicalstaff;
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 ensuresuccessful delivery of project goals.
Participates in bid defense meetings where presented as potentialproject manager / director.
Develops strong relationships with currentclients to generate new and / or add-on business for the future.
Keeps a current awareness of businessunit’s and assigned projects’ therapeutic environment and drug developmenttrends
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 requiredto line manage other project management team members and clinical monitoringstaff
Bachelor’s Degree (or equivalent) level of qualification inlife sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
Strong knowledge of Good Clinical Practice / ICH guidelines, regulatoryrequirements, 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, bothwritten and spoken.
Flexibility and the ability to mentor and manage new staff and to handlemultiple tasks to meet deadlines delivering high quality work in a dynamicenvironment.
Ability to travelas necessary (approximately 25%).