Description
RESPONSIBILITIES:* Accountable for operational oversite of clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements
* Member of the Study Management Team (SMT)
* Facilitates SMT Meeting, responsible for the timely setting of agendas, effective conduct of SMT meetings and timely issuance of meeting minutes
* Facilitates in all operational activities pertaining to the execution of clinical trials
* Maintains regular internal contact with relevant departments such as Regulatory Affairs, Drug Safety and others as necessary.
* Attending meetings for project kick-off with the CROs; investigator meetings, assuring investigators and site coordinators are well trained on the study; and attending project team meetings throughout the study.
* Visits the CROs to interact with their functional teams and review the study files.
* Trains CROs on the protocol.
* Monitors CRO performance to assure protocol compliance.
* Assists in the selection and initiation of sites.
* May visit clinical sites to establish direct company contact with investigators and their study personnel, and to evaluate the work they are doing on the trial.
* Updates Clinical Trial Management System (CTMS), and ensures completion of systems and tools to enable successful trial execution and reporting
* Responsible for overall study project management of clinical studies including projection and management of study timelines
* Creation and management of clinical trial budgets, in conjunction with Development
* Assists Assoc. Director/Director, Clinical Operations in the development of staffing/resourcing plans
* Where appropriate, may act as Designee for Assoc. Director/Director, Clinical Operations
* Provides input for definition of new or revised process development, problem solving, training, etc., as needed.
* In conjunction with CRO, may attend initiation, routine site visits, and close-out visits.
* Travel is required in the United States up to 20% and internationally (on an "as needed basis") in support of CRO activities
EDUCATION/EXPERIENCE/SKILLS:
Education:
* BS/BA degree in related discipline and eight years of related experience; or,
* Advanced degree in related discipline and six years of related experience; or,
* Equivalent combination of education and experience.
* May require certification in assigned area.
Experience:
* Typically requires a minimum of twelve years of related experience and/or combination of experience and education/training.
* At least three years experience in study management is preferred, or equivalent experience gathered in a previous Clinical Trials Management role
* Experience in management of multiple sites as a Clinical Research Associate is preferred.
Knowledge/Skills/Abilities:
* Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States.
* Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
* Exhibits ability to learn and apply foreign regulations to the clinical trial/research process.
* Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
* Oncology therapeutic area knowledge essential
* Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally
* Organizes and prioritizes numerous tasks and completes them under time constraints.
* Frequently applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques.
* Resolves a wide range of issues in creative ways.