Description
SUMMARY:The Sr. Clinical Trials Manager is accountable for the day-to-day operational oversight of 1-4 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. This activity is coordinated in conjunction with one or more CROs/vendors. Oncology experience is required. Mentoring and support of junior Clinical Operations staff is expected.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* 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
o Projection and management of study timelines
o Creation and management of clinical trial budgets, in conjunction with Development Outsourcing
o Ensures timely reporting of suitable Study Metrics to management
* 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
SUPERVISORY RESPONSIBILITIES:
* No immediate line management responsibility
* Requirement for mentoring and support of junior Clinical Operations staff (for example, Clinical Research Associate)
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.
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