Allergan Senior Manager, CMO Trial Management in Buckinghamshire, United States
Senior Manager, CMO Trial Management
Buckinghamshire, England, United Kingdom at https://agn.referrals.selectminds.com/jobs/6212/other-jobs-matching/location-only
Aug 06, 2018Post Date
Under supervision of the Team Lead for Epidemiology Trial Management and applicable Epidemiologist, the Sr. Manager is responsible for the execution of required Phase IV initiatives. They are required to maintain current scientific knowledge relevant to assigned therapeutic areas and provide operational support for Phase IV trials and interface as required with CMO personnel, Epidemiology, Safety, Legal, Regulatory, and Clinical R&D. The role also involves managing activities of contract research organizations (CRO) and other appropriate external study execution partners and serve as the point for communication between Phase IV clinical trial sites and Allergan. The Sr. Manager is accountable to provide accurate trial cost and timeline forecasts based on assumptions provided by CMO Medical Directors and is expected to manage trial expense within agreed upon trial budget parameters and maintains a high degree of awareness of assigned trial status, costs and timelines. They maintain updated trial records in electronic clinical trial management system (CTMS) and other required systems as well as provide study updates upon request to business partners and as required by team lead or Epidemiology. The Sr. Manager analyses program productivity by tracking performance vs. quarterly forecasts and agreed upon milestones and is expected to maintain and demonstrate currency with all applicable Allergan policies and Compliance requirements as well as Good Clinical Practice (GCP).
Responsiblefor the operational execution of assigned Phase 4 studies.
Providedue diligence of CRO capabilities and manages relationship with externalvendors in successful completion of research programs.
Ensurestudy support is consistent with product strategy and corporate complianceguidance. Manages development of clinical data by conducting prospectiveclinical trials and retrospective analyses of study data.
Coordinatestudy-related activities as needed with internal stakeholders and partners toinitiate and successfully complete clinical trials with the goal of highestclinical science and integrity and for the maximum benefit of the company.
Adhereto GMP standards for the conduct of trials.Tracks programs vs. plans and benchmarks productivity.
Maintaina customer focus that includes effective working relationships with internaland external study stakeholders, including CMO personnel and allied Allergandepartments.
Coordinateand support publications and required registry postings.
Proactivelyand reactively communicates trial updates and challenges to stakeholders.
Maintainsa strong connection with investigator sites.
Establishand maintain currency with all required Allergan, GCP, and health authoritypolicies and procedures. Provides accurate and timely budget forecasts asrequired for assigned trials.
Education and Experience
Bachelorof Science degree or equivalent and extensive experience in pharmaceuticalindustry or related health care research/education/marketing experience OR MSand some experience of pharmaceutical industry or related health careresearch/education/marketing experience required; advanced training (e.g. PHDor PharmD) preferred
ClinicalResearch or Strategic Marketing experience required; an emphasis ininjectibles/toxins is desired
Epi/PASSexperience highly preferred
Essential Skills and Abilities
Demonstratedtechnical skills and ability to understand and communicate clinical studies
Solidcommunication skills, both oral and written, with proven ability to effectivelypresent to audiences of varying levels
Priorexperience in Phase III or IV clinical research required
Demonstratedability to work effectively with others in a matrixed environment
Provenability to manage multiple projects and product responsibilities
Demonstratedunderstanding of and adherence to compliance guidelines
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.