Sr Clinical Scientist

Primary Role:

Responsible for the planning, implementation, execution and management of clinical research studies. Manages clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs, etc. Authors protocols, informed consent forms and study related plans developed by Shire. Responsible for the financial and budgetary aspects of a study.

Responsibilities:

10% - Leads the study team to design, develop and deliver the clinical study; Authors protocols, ICFs and study related plans developed by Shire; May contribute to the clinical development strategy of R&D projects40% - Responsible for the clinical review and approval of Case Report Forms (electronic as applicable) and provides clinical input into corresponding completion guidelines; Responsible for identification and selection of investigator sites; Responsible for planning and conducting investigator's meetings. May present information at the meeting; Provides input and coordinates the on-schedule delivery of clinical trial supplies in collaboration with Pharmaceutical Sciences; Collaborates on selection and management of IVRS vendor; Liaising and coordinate with document specialists regarding study files40% - Oversees the management of CRO activities and other clinical vendors to ensure the quality is consistent with Shire requirements; Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required; Oversees and monitors the management of clinical studies, which includes review and approval of a Clinical Monitoring Plan, by regular investigator site / CRO / clinical vendor contact; Reviews correspondence, monitoring reports relating to the study5% - Develops and monitors budget for clinical development program and may negotiate budgets and contracts with CROs, investigative sites (as applicable) and vendors; Requests and assesses proposals from CROs and other vendors; Leads team through selection process and provides input into contracts and/or work orders5% - Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities; May mentor other Study Managers

Education & Experience:

Bachelor's degree or nursing qualification is required. Scientific/health care field preferred, but not requiredGenerally varied experience in clinical research within a pharmaceutical company or CRO or similar organizationMust be able to create protocols, informed consents and study related plansStrong knowledge of MS Word, Excel, PowerPoint, Project and OutlookWorking knowledge of project management software or toolsExperience in financial budgeting, forecasting and reportingAbility to independently resolve problemsRequires strong attention to detail and the ability to establish priorities, schedule and meet deadlinesAbility to work successfully within a cross-functional team and a matrix organisationGood written and oral communication skillsDisplays a high level of professionalism with vendors, external contacts and individuals at all levels of the organizationMust be able to independently present complex information to Shire management, CROs and the medical communityProven ability to manage and communicate effectively with research vendors including negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaintsMust be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demandsAbility to work independently, take initiative and complete tasks to deadlines