Clinical Trial Manager
ProClinical is working with a global biotechnology company that is seeking a Clinical Trial Manager to be based in Berkshire on a contract basis. The Clinical Trial Manager is responsible for the global/regional clinical study planning and execution within pre- specified program plan, timelines and budget and includes, but is not limited to, participation in the preparation of study related materials, relationship management between study sites and vendors; in particular CRO(s), participation in the supervision of study related activities, identification of project risks and contingency planning. Job Responsibilities * Manage project team activities; leveraging internal resources, expertise and knowledge * Execution of clinical trials from protocol design to the final clinical study report. * Manage aspects of CRO outsourcing, including: , request for proposal development, CRO selection process, and the day to day study management activities of CROs. * Participate in the management of study sites and tracking systems for regulatory documents, CRO monitor visit reports and site correspondence, drug supply and use, enrolment of subjects, study timelines, financial information, Serious Adverse Events, performance metrics, data flow, etc. * Participate in Case Report Form design, user acceptance testing in partnership with data management. * Participate in template Informed Consent Form development, and review of site ICFs * Involvement in discussion and help develop contingency/risk management plans for projects and assist Manager, Clinical Operations, Director of Clinical Operations in the preparation and execution of sound development strategies. * Create, track, and manage project budgets and timelines with an ability to provide comparison updates of financial accruals versus projected budgets. * Interface with Regulatory Affairs, Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs. * Review and approve vendor invoices for payment. * Ability to travel (no more than annual average of 25%). Skills and Requirements: * Bachelor's Degree is required. An advanced degree in scientific discipline, business/finance courses is preferred. * 3+ years of clinical project management experience gained within a CRO or Pharmaceutical Company working on Phase I - IV multinational clinical studies. Later stage clinical study experience a plus. * Regulatory and compliance knowledge, including Good Clinical Practices (GCPs) * Strong organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability. * Excellent communication skills (written and verbal), along with presentation skills. * Knowledge of global clinical trial management. Ability to work with a team to assemble a plan yet execute on the details. * Protocol, ICF, CRF, CSR design and revieTo Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Jack O'Neill on +44 203 846 0646 or upload your CV on our website - www.proclinical.com. A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.