![]() briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc May support the Medical Expert on project documentation e.g. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raisedĪuthor of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Communicate study progress to CTT, CS&I Management, Therapeutic Area Heads and Project team members ![]() Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met. ![]() Your main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration Successful experience in working with globally operating matrix teams and in the coordination with various internal and external interfaces (academia, in-house labs and contracted vendors)Ĭlinical Scientist for Phase I/II including multi-country / multi-center trials.Understanding of the vaccine development process and experience with the support of clinical trial teams.Basic understanding of GMP, GCP-ICH and GCLP guidelines.flavivirus, alphaviruses, calicivirus) and vaccine development is desirable, as well as in immunology and molecular biology Strong communication, strategic, analytical problem-solving & interpersonal skills. ![]() Successful experience in working with globally operating matrix teams and in the coordination of various internal and external interfaces (academia, in-house labs, and contracted vendors).Understanding of the vaccine development process and experience with the support of clinical trial teams Basic understanding of GMP, GCP-ICH and GCLP guidelines.flavivirus, alphaviruses, calicivirus) and vaccine development desirable, as well as in immunology and molecular biology This includes experience and understanding in working with blood borne pathogens and human serum Experience and demonstrated success in the development and, validation and clinical sample testing by using serology assays and other bio-analytical methods.Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Interact with investigator sites and CRAs/CROs/vendors to ensure a smooth study set up and a smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Track record of successfully managing multiple concurrent global phase I and IIa, multi-country/site complex clinical trials.Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents.Business-level written and oral English.Used to working independently and in a team environment, being flexible and adapting to change.Used to working independently and in a team environment, being flexible and adapting in a changing environment. ![]()
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