In role your will be exposed to following tasks and responsibilities within range of Gastroenterology and Internal Medicine development projects.
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Setting up, documenting and communicating project specific medical monitoring requirements for assigned projects.
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Supporting medical monitors under medical guidance in the conduct of studies
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Developing and reviewing medical monitoring and other study related plans
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Training project team and sites in the protocols
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Reviewing site and project team queries
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Reviewing medical data including labs, patient profiles, CRF data and eligibility/enrollment reviews
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Assisting Medical Monitors in business development
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Performs scientific research for and provides input into the RFP
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Conducting medical data review and generates data queries
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Ensuring compliance with and adherence to all internationally recognized standards
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Initiating medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements
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Reviewing budget and scope of medical team's responsibilities addressing inadequacies or concerns with the Medical Director and/or project management team
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Tracking study progress, proactively resolves issues, and proposing corrective action to project team/clients
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Processing and addressing protocol non-compliances at Investigative sites and ensuring adherence to ethical guidelines
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Collaborating with Medical Directors on the medical-operational aspects of complex clinical studies
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Attending Investigator Meetings and interacting with Investigative site staff and client representatives
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Is a point of contact and knowledge resource for Medical Directors to consult with on study-specific drug/device medical activities
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Preparing for audits and inspections by sponsors or regulatory agencies
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Reviewing and QCing documents and work of other associates, as needed
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Mentoring other more junior members of the team
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Supporting PV activities as needed
Education and experience requirements:
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Graduate in medicine
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Ideally, previous clinical practice experience in Gastroenterology or Internal Medicine, (Board certification or equivalent not required).
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CRO experience is preferred
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Knowledge of ICH / GCP regulations
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Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
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Fluent verbal and written English as well as the local language(s)
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Excellent team player, collaborative and able to build an effective team
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Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
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Maintains a positive, results orientated work environment