Senior Clinical Operations Lead

Overview A global biopharmaceutical company on a mission to Solve On Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery development and commercialization of proprietary therapeutics Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology Oncology and Inflammation and Autoimmunity Headquartered in Wilmington Delaware Incyte has operations in North America Europe and Asia. Job Summary Primary function The Senior Clinical Operations Lead will be responsible to support the Clinical Trial Manageroperational team in execution of the trials. The function could include direct liaison with CROs and other ancillary vendors as appropriate to manage relevant trials operational tasks. Maintain effective communication with project team through oral and written correspondence status reports to ensure alignment with study timelines. Essential Functions of the Job Key responsibilities · Assists in the review development and writing of clinical trial documents and manuals including but not limited to study manuals laboratory or biomarker plans and other supporting documents. · Create Master ICF template and reviewapprove site changes in consultation with legal safety when warranted. Update template for new risks and new amendments information. · Participate in the feasibility and evaluation of investigative sites working closing with the Clinical Trial Logistics group. · Coordinate and monitor activities at investigational sites review monitoring trip reports and support the US monitoring organization. · Assist in the development and management of study timelines and priorities including recruitment toolsstrategy and patient retentions plan. · Plan and organize meetings with team support eg. investigatorcoordinator meetings DMC SMC safety call etc.. · Assist in the development of the IP and co-medication strategy Quantities labels depots tracking etc. working closely with other departments. · Participate in data review and discrepancy resolution. · Participate in coordinating efforts with internal Pharmacovigilance and safety group. · Monitor study-specific timelines and key deliverables focus on management of all external vendors e.g Monitoring Sample management IVRS Laboratory etc. · Participate as a member of the multi-disciplinary trials team. · Develop relationships with investigational sites and institutions to enhance conduct of the trial. · Acts as preliminary liaison for study sites to convey trial information answer questions and in accordance with the escalation pathway. · Assume responsibility to participate as a member of a working group and perform special projects as assigned to improve the efficiency effective and quality of the functioning of the Development Operations Department. Qualifications Minimal acceptable level of education work experience and competency · BSBA degree or a relevant degree with strong emphasis on science. · Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience. · Must have working knowledge of ICH Good Clinical Practices and other relevant regulatoryhealth authority experience. · Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously. · Prior experience in assisting the conduct and management of multinational clinical trials is preferred. Disclaimer The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties responsibilities and qualifications. Management reserves the right to change or modify such duties as required. 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