Société : Kelly Services Lieu : Site source : Talent BE
Review and sign off on various operational plans related to Therapeutic Area (TA).Provide scientific input for responses to Health Authorities (HA) and Ethics Committees (EC).Act as a liaison between the company and clinical investigators, offering scientific guidance and addressing non-medical aspects.Work closely with various teams including Data Sciences, Data Management, Statistics, Programming, and others to ensure data integrity and support trial outcomes.Review data to ensure quality and identify trends.Lead Adjudication Activities and Data Visualization (DV) meetings, ensuring decisions are documented and communicated internally and externally.Manage contracting with clinical consultants, IDMC members, and KOLs, including payment oversight.Participate in vendor oversight focusing on data and technology integration in clinical trials.Contribute to completion of clinical study reports and preparation of oral and written results for health authority submissions.Partner with Regulatory Affairs to develop regulatory strategy and determine reporting requirements for health authorities.Assist in exploring and evaluating new assets or products to support compound value.Oversee setup of medical review tools and participate in Data Review Meetings.Assist in organizing content for IDMC presentations.Contribute to external communication and publication of scientific data.Assess medical publications emerging from the team and affiliates.Act as a company spokesperson regarding publication of clinical research findings.
Requirements and Qualifications PhD in relevant field (Neuroscience, Biomedical Sciences, Biology, Chemistry, Pharmacy), PharmD, or MD degree with 2-4 years of work experience; or Master's degree with 4-8 years of work experience.Experience supporting clinical studies, preferably in later stages (Phase II - III).Leadership experience with the ability to hit the ground running.Significant pharmaceutical industry experience.Energy and enthusiasm are essential.Experience in Neurology, Psychiatry, or Neuroscience is strongly preferred.Strong project planning, management, and communication skills.Ability to operate with limited day-to-day supervision.Independent decision-making and analytical skills.Successful work experience in a (virtual) matrix team environment.Willingness to travel up to 20% of the time, both domestically and internationally.
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Mah Rukh Chohdri T:
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