Descripción de la oferta
About this roleTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.The Medical Monitor ensures participant safety, oversees clinical trial protocols, and maintains data integrity throughout the research process.As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.Key Responsibilities- Provide medical consultation on study-related matters, including participant eligibility, protocol-related questions, efficacy and safety procedures, concomitant medication, adverse events, and SAE reporting.- Review SAE narratives and support the early identification of safety concerns across clinical studies.- Review and classify protocol deviations and assess exclusionary or alert laboratory values, as well as other relevant testing data.- Support the medical review of participant data listings, patient profiles, and medically coded terms to ensure consistency and medical appropriateness.- Provide guidance on investigational product administration issues when needed.- Lead medical discussions and teleconferences with internal study teams and external clinical service providers, including CROs.- Deliver therapeutic area and/or protocol training to relevant study team members.- Contribute to IRB/Ethics Committee and regulatory authority submissions when required.- Review and, when needed, co-author key study documents such as protocols, Medical Monitoring Plans, Safety Management Plans, Informed Consent Forms, and Clinical Study Reports.- Support patient enrollment activities when appropriate.Qualifications- Medical Degree with Registration Certificate.- At least 3 years of experience in Clinical Research.- GCP training.- Advanced level of English.- Experience reviewing clinical and safety data within clinical trials. This is consistent with the operational and medical-review focus described in the intake.- Strong medical judgment and the ability to interpret clinical data in a development context.- Good interpersonal skills and the ability to build effective relationships with both internal and external stakeholders.- Strong communication and presentation skills, with the ability to communicate clearly and concisely in writing.- Strategic thinking, attention to detail, and the ability to work effectively in cross-functional teams.What We OfferWe provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.#J-18808-Ljbffr
