07 sep
|
TFS HealthScience
|
Cataluña
07 sep
TFS HealthScience
Cataluña
About this role TFS 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 integral 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 le
📌 Medical Monitor (Cataluña)
🏢 TFS HealthScience
📍 Cataluña