15 sep
|
TFS HealthScience
|
Buenos Aires
15 sep
TFS HealthScience
Buenos Aires
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 Provider (FSP)
solutions. The Clinical Research Manager (CRM) is responsible for
overseeing and monitoring clinical trial sites to ensure studies
are conducted in accordance with protocol, Good Clinical Practice
(GCP), ICH guidelines, and applicable regulatory requirements. The
CRM will support study sites throughout the clinical trial
lifecycle including initiation, monitoring, and close-out
activities. As part of our SRS team, you will be dedicated to one
sponsor, a general pharmaceutical or biotechnology company that is
an industry leader within its therapeutic area. Key
Responsibilities Conduct on-site and remote monitoring visits
including site initiation, routine monitoring, and close-out visits
Ensure clinical trials are conducted according to protocol, GCP,
ICH guidelines,
and applicable regulatory requirements Review
source documentation and Case Report Forms (CRFs) to ensure
accuracy, completeness, and data integrity Ensure the safety and
rights of study participants through proper informed consent
procedures and protocol compliance Verify proper management,
storage, and accountability of Investigational Products Prepare and
submit monitoring visit reports and follow up on identified issues
and action items with study sites Maintain study documentation
including Investigator Site Files and ensure timely submission to
eTMF Update CTMS and other project systems with accurate site-level
information Support audit and inspection readiness activities when
required Qualifications Bachelor's degree in Life Sciences,
Nursing, or a related field or equivalent experience Background in
Dermatology and/or Immunology is required At least 1 year of
clinical research experience
📌 Clinical Research Manager (Buenos Aires)
🏢 TFS HealthScience
📍 Buenos Aires