Detalles de la oferta

.**Work Schedule**Other**Environmental Conditions**OfficeAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.**Location/Division Specific Information**:Performs and coordinates different aspects of the clinical monitoring and site management process.**Discover Impactful Work**:Conducts remote or on**A day in the Life**:- Monitors investigator sites with ability to manage complex studies and/or challenging sites using a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.- Assess investigational product through physical inventory and records review. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.- Provides updates on potential trends noted across multiple sites and discusses strategies for their management to the Clinical Team Manager (CTM).- Ensures study systems are updated per agreed study conventions (e.G. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.- Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.- Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.**Keys to Success**:**Education**:Bachelor's degree in a life science related field or equivalent and relevant formal academic / vocational qualification


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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