Clinical Trial Operations Manager

Há 7 dias

Brasília, Distrito Federal, Brasil ICON Plc Tempo inteiro
About the Role

We are seeking a highly skilled and experienced Clinical Trial Operations Manager to join our team at ICON Plc. As a key member of our operations team, you will be responsible for ensuring the successful delivery of clinical trials in the country.

Key Responsibilities
  • Oversee the overall study commitments within the country and ensure timely delivery of data to required quality.
  • Lead a Local Study Team consisting of Clinical Research Associates (CRAs) and Clinical Trial Associates (CTAs) for assigned studies.
  • Coordinate the site selection process by identifying potential sites and investigators, performing initial site quality risk assessments, and conducting site qualification visits to evaluate suitability and quality risks.
  • Ensure timely submission of applications and documents to Ethics Committees (ECs) and Institutional Review Boards (IRBs) at study start-up and throughout the study.
  • Collaborate with Regulatory Affairs to ensure timely delivery of applications and documents for submissions to regulatory authorities, in line with local regulations.
  • Verify that all country and site-level trial essential documents required by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP) are collected and verified for correctness prior to study start, in accordance with Standard Operating Procedures (SOPs).
  • Set up and maintain studies in Clinical Trial Management Systems (CTMS) at the country level and local websites, as required by local laws and regulations.
  • Oversee, manage, and coordinate monitoring activities from site activation through to study closure at the country and site level, in accordance with Monitoring Plans.
  • Review monitoring visit reports and proactively advise monitors on study-related matters.
  • Perform co-monitoring and accompanied site visits/training visits with study CRAs, as required.
  • Participate in training and coaching new members of the Local Study Team to ensure compliance with ICH-GCP.
Requirements
  • Bachelor's degree in a related discipline, preferably in life sciences, or equivalent qualification.
  • Solid experience in Development Operations (CRA, SrCRA) or other related fields.
  • Excellent verbal and written communication skills.
About ICON Plc

ICON Plc is a world-leading healthcare intelligence and clinical research organization. We advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. Our people are our greatest strength, and we are committed to providing an inclusive and accessible environment for all candidates.

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