Clinical Trial Manager

Há 6 dias

São Paulo, São Paulo, Brasil IQVIA Tempo inteiro
Job Title: Clinical Trial Manager

About the Role:

We are seeking a highly skilled Clinical Trial Manager to join our team at IQVIA. As a Clinical Trial Manager, you will be responsible for the local management of clinical trials in a country or countries, ensuring compliance with Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), and local regulatory requirements.

Key Responsibilities:

  1. Develop and implement local trial management strategies to ensure successful trial execution.
  2. Collaborate with cross-functional teams to prepare high-level budget estimates and detailed budget proposals.
  3. Act as primary company contact for assigned trials, ensuring local/country teams track project progress against planned timelines and monitor patient recruitment rates.
  4. Drive study compliance by maintaining and updating trial management systems, using study tools and management reports to analyze trial progress.
  5. Participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
  6. Escalate corrective and preventive actions (CAPA) to GTL MAO and CPL when trials deviate from plans.

Requirements:

  1. BA/BS degree in a health or science-related field.
  2. Minimum of 1 year of local trial management experience in the pharmaceutical industry or CRO, with previous experience as a Clinical Research Associate.
  3. Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
  4. Strong IT skills in appropriate software and company systems.
  5. Excellent decision-making and strong financial management skills.
  6. Proficient in speaking and writing the country language and English.

About IQVIA:

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

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