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Clinical Lead

2 weeks ago

Bloemfontein, Orange Free State, South Africa IQVIA Full time
Job Overview

The Clinical Lead will provide strategic leadership of the centralized monitoring team, working in collaboration with project and clinical leads to achieve the delivery of project objectives. This includes optimizing speed, quality, and cost of delivery, while adhering to standard operating procedures, policies, and practices.

Main Responsibilities

  • Lead the centralized monitoring team to ensure successful implementation of strategies to address clinical risks and issues.

  • Facilitate efficient review of Site Visit Reports and maintain consistent standards of implementation for quality, meeting or exceeding quality standards.

  • Ensure subject safety, data integrity, escalation of issues, and timely feedback in compliance with IQVIA standard operating procedures, ICH GCP guidelines, protocol requirements, and regulatory compliance.

  • Provide expertise support in centralized monitoring studies from an Applications, Analytics, and Therapeutics or Quality perspective.

Qualifications and Experience

  • Bachelor's Degree in clinical or life sciences, or a related field, or medical degree.

  • Minimum 5 years of relevant experience or Medical degree with a minimum 4 years of clinical trial experience.

  • Advanced knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements, such as ICH GCP and relevant local laws, regulations, and guidelines, towards clinical trial conduct.

  • Good Clinical system expertise.

  • Strong written and verbal communication skills, including good command of the English language.

  • Results-driven approach to work delivery and output.

  • Understanding of clinical/medical data.

  • Good motivational, influencing, negotiating, and coaching skills.

  • Ability to work on multiple projects and manage competing priorities.

  • In-depth therapeutic and protocol knowledge.

  • Strong organizational, problem-solving, and decision-making skills.

  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics.

  • Effective presentation skills.

  • Ability to work across cultures and geographies, with high awareness and understanding of cultural differences, and maintain effective working relationships with coworkers, managers, and clients.