Site Monitor Lead

4 months ago

Centurion, South Africa IQVIA Full time

**Site Monitor Lead - Contingent Role**

**We are seeking professionals for an ADHOC/Contingent Opportunity - Details Below**

**About the Role**: The Site Monitor Lead is responsible for overseeing and coordinating the activities of site monitors to ensure the successful execution of clinical trials. This role involves ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. The Site Monitor Lead will act as a liaison between the clinical trial sites and the sponsor, providing guidance and support to site monitors and ensuring the integrity and quality of the data collected.

**Key Responsibilities**:

- ** Leadership and Supervision**:

- Lead and manage a team of site monitors, providing training, mentorship, and performance evaluations.
- Ensure that site monitors adhere to study protocols, regulatory requirements, and company SOPs.
- Coordinate and oversee site monitoring activities to ensure timely and accurate data collection.
- ** Site Management**:

- Develop and maintain strong relationships with clinical trial sites.
- Conduct site visits to ensure compliance with study protocols and regulatory requirements.
- Address and resolve any issues or concerns raised by site monitors or clinical trial sites.
- ** Quality Assurance**:

- Review and approve monitoring reports to ensure accuracy and completeness.
- Implement quality control measures to ensure data integrity and compliance with GCP.
- Conduct regular audits of site monitoring activities and provide feedback for improvement.
- ** Regulatory Compliance**:

- Ensure that all site monitoring activities comply with applicable regulatory requirements, including GCP and ICH guidelines.
- Stay updated on changes in regulatory requirements and industry best practices.
- ** Communication and Collaboration**:

- Serve as the primary point of contact between the sponsor and clinical trial sites.
- Facilitate effective communication and collaboration between site monitors, clinical trial sites, and other stakeholders.
- Provide regular updates to the Clinical Operations Manager on the status of site monitoring activities.

**Qualifications**:

- Bachelor’s degree in life sciences, nursing, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in clinical research, with at least 2 years in a supervisory or lead role.
- In-depth knowledge of GCP, and ICH guidelines.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Ability to travel as required.

**Skills**:

- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong analytical and problem-solving skills.
- Attention to detail and ability to work independently.
- Ability to manage multiple priorities and meet deadlines.

**#LI-DNP #LI-DNI #LI-CES

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