Site Activation Specialist

IQVIA Argentina; Petaling Jaya; Hybrid; MYR 60,000 - 90,000; Full time

Job summary

A leading global provider of clinical research services is seeking a Clinical Research Associate to act as a Single Point of Contact for assigned studies. The role involves regulatory activities, contract negotiations, and supporting project timelines. Candidates should have a Bachelor’s degree in life sciences and relevant experience in clinical research, along with strong negotiation and communication skills.

Qualifications

• 3 years’ clinical research or relevant experience.
• Deep knowledge of clinical systems and standards.
• Ability to work independently and prioritize tasks.

Responsibilities

• Serve as Single Point of Contact (SPOC) in assigned studies.
• Perform Regulatory, Start-up, and Maintenance activities.
• Review and negotiate site contracts and budgets.

Skills

Negotiation

Communication

Organizational Skills

Interpersonal Skills

Education

Bachelor’s Degree in life sciences or related field

Job description

Job Responsibilities:

1. Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership, and GICS. Ensure adherence to SOPs, WIs, quality of deliverables, and project timelines. Act as a Country Lead for projects without a regional Lead when applicable.

2. Perform Regulatory, Start-up, and Maintenance activities according to regulations, SOPs, and work instructions.

3. Prepare site regulatory documents, reviewing for completeness and accuracy.

4. Review, prepare, and negotiate site contracts and budgets with sites, if applicable.

5. Maintain accurate records in internal systems, databases, and tracking tools with project-specific information.

6. Ensure contracts are fully executed, regulatory documents and approvals are obtained, IP releases are authorized, and project deliverables are completed.

7. Review site performance metrics and provide feedback to management.

8. Establish and agree on project planning and timelines, ensuring overall project efficiency and adherence. Implement monitoring measures and contingency plans as needed.

9. Support collection, interpretation, analysis, and dissemination of regulatory intelligence for assigned studies and the wider company, as required.

10. Assist in pre-award activities such as bid defenses, proposals, and scope oversight at the country level.

11. Contribute to contract and budget template development.

12. Support importation activities.

13. Engage directly with sponsors on specific initiatives when necessary.

14. Act as Local Regulatory, Ethics, and Contract Expert, and review ICFs.

15. Mentor less experienced staff and deliver country-specific training.

16. Participate in feasibility and site identification activities.

17. Perform Site Selection Visits if trained as a monitor.

Job Requirements:

1. Bachelor’s Degree in life sciences or related field, with 3 years’ clinical research or relevant experience; or equivalent.

2. Deep knowledge of clinical systems, procedures, and standards.

3. Good negotiation and communication skills, with the ability to challenge when applicable.

4. Effective organizational and interpersonal skills.

5. Ability to work independently and prioritize tasks effectively.

6. Knowledge of GCP/ICH and applicable regulatory guidelines.

7. Understanding of regulatory requirements, including local regulations, SOPs, and corporate standards.

8. Familiarity with the regulated clinical trial environment and drug development process.

9. Ability to establish and maintain effective working relationships with colleagues, managers, and clients.

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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 medical treatments to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com