Contract Negotiator 1, Clinical Research

IQVIA Inc; Tandil; Remote; ARS 600,000 - 900,000; Full time

Job summary

IQVIA is seeking a Contract Specialist to join our Country Site Activation team in Argentina, fully home-based. This role serves as the SPOC for investigative sites and collaborates with the SAM and project teams to drive contract negotiations and site activation.

Requirements include a Health Sciences degree, 2+ years of clinical research experience, and advanced English. Knowledge of GCP/ICH and regulatory guidelines is essential for ensuring timelines and deliverables are met.

Qualifications

• 2+ years clinical research experience in contract negotiations with clinical research sites.
• Health Sciences degree.
• Advanced command of English.
• Desirable experience in regulatory submissions & imports/exports that correspond to activities subsequent to the authorization of a clinical protocol in the country.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Excellent organization and prioritization skills
• Excellent communication and interpersonal skills.

Responsibilities

• Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to SOPs, WIs, quality of designated deliverables and project timelines.
• Contract negotiations with research sites.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Skills

Clinical research experience

Advanced English

Education

Health Sciences degree

Job description

We are looking for a Contract Specialist to join our Country Site Activation team!

Location: Argentina - full Home based

What You´ll Do

• Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Contract negotiations with research sites.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

What Will Help You Succeed

• +2 years clinical research experience in contract negotiations with clinical research sites
• Health Sciences degree
• Advanced command of English language.
• Desirable experience in regulatory submissions & imports/exports that correspond to activities subsequent to the authorization of a clinical protocol in the country.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Excellent organization and prioritization skills
• Excellent communication and interpersonal skills

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. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.