Contract Negotiator 1, Clinical Research

ARG IQVIA RDS Argentina SRL; Buenos Aires; Remote; ARS 900,000 - 1,300,000; Full time

Job summary

IQVIA Inc in Argentina is seeking a Contract Specialist to join the Country Site Activation team on a full home based basis. You will manage country level site activation tasks, negotiate contracts with investigative sites, and ensure SOPs, WIs, and timelines are followed while coordinating with SAM and project teams.

The role requires at least 2 years of clinical research experience in site contract negotiations, a Health Sciences degree, and advanced English.

Qualifications

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

Responsibilities

• Perform country-level Site Activation (SA) tasks in accordance with SOPs, WIs, project requirements and budget guidelines.
• Serve as Point of Contact (SPOC) for sites, SAM, PM team, and other departments.
• Negotiate contracts with research sites and manage start-up activities.
• Distribute documents to sites and project team members.
• Maintain internal systems and tracking tools with project information.
• Review, track and follow up on document approvals, regulatory, ethics, ICF, IP releases.
• Provide local expertise during project planning.
• Perform quality control of documents from sites.
• Direct contact with sponsors on initiatives when needed.

Skills

Contract negotiations

Clinical research

English proficiency

GCP/ICH guidelines

Regulatory knowledge

Communication skills

Organizational skills

Interpersonal skills

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

• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
• 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.