Líder De Desarrollo Remoto En Bi Y Transformación

Randstad Argentina S.A.; Quilmes; À distance; ARS 600 000 - 960 000; Plein temps

Résumé du poste

Randstad Argentina S.A. is seeking a Contract Negotiator I in Clinical Research to join our country site activation team. This role is 100% remote with home-based work in Argentina, operating full-time with a Mon-Fri schedule.

You will manage country-level contract negotiations with clinical research sites, coordinate with the SAM and PM teams, ensure SOP compliance and timely document delivery, and provide local regulatory expertise.

Qualifications

• Health Sciences degree required.
• Over 2 years clinical research experience in contract negotiations with sites.
• Advanced command of English.
• Desirable experience in regulatory submissions & imports/exports post-authorization.
• Knowledge of GCP/ICH and regulatory guidelines.
• Excellent organization and prioritization skills.
• Excellent communication and interpersonal skills.

Responsabilités

• Perform country-level SA tasks per regs and SOPs and guidelines.
• Serve as SPOC for sites, SAM, PM team, and other departments.
• Ensure SOPs/WIs and deliverables meet timelines.
• Negotiate contracts with research sites.
• Lead startup and site activation activities and distribute docs.
• Maintain internal systems and tracking tools with project data.
• Track approvals and release of regulatory, ethics, ICF, IP documents.
• Provide local expertise to SAMs and project team during planning.
• Quality control documents provided by sites.
• May interact with sponsors on specific initiatives.

Connaissances

Advanced English

Organizational skills

Communication skills

Interpersonal skills

Teamwork

Problem solving

Attention to detail

Formation

Health Sciences degree

Bachelor's degree

High/Secondary school diploma or equivalent

Outils

eTMF

GoBalto

MS Office

Description du poste

Contract Negotiator 1, Clinical Research

100% Remoto Full-time

L–V 9:00 a 18:00

Buenos Aires, Argentina

Full time

R

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 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.
IQQIA 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.

EEO Minorities/Females/Protected Veterans/Disabled

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a FSP clinical Trial Coordinator - Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

• According to the specific role ( Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
• Provides system support (i.e. GoBalto & eTMF).
• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Reviews, completes and tracks local regulatory documents.
• Transmits documents to client and centralized IRB/IEC.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Maintains vendor trackers.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study‑specific translation materials and translation QC upon request.
• May attend Kick off meeting and take notes when required.

Education and Experience Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Bachelor's degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
• Excellent English language and grammar skills and proficient local language skills as needed
• Good presentation skills
• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete PPD clinical training program
• Self-motivated, positive attitude with effective strong interpersonal skills

Working Conditions and Environment

• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations