Strategic Site Contracts Lead for Clinical Trials

Jobtailor; Buenos Aires; On-site; ARS 1,000,000 - 1,600,000; Full time

Job summary

Jobtailor is seeking a contracts professional to administer contract management processes for clinical trials, negotiate budgets, and ensure compliance with regulatory standards.

This role collaborates with legal, finance and operations, leads site contracts, and mentors junior staff while maintaining timelines and quality across multiple projects.

Qualifications

• BA/BS degree in Business Administration, Public Administration, Public Health, or related field.
• Advanced degree preferred.
• Legal background (e.g. Law degree) is a plus.
• High level of contracts management experience.
• Experience in clinical research site contracts, including contract negotiations, budget development/review, and management of clinical agreements.
• Experience in a contract research organization or pharmaceutical industry essential.
• Strong knowledge of the clinical development process and legal and contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Good understanding clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation.
• Strong organizational skills with proven ability to handle multiple projects.

Responsibilities

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Provides support to SSUL to agree on country template contract and budget.
• Produces site-specific contracts from country template.
• Provides support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Works with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Supports in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Facilitates the execution of contracts by company signatories.
• Maintains contract templates and site specific files and databases.
• Trains and mentors less experienced staff members on departmental SOPs and ensures quality of team work products.
• Maintains and updates training material for site contract team.
• Acts as a communication liaison between site contracts staff and internal and external customers.
• Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.
• Prepares correspondence as necessary.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with SOPs and WIs in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

Skills

Contract management

Project management

Vendor management

Communication

Team orientation

Organization

Microsoft Office Suite

Education

BA/BS degree in Business Administration or related field

Advanced degree preferred

Law degree (plus)

Tools

Microsoft Office Suite

Job description

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Provides support to SSUL to agree on country template contract and budget.
• Produces site-specific contracts from country template.
• Provide support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Support in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Facilitates the execution of contracts by company signatories.
• Maintains contract templates and site specific files and databases.
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products.
• Maintains and updates training material for site contract team.
• Acts as a communication liaison between site contracts staff and internal and external customers.
• Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.
• Prepares correspondence as necessary.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
• Advanced degree preferred.
• Legal background (e.g. Law degree) is a plus.
• High level of contracts management experience.
• Experience in clinical research site contracts, including contract negotiations, budget development/review, and management of clinical agreements.
• Experience in a contract research organization or pharmaceutical industry essential.
• Strong knowledge of the clinical development process and legal and contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Good understanding clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation.
• Strong organizational skills with proven ability to handle multiple projects.

Core Competencies

Demonstrates expertise in contract management processes, including negotiation, budget development, and compliance with clinical trial regulations. Proficient in project management and vendor management within the clinical research environment.

Highest-signal resume keywords

• Contract Management Experience
• Clinical Research Site Contracts
• Budget Development/Review
• Project Management Experience
• Strong Knowledge of Clinical Development Process

ATS Optimization Keywords

Hard Skills

• Contract Negotiation
• Budget Management
• Clinical Trial Process Understanding
• Clinical Protocols Knowledge
• Quality Control
• Metadata Capture
• SOP Compliance
• Document Archival
• Contract Management Documentation
• Site-Specific Contracts Production

Soft Skills

• Excellent Communication Skills
• Interpersonal Skills
• Organizational Skills
• Team Orientation
• Presentation Skills

Industry Keywords

• Clinical Trials
• Pharmaceutical Industry
• Contract Research Organization
• ICH GCP
• Clinical Development

Tools & Technologies

• Microsoft Office Suite
• SSU Tracking System