25 may
|
Syneos Health
|
Buenos Aires
25 may
Syneos Health
Buenos Aires
Postúlate en Kit Empleo: kitempleo.com.ar/empleo/q1e55
Site Contracts Specialist with CRO/Pharma experience home-based in Argentina
Description
Site Contracts Specialist with CRO/Pharma experience home-based in Argentina.
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
Job Responsibilities
Lead multi-country projects including negotiating and preparing contracts, budgets and related documents for industry-sponsored clinical trials.
Produce site-specific contracts from country CTA template and review/own site-specific contracts, submitting proposed CTA and investigator budget for site review.
Negotiate budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
Perform quality control and arrange execution of CTAs, archival of documents into repositories and capture of metadata.
Review contracts for completeness and accuracy, ensuring corrections are appropriately made and documented.
Administer all contract management processes, coordinating with protocol, informed consent, institution, investigator, vendor, consultant and customer agreement documents at a project level.
Generate amended contract and/or budget documents as necessary, preparing contract management documentation for projects and streamlining contract/proposal or internal processes.
Work closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
Validate department budget load and backlog with SSU lead, Clinical Operations and Finance.
Identify possible contract or process operational risk and proactively work within the team to provide solutions.
Escalate deviations to department leadership, Site Contract Service Center and/or Legal Department.
Provide support to business development and represent site contracts/Site Start-Up (SSU) in internal or customer meetings.
Ensure forecasting country/site contracting timelines are complied with and track milestone progress in the SSU tracking system in real time.
Collaborate with legal, finance and clinical operations departments, communicating and explaining legal and budgetary issues.
Maintain and support review and development of contract templates, budget templates and site-specific files and databases.
Serve as key communication liaison between site contract staff and internal and external customers, providing functional guidance and keeping teams aware of all contract statuses or pending issues.
Train and mentor less experienced staff on SOPs, ensuring quality of team work products and updating training material.
Participate in higher-level discussions about company goals, departmental objectives and specific project aims.
Facilitate execution of contracts by company signatories.
Monitor basic financial aspects of the project and hours/tasks per contract, escalating discrepancies in a timely fashion.
Review and comply with SOPs and WIs, keeping training records updated and ensuring timesheet compliance.
Qualifications
BA/BS in Business Administration, Public Administration, Public Health or related field; advanced degree preferred.
Moderate contract management experience in a CRO or pharmaceutical industry.
Management experience preferred.
Strong knowledge of the clinical development process and legal and contracting parameters.
Strong computer skills in Microsoft Office Suite.
Customer focused with ability to manage challenging priorities and remain versátil in stressful situations.
Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
Good understanding of clinical protocols and associated study specifications.
Excellent understanding of clinical trial start-up processes.
Project management experience in a fast-paced environment.
Vendor management skills and strong organizational skills with proven ability to handle multiple projects.
Excellent communication, presentation and interpersonal skills.
Quality driven in all managed activities.
Strong negotiating and problem-solving skills.
Ability to mentor and motivate more junior staff.
Provide quality feedback and guidance to peers.
Contribute to a training and quality assurance plan within SSU and update SOPs/WIs.
Additional Information
Tasks, duties and responsibilities as listed in this job description are not exhaustive.
The Company, at its sole discretion and with no prior notice, may assign other tasks, duties and job responsibilities.
Equivalent experience, skills and/or education may also be considered.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Nothing contained herein should be construed to create an employment contract.
All employment is subject to the laws of the jurisdiction in which the employee works and any work performed.
Applicants are encouraged to provide details of experience related to the essential responsibilities of the role.
Application materials are confidential and protected under applicable law.
We are committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within the Site Start-Up/Site ID job family manage and execute the site identification process in accordance with regulations, SOPs and project requirements.
This includes completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs), maintaining and reporting site performance metrics, serving as the primary point of contact for investigative sites, and tracking completion of site identification.
Individual contributors may manage up to two employees, direct work of lower-level professionals, and focus on the design, implementation or delivery of processes, programs and policies.
Responsibilities require practical knowledge typically acquired through education and experience.
Get to know Syneos Health
Over the past 5 years we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo in a highly competitive and ever-changing environment.
Learn more about Syneos Health at
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Postúlate en Kit Empleo: kitempleo.com.ar/empleo/q1e55
📌 Site Contracts Specialist With Cro/Pharma Experience Home-Based In Argentina (Buenos Aires)
🏢 Syneos Health
📍 Buenos Aires