This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
At Parexel FSP, people make a difference. We have a key mission: to prevent and treat disease by bringing important new medicines and therapies to patients in need. We achieve this important goal through the expertise, experience, innovation, and commitment of our employees around the world. Our employees have the opportunity to do meaningful things around the world, while we support them locally in environments of challenge, collaboration, flexibility and industry-leading growth potential. Parexel FSP is looking for an Investigator Contracts Lead in Spain, 100% remote. In this position, you will be responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also includes managing the Per-Subject Cost (PSC) process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO) and collaborating with other lines to plan site contracting timelines though start up. Expect exciting professional challenges, but with a healthy work-life balance. Your wellbeing is as important to us as our patients. For each role, we look for professionals who have the determination and courage to always put the patient's wellbeing first. For us, this is a job with heart.
Job Responsibility:
Direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments
Oversight of other contracting professionals on assigned studies
Managing the Per-Subject Cost (PSC) process for assigned studies
Managing escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO)
Collaborating with other lines to plan site contracting timelines though start up
Exercise good judgment in balancing the risks to the sponsor in making budget and contractual decisions against the impacts to client clinical trial timelines
Follow processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials
Work with partners to develop and oversee the global site budget process
Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters
Lead study level site contracting activities and act as primary study point of contact for site contracting issues and timelines on assigned studies
Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space
Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space
Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements
Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, and CRO site contracting teams
Contributes to design, development and implementation of major business initiatives or special projects where required.
Requirements:
At least 3 years of experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation is preferred
Balance of general business, compliance, finance, legal, and drug development experience
Precise communications and presentation skills
Ability to plan, identify and mitigate risks to site contacting timelines
Ability to lead by influence rather than positional power to accomplish critical deliverables
Success in working in a highly matrix-based organization
Fluency in written and spoken English is required
Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing.