Investigator Contracts Lead II - Spain - FSP

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 II 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.

Some details of the role:

- Contracting deliverables

• May act as single point of contact for studies with high priority or complex or unique contracting structures and strategies and is expected to be able to plan and solve for these situations with minimum oversight.
• Exercise independent judgement and decision making in areas of site contracting with moderate supervision.
• Effective management of contract and budget escalations from Functional Service Provider (FSP) / pCRO ICL with limited consultation.
• Make appropriate decisions, with limited oversight while balancing the risks for the client in making budget and contractual choices against the impacts to client clinical trial timelines
• Problem solving for site contracting issues of moderate complexity. This includes suggesting and implementing unique solutions, as needed, to achieve study goals.
• Follow client 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 other ICL, pCRO and FSP negotiators in achieving study goals with moderate support from site contracting team leads.
• Act as primary study point of contract 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.
• Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline.
  

- Collaboration

• 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.
  

Experience required for this role:

• At least 7 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.
  

Education:

• Bachelor’s Degree or equivalent and 7+ years of experience in clinical development operations or clinical trial outsourcing OR
• Master’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

For more information, please contact marta.kuniewicz@parexel.com