Investigator Contracts Lead I - FSP

Reposted Yesterday
Be an Early Applicant
3 Locations
Remote
Senior level
Pharmaceutical
The Role
The Investigator Contracts Lead I negotiates site contracts and budgets for clinical trials, ensuring compliance and smooth operations while managing professional relationships with study sites.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is looking for multiple Investigator Contracts Lead I (ICL I) positions in Brazil, Argentina and Mexico.
The investigator Contracts Lead I is 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.

Key Accountabilities:

Contracting deliverables

  • Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines
  • 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 study level site contracting activities, direct other ICL and 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, CRO site contracting teams
  • Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives

Compliance with Parexel standards

  • Complies with required training curriculum
  • Completes timesheets accurately as required
  • Submits expense reports as required
  • Updates CV as required
  • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

  • 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

Knowledge and Experience:

  • Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
  • Knowledge of the principles, concepts and theories in applicable business discipline
  • Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred

Education:

  • Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing

Skills Required

  • 5+ years of experience in clinical development operations or clinical trial outsourcing
  • Bachelor's Degree or equivalent
  • Experience with clinical study budgets and contracting negotiation principles
  • Fluency in written and spoken English
  • Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

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The Company
HQ: Durham, North Carolina
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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