Offer summary

Qualifications:

Bachelor’s Degree or equivalent with 5+ years of experience in clinical development operations or clinical trial outsourcing., Juris Doctorate or equivalent with 2+ years of experience in clinical development operations or clinical trial outsourcing., Experience in negotiating contracts and budgets with clinical sites is essential., Fluency in written and spoken English is required. .

Key responsabilities:

Lead direct site-facing contract and budget negotiations with clinical investigator sites.

Oversee the global site budget process and manage escalations in site budgeting and contracting.

Collaborate with various teams to ensure alignment with contracting and compensation requirements.

Contribute to the design and implementation of major business initiatives or special projects.

Job description

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 currently seeking to hire an experienced site contracts lead, someone who has experience negotiating both contracts and budgets with clinical sites.

In this key role 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.

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
Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing

Required profile