Key Facts

Remote From:

Fixed term

Mid-level (2-5 years)

English, Dutch

Hard Skills

Contract Management Contract Management Contract Management Drug Development Clinical Data Management Contract Management Specimen Handling Finance Clinical Study Design Auditing +4 more

Other Skills

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Non-Verbal Communication
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Social Skills
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Detail Oriented

Roles & Responsibilities

Bachelor’s degree in life science, law, finance, or an equivalent qualification
At least 2 years of site contract negotiation/customization experience
Excellent knowledge of ICH-GCP guidelines; basic knowledge of GMP/GDP
Fluent in English and Dutch with strong written and verbal communication and negotiation skills

Requirements:

Adapt global templates of agreements to local use in accordance with local requirements and SOPs; develop and negotiate clinical site budgets based on Fair Market Value
Negotiate agreement language and budget with clinical study sites and maintain the status of agreements, budgets, issues, payments, amendments, and communications for the duration of the study
Act as point of contact with Legal to ensure contract integrity and ensure all contracts are executed in a timely manner for efficient site start-up
Support internal and external audits and ensure compliance with client Codes of Conduct and company policies; ensure all contracts are included in the Trial Master File (TMF)

Parexel

Pharmaceuticals

About Parexel

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.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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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.

Key Accountabilities:

Adapts global templates of agreements to local use in accordance with local requirements and SOPs.
Develops and negotiate clinical site budgets based on Fair Market Value.
Negotiates agreement language and budget with clinical study sites.
Acts as point of contact and interface with Legal if necessary to ensure integrity of contracts.
For each agreement maintains the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources. Ensures final contract documents are consistent with agreements reached at negotiations.
Ensures all agreements are executed in a timely manner contributing to efficient site start-up timelines.
Supports internal and external audits activities.
Ensures compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology, and security.
Ensures that all contracts are included in the Trial Master File (TMF).

Skills:

Excellent attention to details.
Good written and verbal communication skills.
Good collaboration and interpersonal skills.
Good negotiation skills.
Fluent in English and Dutch

Knowledge and Experience:

At lease 2-year experience in site contract negotiation/customization.
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
Good knowledge of relevant local regulations.
Basic understanding of the drug development process.
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Education:

Bachelor’s degree in related discipline, preferably in life science, law, finance, or equivalent qualification.