Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Clinical Trial Planning Contract Management Contract Management Project Implementation Contract Management Escalation Management Performance Based Contracting Price Negotiation Contract Management Budget Management +6 more

Other Skills

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Decision Making
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Collaboration
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Planning
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Communication
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Leadership
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Detail Oriented
•
Presentations

Roles & Responsibilities

Bachelor’s Degree or equivalent with 5+ years of experience in clinical development operations or clinical trial outsourcing, OR Juris Doctorate or equivalent with 2+ years of experience in clinical development operations or clinical trial outsourcing.
Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities, including drafting and negotiation of Clinical Trial Agreements with global sites.
Knowledge of ICH-GCPs, Parexel processes, and applicable regulatory requirements; strong compliance and quality focus.
Excellent written and spoken English communication skills; ability to operate effectively in a highly matrixed organization and influence without direct authority.

Requirements:

Lead study-level site contracting activities, negotiate terms with investigators/institutions, and manage timelines and budget impacts in collaboration with Legal and other stakeholders.
Develop and oversee the global site budget process; work with partners to develop, track, and execute site budgets and contracts for sponsored clinical trials.
Collaborate with Legal, Finance, pCRO and other divisions to manage escalations, identify areas for improvement, and serve as primary contract contact for assigned studies.
Ensure compliance with Parexel standards and regulatory requirements; complete required training, submit timesheets and expense reports, and maintain an up-to-date CV.

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.

REMOTE POSITION- US

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

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