Job Description

Please note: applicants must speak English and German. Polish and Hebrew are highly desirable but not mandatory.

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are looking for a SiteContract Leader whosemainresponsibility is thenegotiation of study specific, generic, site specific and country Clinical Site Agreements (CSA) and any other agreement that is required for thecompletion oftheSiteInitiation Visit(SIV)TheSiteContract Leader is also responsible for managingCSA activities and liaising with study specific stakeholders to ensure that the CSA start-up deliverablesaremet.

Key Accountabilities

Act as functional Leader on projects and develop study specific CSA strategy.

Drafting legal language and creating budgets for CSA negotiations.

Agree and negotiate study specific CSA templates with the Sponsor and Site as applicable.

Communicate CSA strategy, CSA turnaround timelines, tracking requirements and budget information/updates with key stakeholders. Coordinate interaction between Parexel study team and Sponsor as applicable to include but not limited to overall timeline management for CSA delivery.

Provide updates about template amendments, process changes, investigator fees, local requirements etc. to ensure that relevant CSA database is maintained in real time.

Early recognition of areas of potential problems and formulate contingency plans.

Define solutions strategy of significant CSA changes requested by the site.

Participate in client and team meetings.

Identify and facilitate CSA training needs as applicable.

Prioritize effectively and respond to urgent requests within team or sponsor lead.

Maintain a working knowledge of, and ensure compliance with, applicable ICH-GCP.

Guidelines, local regulatory requirements, and Parexel SOPs and study specific procedures

Key Accountabilities

Act as functional Leader on projects and develop study specific CSA strategy.

Drafting legal language and creating budgets for CSA negotiations.

Agree and negotiate study specific CSA templates with the Sponsor and Site as applicable.

Communicate CSA strategy, CSA turnaround timelines, tracking requirements and budget information/updates with key stakeholders. Coordinate interaction between Parexel study team and Sponsor as applicable to include but not limited to overall timeline management for CSA delivery.

Provide updates about template amendments, process changes, investigator fees, local requirements etc. to ensure that relevant CSA database is maintained in real time.

Early recognition of areas of potential problems and formulate contingency plans.

Define solutions strategy of significant CSA changes requested by the site.

Participate in client and team meetings.

Identify and facilitate CSA training needs as applicable.

Maintain and assure quality of work generated.

Prioritize effectively and respond to urgent requests within team or sponsor lead.

Maintain a working knowledge of, and ensure compliance with, applicable ICH-GCP.

Guidelines, local regulatory requirements, and Parexel SOPs and study specific procedures.

Qualifications

Skills

Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability.

Excellent interpersonal, verbal and written communication skills.

Ability to motivate both individuals and a team.

Ability to successfully work in a "virtual" team environment.

Must have strong analytical skills with the ability to create or interpret legal language and budgets.

Demonstrate thought leadership and innovation.

Maintain grace under pressure while displaying a high level of professionalism.

Align internal and external resources to achieve objectives.

Attention to detail.

Work effectively as part of a team.

Comprehend and interpret contract language.

Identify problems independently and execute solutions.

Quickly comprehend desired end-result, goal or objective and act to accomplish.

Demonstrated effective decision-making.

Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint.

Polished presentation skills.

Education

Degree in business, legal or life science or other relevant work experience in Contracting, Clinical Operations or in Legal (Paralegal).

Language Skills

FluentinwrittenandspokenEnglish and German(required)

Fluencyin Polish and Hebrew very desirable

Minimum Work Experience

1-3Years'experienceinsitecontractnegotiation

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.