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Dutch speaking Clinical Site Contracts Lead - Sponsor Dedicated

Employer
Syneos Health
Location
Netherlands
Salary
Competitive
Start date
10 Jan 2023
Closing date
7 Feb 2023

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description

Site Contracts Specialist / Lead - Netherlands - Hybrid home and office working in Utrecht (2-3 days office based per week)

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

For our client, an global top tier pharmaceutical company, we are currently looking for a Site Contract specialist or lead. You'll work from their office in Utrecht 2 -3 days per week, the other days you can work from home.

In this role yo u'll Responsible for the management of budgeting and contracting for Study Teams with a focus on contracting a variety of contracts & study types including Confidential Disclosure Agreements (CDAs), Investigator contracts for the client's sponsored studies, non-registrational / Investigator Sponsored Research (ISR) studies.

Job responsibilities
• Oversees negotiations of clinical study agreements (CTA´s) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators.
• Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers in all regions of study conduct. Provides consultation during escalation of out-of-parameter queries as needed.
• Acts as first-line subject matter expert for all such CTA elements on assigned studies for internal and sponsor stakeholders alike. Advises stakeholders on issue resolution within the context of assigned studies. May seek additional support from internal support structures as needed.
• Plans contract execution strategy for assigned studies-including forecast of site-specific contractual execution timelines with as much accuracy as possible and coordinates with internal study team stakeholders to ensure that CTA strategy is aligned with overall study start-up plans and expectations overall. Manages expectations of internal and sponsor study team regarding global CTA negotiations for assigned studies.
• Coordinates communications between study team stakeholders and global team of site-facing site contract & budget negotiators including roll-up of all status updates to regular team forum. Participates in regular study calls to facilitate communication as needed.
• Works closely with internal stakeholders and with Sponsor to prepare site contractual templates, including payment terms, and study-level negotiation parameters and processes within Company standards in order to drive successful negotiation of contracts and budgets.
• Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program.
• Creates and maintains document status reports, and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.
• Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Manages site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
• May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

What we’re looking for
• BS degree in life sciences, a health related field, or equivalent combination of education and experience.
• Ability to be partially office based in Utecht
• Preferred experience in a CRO/pharmaceutical industry and related clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience.
• Thorough knowledge of applicable regulations, drug development and clinical project management procedures.
• Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), MS Project, outlook and Internet.
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
• Attention to attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines. Strong leadership skills; ability to teach/mentor team members.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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