Principal Site Contract Lead. (Poland) Sponsor dedicated.

3015 Syneos Health Poland sp. z o.o.; Polska; Hybrid; PLN 350,000 - 520,000; Full time

Job summary

Syneos Health Poland sp. z o.o. seeks a Principal Site Contract Lead to oversee development and negotiation of R&D site contracts, investigator-initiated and related agreements.

You will help protect sponsor interests, ensure regulatory compliance, and drive timely execution across multiple studies. The role requires advising study teams on country-specific contracting nuances, coordinating with CROs or sites, and delivering value through strong negotiation and risk management skills in a

Qualifications

• Experience in drafting and negotiating site contracts, including sponsor and investigator-initiated agreements.
• Ability to assess FMV and ensure compliance with regulations.

Responsibilities

• Develop and negotiate R&D site contracts and related agreements.
• Advise study teams on country-specific site contracting considerations.
• Lead contract management for multiple studies and coordinate with CROs or sites.
• Escalate risks to sponsor colleagues and propose mitigations.
• Ensure contracts reflect Fair Market Value and regulatory compliance.

Skills

Contract management

Negotiation

Cross-functional leadership

Regulatory knowledge

Job description

Principal Site Contract Lead. (Poland) Sponsor dedicated.

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 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.

Job Responsibilities

Perform and manage all activities associated with developing and negotiating R&D site contracts, including company sponsored and investigator sponsored clinical site contracts, nonclinical contracts, confidentiality disclosure agreements, and cooperative research agreements. Responsible for timely delivery of R&D site agreements that protect the sponsor business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”).

• Advise study teams on the country specific characteristics related to site contracts, for the client sponsored study of any complexity, including contribution to site selection process and site prioritization activities;
• Supporting as Lead Contract Manager, one point of contact for multiple studies
• Prepare, distribute, negotiate, and drive to execution site contracts Clinical Trial/Study Agreements or Study Letter if Master Agreement is in place) with the appointed Clinical Research Organization (“CRO”) or affiliate or directly with the site as appropriate
• Escalate to appropriate sponsor colleague when a significant risk to the business is identified
• Independently make appropriate business decisions within their scope of authority and educate internal project leaders on the issues and risks associated with contracting and/or budget decisions.
• Ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs.
• Identify potential risks and manage issue resolution of high complexity.
• Ensures status reports are provided to appropriate parties both internally and externally on a regular basis.
• Evaluate changes, identify business and/or legal risk associated with such changes and escape relevant requests to either legal and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback to facilitate the review.
• Evaluate changes requested within contracts, identify business and/or legal risk associated with such changes and escalated relevant requests to either legal team leads and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback, whenever possible, to facilitate the review.
• Participate in the drafting and/or revision of the contract templates, when necessary, escalating to legal team leads.
• Escalate issues when needed and encourage resolution at the lowest appropriate level.
• Drive department specific initiatives and projects regionally or globally
• Create back-up and or mitigation plans in order to get in front of potential specific risks within the department
• Requires minimal supervision
• Capitalize on strengths of relationships/networks to effectively work with cross functional teams and influence these teams as necessary

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Learn more about Syneos Health. http://www.syneoshealth.com

Additional Information

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. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.