远程工作雷达

具有 CRO/制药经验的高级站点合同负责人(客户专属/远程)

Senior Site Contracts Lead with CRO/Pharma experience (Client Dedicated/Remote-U

职能支持限定地区(需当地身份)
公司Syneos Health India Private Limited
薪资$67,700 - $115,100/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间今天
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

高级站点合同负责人(具备CRO/制药行业经验,客户专属/远程-美国)
Syneos Health® 是一家领先的全集成生命科学服务组织,致力于加速客户成功。我们与药物研发和商业化全过程中的创新者合作,帮助他们应对复杂性、预见变化并加快进展。

我们的临床解决方案团队成员以药物研发的思维开展工作,运用多年的经验和专业知识,真正理解客户需求,并在我们打造的解决方案中代表这些需求。

无论您加入我们作为功能服务提供商合作伙伴还是全服务环境的一员,您都将与充满热情的问题解决者合作,作为团队共同创新,帮助我们的客户实现目标。我们敏捷且注重成果——为彼此、为客户,最重要的是,为有需要的人。

了解您的25,000名未来同事已经知道的内容:
为什么选择 Syneos Health

  • 我们致力于员工发展,通过职业发展和晋升;支持性的直线管理;技术和治疗领域培训;同行认可和全面奖励计划。
  • • 我们致力于构建一个包容的文化——在这里你可以真实地做自己。这背后的核心是我们“Driven to Deliver”(致力于交付)的使命,体现了我们同事每天展现的热情,塑造能够显著影响他人生活的解决方案。
  • • 我们不断打造我们所有人都希望工作的公司,也是客户希望合作的公司。为什么?因为我们知道,当我们将来自世界各地的聪明同事聚集在一起,我们可以塑造医疗健康的未来,为客户带来影响并定义患者进展的速度。

职位职责
为站点合同负责人团队和站点合同谈判人员建立、维护并更新培训材料。

作为组织内的专家,具备解决全球站点合同问题的能力,并作为公司内部客户的求助点,提供协助。

负责临床研究协议(CTA)的谈判,推动CTA文件的最终确定和执行,包括合同语言和条款、财务附件以及研究者资助预算,与全球站点合同和预算谈判团队协作。

监督合同与预算谈判

查看英文原文

Senior Site Contracts Lead with CRO/Pharma experience (Client Dedicated/Remote-US)Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
  • • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities
Establishes, maintains and updates training material for site contracts lead team and site contract negotiators.

Serves as subject matter expert within the organization equipped to help resolve global site contracting issues, and escalation point within the Company for internal customers to seek assistance.

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.

Advises study team and Sponsor stakeholders on industry trends, norms, and emergent developments surrounding site contract and budgetary negotiations. Provides consultation on potential risks and mitigation tactics for negotiation issues pertaining to overall study start-up needs.

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.

Identifies possible site contractual and investigator budgetary document or process operational risk and proactively works to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.

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.

Identifies best practices, investigates root causes of fundamental issues and problems for projects and recommends solutions.

Trains and mentors less experienced staff members on department Standard Operating Procedures (SOPs), processes, tools and templates and ensures quality of teamwork products.

May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.

May identify and lead internal team training and/or process improvement initiatives.

Participates in business development presentations as a subject matter expert in site contracts and investigator budget management within the Company

Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$67,700.00 - $115,100.00The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
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.

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.
Originally posted on Himalayas

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