Senior/Principal Site Contracts Associate

Posted Yesterday
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Shanghai, Shanghai Municipality, Shanghai, CHN
In-Office
Senior level
Pharmaceutical
The Role
Lead drafting, review, negotiation and execution of clinical site agreements ensuring compliance with laws, regulations and ICH-GCP. Manage contract lifecycle, track statuses, resolve issues, align terms with protocol/budget, mentor junior staff, and implement process improvements to meet study timelines and quality standards.
Summary Generated by Built In

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.

Key Accountabilities:

SCA Tasks

  • Draft, review and negotiate all site agreements including but not limited to clinical study agreements, service agreements, team member agreements and other types of related documents like letters, notices, etc.
  • Provide context to comments received from sites in light of local legal and business framework, common practices, and past negotiation experience for the purpose of further review up the decisioning chain
  • Apply and scrutinize site contract and related documents and their revisions against negotiation and budget parameters (as applicable)
  • Ensure final documents comply with applicable laws, regulations, and guidelines, including ICH – GCP
  • Ensure the best interest of both clients and Parexel are met
  • Serve as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
  • Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties
  • Follow record maintenance and archival guidelines to ensure they are met
  • Develop and maintain positive relationships with clinical trial sites
  • Develop and maintain a thorough understanding of the clinical trial protocol, budget, and timelines to ensure that contract terms align with the overall trial goals and objectives
  • Identify potential issues or concerns with contract terms and collaborate with internal stakeholders and clinical trial sites to find mutually acceptable solutions
  • Stay up to date with relevant regulatory requirements, guidelines and applicable laws in respective country
  • Identify if all necessary documents, such as Power of Attorney, Insurance Certificates, Indemnification Letters, Informed Consent Form, referenced agreements or any other correlated documents are in line and in place for the need of Clinical Site Agreement
  • Track and report on the statuses of site contracting activities to Site Contract Lead, other internal stakeholders and study teams
  • SCA is responsible for first time quality by self-check and reviews contracts for completeness and accuracy
  • Ensure that changes are appropriately made, approved and documented
  • Work within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon contract tracking system in real time
  • Identify possible contract or process operational risk and proactively works with SCL to provide solutions
  • Reviews and complies with Standard Operating Procedures (SOPs) any other relevant applicable guidance in a timely manner, keeps training records updated accordingly and ensures timesheet compliance
  • Ensure adequacy and accuracy of archived records
  • Identify and implement process improvements to increase efficiency and quality in the site contracting process
  • Provide guidance and support to study teams and project management on site contracting matters in the respective country
  • Participate in cross-functional communication to identify process improvements and contribute to the development of site contracting strategies
  • Must be highly proficient in all the above accountabilities
  • Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensure quality of team’s work products. Maintain and update training material for site contract team
  • Be familiar with financial implications of the project and the number of hours/tasks available per contract and hours consumed; escalates discrepancies in a timely fashion
  • Act as country expert by keeping up to date with country trends in site contracting and utilizing knowledge to inform and guide Site Contract Lead, other internal stakeholders, and study teams

Skills:

  • Possess strong negotiation, diplomacy, and excellent organizational skills with demonstrated experience handling multiple projects
  • Excellent interpersonal, verbal and written communication skills
  • Strong problem-solving skills
  • 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
  • Maintain grace under pressure while displaying a high level of professionalism
  • Align internal and external resources to achieve objectives
  • Attention to detail
  • Comprehend and interpret contract language
  • Identify problems independently and execute solutions
  • Quickly comprehend desired end-result, goal or objective and act to accomplish
  • Polished presentation skills
  • Quality-driven in all managed activities
  • Fluent in written and spoken English, command of additional languages is beneficial
  • Ability to mentor and motivate more junior staff
  • Demonstrate an ability to provide quality feedback and guidance to peers

Knowledge and Experience:

  • Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint
  • Principal SCA requires 8+ years of experience in site contracting or combination with a related field within the CRO industry

Education:

  • Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience

Skills Required

  • 8+ years experience in site contracting or related CRO field
  • Bachelor's degree in law, economics, business, social sciences or equivalent experience
  • Draft, review and negotiate clinical study/site agreements and related documents
  • Ensure compliance with applicable laws, regulations and ICH-GCP
  • Manage contract execution process including obtaining required signatures
  • Solid proficiency with MS Office (Excel, Word, PowerPoint)
  • Strong negotiation, interpersonal, verbal and written communication skills
  • Ability to interpret legal language, budgets and financial implications of projects
  • Experience maintaining contract records, tracking statuses and using contract tracking systems
  • Experience training, mentoring and providing guidance to junior staff
  • Fluent written and spoken English
  • Command of additional languages

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

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.

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