Senior Site Contracts Assistant

Key Accountabilities:

• 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
• Serves 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 
• Identifies 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
• Ensures that changes are appropriately made, approved and documented
• Works 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
• Identifies 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

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