Site Contracts Associate I

: Site Contract Associate I (Remote in Serbia)

The Site Contract Associate I (SCA) is responsible for negotiation with sites, finalization, and execution of all types of site contracts required for site activation. SCA is also responsible for ancillary documents associated with site contracts. Post site activation, SCA is responsible for negotiation, finalization, and execution of any amendments to the original contracts. The SCA ensures the highest standard of quality of final documents, as well as their compliance with relevant regulatory requirements, guidelines, and respective countrys applicable laws. The SCA ensures that contracts meet the needs of both clients and clinical trial sites, protecting the best interests of clients and the company (as applicable), while nurturing and maintaining positive relationships with clinical trial sites.

Parexel is looking for a Site Contract Associate based remotely in Serbia who is fluent in Italian. This is a great opportunity for someone with a legal or economics degree and/or work experience.

• 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 contracts 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. Provide functional guidance and keep internal and external teams aware of all contract statuses or pending issues. Prepare 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 the 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 needs 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-checking and reviewing contracts for completeness and accuracy.
• Ensure that changes are appropriately made, approved, and documented.
• Work within the forecasted country/site contracting timelines, ensure they are complied with, and track milestone progress in the agreed-upon contract tracking system in real time.
• Identify possible contract or process operational risk and proactively work with SCL to provide solutions.
• Review and comply with Standard Operating Procedures (SOPs) and any other relevant applicable guidance in a timely manner, keep training records updated accordingly and ensure 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.

• 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.

• Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint.
• Fluent in Italian.
• SCA I is an entry-level role and does not require specific industry experience.

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

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