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
