CDA Manager

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

The Site Contract Associate II (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 to 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 needs of both clients and clinical trial sites protecting best interests of clients and the company (as applicable) while nurturing and maintaining positive relationships with clinical trial sites.

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 andbusiness 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

Knowledge and Experience:

• Solid working proficiency of all MS Office Products specifically Excel Word and PowerPoint
• SCA II requires 2-5 years of experience in site contracting or combination with a related field within the CRO industry

Education:

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