Site Contract Leader

Parexel; Petaling Jaya; Sur place; MYR 70 000 - 105 000; Plein temps

Résumé du poste

Parexel Malaysia seeks an experienced Site Contracts Associate to draft, review and negotiate clinical site agreements and related documents, ensuring compliance with ICH-GCP and local laws. You will coordinate with sites and internal teams to keep contract statuses current and drive timely approvals.

The ideal candidate has a bachelor’s degree in a related field, 2–5 years in CRO/site contracting, and strong negotiation, communication, and MS Office skills.

Qualifications

• Bachelor degree required in a related field.
• Experience in CRO/site contracting preferred.
• Fluent in English; strong legal language interpretation skills.

Responsabilités

• Draft, review and negotiate all site agreements including clinical study and service agreements.
• Provide context to comments from sites considering local legal frameworks.
• Apply site contracts against negotiation and budget parameters.
• Ensure documents comply with laws and ICH-GCP.
• Serve as liaison between site contracts staff and customers; track contract statuses.
• Manage contract execution, signatures, and timely completion.
• Maintain records and archives and ensure process improvements.

Connaissances

Negotiation

Communication

Analytical skills

Attention to detail

Legal language interpretation

Cross-functional collaboration

Formation

Bachelor's degree in related field

Outils

Excel

Word

PowerPoint

Description du poste

• 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

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
• 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

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