When our values align, there's no limit to what we can achieve. 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• 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
Free
Site Contract Associate I/ii, Taiwan
Taiwan, 台北, 台北市,
發表 November 26, 2024
描述
聯繫雇主
雇主信息
PAREXEL International is a leading global biopharmaceutical services provider, which continues to be a premier, trusted partner to clients who rely on the Company for expertise and flexibility, as well as the efficiencies of a worldwide infrastructure, to help them more quickly achieve their development and commercialization goals. For 30 years, PAREXEL has complemented client organizations with strategic insight, deep scientific knowledge, tactical expertise, and a wealth of experience throughout the development process. The Company's offerings include worldwide regulatory expertise, Phase I-IV clinical research services, eClinical technologies that accelerate development, and integrated commercialization services. PAREXEL is focused on providing tailored solutions that match a client's specific needs by applying the right blend of resources and capabilities, as well as the right guidance and high level of quality needed to help them bring safe and effective treatments to patients sooner.
Headquartered near Boston, Massachusetts, PAREXEL operates in over 70 locations throughout more than 50 countries, and has over 11,000 employees worldwide.
Visit www.PAREXEL.com for more information.
Specialties
Regulatory and product development consulting,
early phase clinical research,
phase II-III clinical research,
late phase clinical research,
eClinical solutions,
patient and site recruitment,
clinical logistics,
flexible outsourcing models,
strategic partnering