Site Contract Associate II - German speaker

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.Parexel are looking for a Site Contract Associate I to join our Site Contracts team. This role can be based remotely in either Serbia or Romania.In this position you will support the DACH region therefore a fluent knowledge of the German language is required.The Site Contracts 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 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 country’s 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 TasksDraft, 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 chainApply 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 – GCPEnsure the best interest of both clients and Parexel are metServes 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 partiesFollow record maintenance and archival guidelines to ensure they are metDevelop and maintain positive relationships with clinical trial sitesDevelop 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 objectivesIdentify potential issues or concerns with contract terms and collaborate with internal stakeholders and clinical trial sites to find mutually acceptable solutionsStay up to date with relevant regulatory requirements, guidelines and applicable laws in respective countryIdentifies 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 AgreementTrack and report on the statuses of site contracting activities to Site Contract Lead, other internal stakeholders and study teamsSCA is responsible for first time quality by self-check and reviews contracts for completeness and accuracyEnsures that changes are appropriately made, approved and documentedWorks within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon contract tracking system in real timeIdentifies possible contract or process operational risk and proactively works with SCL to provide solutionsReviews and complies with Standard Operating Procedures (SOPs) any other relevant applicable guidance in a timely manner, keeps training records updated accordingly and ensures timesheet complianceEnsure adequacy and accuracy of archived recordsIdentify and implement process improvements to increase efficiency and quality in the site contracting processProvide guidance and support to study teams and project management on site contracting matters in the respective countryParticipate in cross-functional communication to identify process improvements and contribute to the development of site contracting strategiesSkills:Possess strong negotiation, diplomacy, and excellent organizational skills with demonstrated experience handling multiple projectsExcellent interpersonal, verbal and written communication skillsStrong problem-solving skillsAbility to successfully work in a “virtual” team environmentMust have strong analytical skills with the ability to create or interpret legal language and budgetsMaintain grace under pressure while displaying a high level of professionalismAlign internal and external resources to achieve objectivesAttention to detailComprehend and interpret contract languageIdentify problems independently and execute solutionsQuickly comprehend desired end-result, goal or objective and act to accomplishPolished presentation skillsQuality-driven in all managed activitiesFluent command of German and English (written and oral) is required in addition to the local language.Knowledge and Experience:Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPointSome experience of working on contracts/agreementsExperience in a CRO or other life sciences industry very desirableEducation:Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experienceOriginally posted on Himalayas