- Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with moderate oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as technical expert across all Site Contracts functions. Trains and mentors junior team members and proactively identify ways to improve internal project operations. Establishes strong working relationships with customer, internal project teams and sites. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
May participate in internal team education or process improvement initiatives.
・Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
・ May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
・Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site.
・Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
・Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
・Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
・Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
・Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
・Supports in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
・Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
・Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
・Facilitates the execution of contracts by company signatories.
・Maintains contract templates and site specific files and databases.
・Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products. Maintains and updates training material for site contract team.
・Acts as a 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.
・Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
・Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
- ・BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
・Advanced degree preferred.
・High level of contracts management experience.
・Experience in a contract research organization or pharmaceutical industry essential.
Strong knowledge of the clinical development process and legal and contracting parameters.
・Strong computer skills in Microsoft Office Suite.
Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.
・Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
・Good understanding clinical protocols and associated study specifications.
・Excellent understanding of clinical trial start-up processes.
・Project management experience in a fast-paced environment.
・Good vendor management skills.
・Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation.
・Strong organizational skills with proven ability to handle multiple projects excellent communication.
・Quality-driven in all managed activities. Strong negotiating skills. ・Strong problem-solving skills.
・Ability to mentor, lead and motivate more junior staff.
・Demonstrate an ability to provide quality feedback and guidance to peers Contribute to a training and Quality assurance plan within SSU and update SOPs/WI.
- 【住所】 東京
- 完全週休2日制(かつ土日祝日) 有給休暇10日～20日 休日日数120日
- ＜教育制度・資格補助補足＞ ・社内e-learningシステムINC Collegeによる各種研修プログラム ・英教育最大手ピアソンが提供するGlobal Englishの無料受講