Associate Site Contract Lead

6 days ago

Beijing, Beijing, China Hiro Full time CN¥900,000 - CN¥1,200,000 per year

该职位来源于猎聘 This position manages clinical study agreements (CTAs) on a study level and drives CTA document finalization and execution, including contractual language & terms. Ensures CTA negotiation comply with sponsor and Company requirements. Works with internal and external team members to provide and implement solutions. Establishes strong working relationships with customers and internal project teams. May serve as strategic point of contact for internal and external customers to meet site contracting goals.

  • Provides oversight of contact negotiations status and manages escalation of out-of-parameter queries on contractual requests to sponsor decision-makers in all regions of study conduct. Provides consultation during escalation of out-of-parameter queries as needed.
  • Plans contract execution strategy for assigned studies—including forecast of site-specific contractual execution timelines with as much accuracy as possible—and coordinates with internal study team stakeholders to ensure that CTA strategy is aligned with overall study start-up plans and expectations overall. Manages expectations of internal and sponsor study team regarding global CTA negotiations for assigned studies.
  • Acts as first-line subject matter expert for all such CTA elements on assigned studies for internal and sponsor stakeholders alike. Advises stakeholders on issue resolution within the context of assigned studies. May seek additional support from internal support structures as needed.
  • Participates in regular study calls to facilitate communication as needed.
  • Works closely with internal stakeholders and with Sponsor to prepare site contractual templates, including payment terms, and study-level negotiation parameters and processes within Company standards in order to drive successful negotiation of contracts and budgets. Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program.
  • Creates and maintains document status reports, and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.
  • Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
  • Manages site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
  • Performs other work-related duties as assigned. 任职要求:
  • Minimum of 2 years of progressive experience leading site contract negotiations in clinical research industry.
  • Thorough knowledge of applicable regulations, drug development and clinical project management procedures.
  • Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), MS Project, outlook and Internet.
  • Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
  • Attention to attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines. Strong leadership skills; ability to teach/mentor team members. Legal background, or equivalent combination of education and experience. Competent in written and oral English and local language.

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