ERGOMED

Senior Site Contracts Manager

ERGOMED

full-time

Posted on:

Origin:  • 🇺🇸 United States • North Carolina

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Job Level

Senior

About the role

  • Due to the continued growth of our Global Study Start Up Group, we are now seeking a (Senior) Site Contracts Manager who will be responsible for overseeing the negotiation process of clinical study agreements on assigned trials, and who will act as a subject matter expert to our sponsors and stakeholders.
  • The Senior Site Contracts Manager will be responsible for (but not limited to) the following activities: Oversees negotiations of clinical study agreements (CTAs) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator budgets.
  • Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers.
  • Plan the Clinical Site Agreement (CSA) execution strategy for assigned studies in line with overall study start-up delivery plans and client expectations.
  • Work closely with internal and external stakeholders to prepare the necessary Clinical Site Agreement templates, payment terms, as well as fallback positions and negotiation parameters in line with Ergomed’s standards.
  • Lead CSA negotiations on a study level and drive the finalization and execution of CSAs as per planned timelines.
  • Create and maintain document status reports’ and update department tools/systems and team members on a regular basis; Ensure appropriate documentation is maintained by Ergomed staff assigned to the contracting process.
  • Manage 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.
  • Establish strong working relationships and collaboration with Sponsor to ensure smooth negotiations and repeat business with Ergomed.
  • Be accountable for Site Contracts delivery of assigned projects and/or initiatives.
  • May oversee people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counselling
  • Perform other work-related duties as assigned.

Requirements

  • BS degree in law, business, life sciences, a health-related field, or equivalent combination of education and experience.
  • Strong CRO operational experience with a track record of success in Site Contracts Management working in an international or global capacity.
  • Thorough knowledge of applicable regulations, drug development and clinical project management procedures.
  • Understanding of the specific country/ sites requirements pertaining to Site Contracts delivery in North America
  • Good presentation, documentation and interpersonal skills.
  • Proficient in MS Office (Word, Excel and PowerPoint), 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 lesser experienced team members.