Senior Specialist, Clinical Business Operations

What You’ll Do

MapLight is looking for a dynamic and experienced Senior Specialist, Clinical Business Operations. Reporting to the Executive Director, Clinical Operations, the Senior Specialist will be responsible for supporting all aspects of clinical business operations, including vendor selection, contracts, budget management and performance metrics. The ideal candidate will streamline operational procedures across multiple projects to improve timelines and organization of data.

Responsibilities

• Vendor selection; including review and analysis, budget negotiations, development, and execution.
• Manage the Request for Proposal (RFP) process. This includes:
  • Work with Clinical Trial Managers (CTM) and Clinical Scientific Leads to develop outsourcing strategy including range of vendors and timelines for award (i.e. schedule a vendor outsourcing strategy meeting).
  • Use the RFP template to customize to each study.
  • Create a draft of the RFP for review by the study team.
  • Communicate with vendors the RFP timelines and milestones and coordinate feedback to questions/answers.
  • Maintain the internal RFP timelines and milestones.
  • Following award, be the point of contact to receive the scope of work and budget grid from vendor.
  • Coordinate the review and consolidate the internal study team’s (and finance) questions and comments regarding the budget to the vendor.
  • Coordinate contract review and Coupa entry of budget.
  • Initiate a warm transfer to the operations team.
• Manage MapLight’s review of all site budgets and contracts. This includes:
  • Lead discussions with vendor and CTM to develop study budget and acceptable ranges.
  • Forecast site contract review timelines as they related to study start up with assistance from the study CTM.
  • Laise with the Legal Department to ensure MapLight specific site contract template with fall back language is acceptable.
  • Coordinate with CRO/vendor for process of escalation language to MapLight.
  • Coordinate with study team on internal process for triage of contract language and budget requests.
  • Provide and/or track contract status updates/reporting.
  • Ensure all executed site contracts are filed in the designated area within MapLight.
• Assist with and provide support in developing effective clinical contractual agreements (such as Confidentiality Agreements, Master Services Agreements, Work Orders, Amendments, Change Orders, and any other type of contracts) needed for clinical studies.
• Actively managing other clinical financial obligations.
• Facilitate creation and execution of all contract documents and manage the review and negotiation of contract terms and partner in collaboration with Legal, Finance and other internal stakeholders as needed to finalize.
• Builds and maintains business relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships.
• Innovate and maintain tracking systems and metrics, translating complex data into actionable insights for project and program advancement.
• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understand relationships are key to being successful.
• You are a leader. Teams love working with you.