Senior Specialist, Clinical Business Operations

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 Map Light’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 Map Light specific site contract template with fallback language is acceptable.
  • Coordinate with CRO/vendor for process of escalation language to Map Light.
  • 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 Map Light.
  • 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 manage 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.
• Build and maintain business relationships and establish 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.
• Participate and work effectively with multiple cross-functional teams.
• Have strong interpersonal skills and understand relationships are key to being successful.
• Be a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• Be a team player who is willing to roll-up your sleeves and get the job done.

• Bachelor’s Degree or equivalent education required, preferably in Life Sciences, Finance, or Business Administration.
• A minimum of 3 years experience with outsourcing for clinical trials, vendor negotiations, or operations management, accounting, and finance.
• Experience working with the biotech/pharmaceutical industry at a CRO or sponsor company preferred.
• Experience working with key Clinical Operations stakeholders.
• Excellent written and oral communication skills with ability to generate concise reports and verbal updates.
• Demonstrated strong analytical skills.
• Demonstrated high level of proficiency with Microsoft Office suite (Outlook, Word, Excel, PowerPoint).
• Must be flexible and adaptable to changing project priorities, work assignments and deadlines.