Clinical Proposal Strategy Manager

Veranex, Inc.Raleigh, NC

About The Position

Veranex is seeking a Clinical Proposal Strategy Manager / Senior Manager to support high-impact clinical business development efforts within our Global Clinical Affairs organization. In this role, you will serve as a central driver of proposal strategy, translating complex clinical trial requirements into competitive, executable, and client-focused proposals. You will partner cross-functionally with Clinical Operations, Business Development, Clinical Data Services, and Subject Matter Experts (SMEs) to develop robust study strategies, timelines, and budgets. This is a high-visibility, client-facing role that blends clinical expertise, operational planning, and commercial acumen—ideal for individuals who thrive at the intersection of strategy and execution in the MedTech clinical CRO space.

Requirements

  • Bachelor’s degree in life sciences, clinical research, healthcare, or related medical/technical field
  • 5+ years of experience in clinical research operations, and/or clinical proposal development within a CRO, with exposure to medical device or MedTech studies
  • Foundational understanding of clinical trial lifecycle, including study design, execution, and regulatory requirements
  • Experience interpreting protocols, schedules of events (SOEs), and scopes of work
  • Ability to translate clinical and operational inputs into structured proposal strategies and plans
  • Experience working in cross-functional environments and supporting proposal development efforts
  • Strong organizational, communication, and problem-solving skills
  • Ability to manage multiple priorities in a fast-paced, deadline-driven environment
  • Bachelor’s degree in life sciences, clinical research, healthcare, or related field
  • 8+ years of experience in clinical research, clinical operations, and/or proposal development within a CRO
  • Deep understanding of end-to-end clinical trial strategy, planning, and execution
  • Proven experience leading cross-functional proposal development
  • Demonstrated ability to translate complex protocols, RFPs, and client requirements into fully executable and competitive proposal strategies
  • Strong experience developing and validating clinical budgets, timelines, and resource assumptions
  • Experience operating in FDA-regulated and ISO-compliant environments
  • Advanced communication and presentation skills, including client-facing interactions and proposal defenses
  • Strong business acumen and ability to balance scientific rigor with commercial considerations

Nice To Haves

  • Experience supporting proposal development in a CRO or consulting environment
  • Exposure to medical device regulatory pathways (e.g., 510(k), IDE, CE Mark)
  • Experience with clinical trial budgeting and vendor coordination
  • Strong focus on medical device studies
  • Advanced degree (MS, MPH, MBA, or PhD) in life sciences or related discipline
  • Experience within a MedTech CRO, professional services, or consulting environment
  • Strong focus on medical device studies
  • Experience supporting regulatory submissions (e.g., 510(k), PMA, IDE, CE Mark)
  • Experience leading complex, multi-stakeholder programs or global studies
  • Familiarity with vendor ecosystems and external partner strategy in clinical trials

Responsibilities

  • Lead and facilitate execution strategies and planning content for clinical trial programs for inclusion in Business Development proposals.
  • Translate RFPs into specific deliverables with supporting project execution strategy, budget, milestones, and timeline.
  • Manage, lead, and facilitate inclusion of Subject Matter Expert content into the proposal execution strategy.
  • Capture and communicate strategic assumptions, risks, and key budget drivers fundamental to the execution strategy.
  • Work closely with Business Development to define compelling strategies, support client positioning, and align solutions to client needs.
  • Present execution strategy details to clients in support of Business Development.
  • Serve as the lead clinical SME for clinical proposal development opportunities, providing strategic guidance on study design, operational feasibility, regulatory requirements, and industry standards.
  • Translate protocols, schedules of events (SOEs), and clinical requirements into executable proposal strategies and project plans.
  • Develop accurate, competitive clinical budgets based on scope, visit schedules, assumptions, and third-party costs.
  • Partner with internal stakeholders to ensure budgets and project plans are executable, compliant, and commercially sound.
  • Participate in client calls to clarify needs, align approach, and strengthen confidence in Veranex’s clinical capabilities.
  • Partner with global SMEs and service line leaders to gather and refine technical and operational proposal content.
  • Collaborate with Proposal Specialists to ensure proposal content is complete, compliant, and submission ready.
  • Lead internal proposal strategy meetings and kickoffs for Clinical opportunities.
  • Support alignment between proposal strategy and downstream study execution expectations.
  • Identify, evaluate, and help establish relationships with key clinical vendors and partners.
  • Support development of internal guidelines, templates, and tools for optimizing clinical study proposal development.
  • Contribute to the growth of Veranex’s clinical text repository, experience database, and reusable content library.
  • Help drive continuous improvement of clinical proposal templates, budget tools, and strategic messaging.
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