Clinical Proposal Manager

About Veranex: Veranex is a leading global provider of comprehensive clinical research and consulting services to the med tech/device industries. We specialize in providing end-to-end Clinical Research Organization (CRO) & Consulting solutions for commercial strategy, market access and reimbursement, clinical development including data services, regulatory affairs, and quality assurance, helping our clients bring life-saving therapies to market efficiently and effectively.

Position Overview: Veranex is seeking a talented and experienced individual to join our team as a Clinical Proposal Manager/ Technical Advisor. This role is instrumental in supporting our CRO & Consulting Services department by providing technical expertise, scoping full clinical projects and accurate budgets, crafting comprehensive statements of work (SOW), and change orders (CO) or amendments. The ideal candidate will have a strong background in clinical research, combined with excellent writing, word, PowerPoint and analytical skills.

Key Responsibilities:

• Technical Expertise: Provide technical guidance and expertise in clinical research methodologies, study design, and regulatory requirements to support the proposal development process.
• Project Scoping: Collaborate with Clinical Operations, Data Managers, Biostatisticians, Medical team, and vendors (e.g., Core Labs, EDC companies, eTMF providers) to scope full clinical projects, define project deliverables, and establish timelines and milestones.
• SOW and Amendments Development: Draft detailed budgets, statements of work (SOW) and SOW amendments for clinical projects, ensuring clarity, accuracy, and alignment with client expectations and regulatory guidelines.
• Proposal Writing: Work closely with cross-functional teams to develop comprehensive proposals for clinical research projects, incorporating technical specifications, project timelines, and budgetary projections.
• Budget Development: Collaborate with cross-functional business development team members and vendors to develop detailed project budgets, including resource allocation, cost estimates, and financial analysis.
• Client Communication: Engage with clients to understand their clinical research needs, provide technical insights, and address any questions or concerns related to project scope, budget, or timelines.
• Quality Assurance: Ensure all proposals, SOWs, and amendments adhere to Veranex's quality standards, regulatory requirements, and client specifications.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Biology, Engineering, or related field. Advanced degree (e.g., Master's, PhD) preferred.

• Minimum of 4+ years of experience in clinical research, with a focus on project management, proposal development, or related roles ideally within a CRO or consulting services related environment. Must have medical device experience, in clinical CRO consulting.
• Proficiency in scoping full clinical projects, drafting SOWs, amendments, and developing comprehensive proposals and budgets.
• Strong understanding of clinical research methodologies, regulatory requirements (e.g., ICH-GCP), and industry standards.
• Experience working with clinical data management systems (e.g., iMedNet, Medrio, Veeva Vault) and electronic trial master file (eTMF) systems.
• Excellent communication skills, with the ability to communicate complex technical concepts clearly and concisely in written and verbal formats.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, deadline-driven environment, both independently and as part of a team.
• Proficiency in Microsoft Office Suite (particularly PowerPoint, Excel and Teams), SharePoint and familiarity with project management software/tools.

Why Join Veranex? At Veranex, you will have the opportunity to work with a diverse team of industry experts who are passionate about advancing clinical research, medical device development and improving patient outcomes. We offer competitive compensation, professional development opportunities, and a collaborative work environment where your contributions are valued and recognized. Join us in making a difference in the field of clinical research and healthcare.