CRO-Clinical Strategy Project Manager

Clinical Strategy Project Manager

Clinical Strategy Manager/BD Clinical Project Manager

This role plays a critical part in driving business development and clinical operations, contributing to Lotus' growth and its ability to deliver customer-focused outcomes.

Who we are: Home Page - LotusCR.com

Position Overview:

The Clinical Strategy Project Manager, reporting to the Vice President of Business Development, serves as a vital link between the Business Development (BD) and Clinical Operations teams. This position plays a key role in identifying and cultivating new business opportunities for Lotus, offering clinical, therapeutic, and operational expertise to both existing clients and potential new clients.

Working closely with the BD-Sales team and clients, the Clinical Strategy Project Manager ensures that Lotus presents the optimal therapeutic, operational, and country/site strategies for each new opportunity. The role requires active collaboration with clients, Clinical Research Organizations (CROs), vendors, investigators, and study site staff globally to deliver high-quality, effective strategies that meet client needs.

Key Responsibilities:

Business Development & Client Engagement

• Develop and maintain strong, profitable relationships with clients, Key Opinion Leaders (KOLs), investigators, study site staff, and vendors.
• For all assigned opportunities, ensure a thorough understanding of client requirements, project scope, and expectations. Critically review Requests for Proposal (RFPs) and project outlines to ensure a comprehensive approach.
• Contribute clinical and operational expertise to the development of the clinical strategy for new opportunities.
• Review and provide content for client-facing materials, including proposals, bid defense presentations, and marketing materials.
• Attend meetings with potential clients to offer clinical, therapeutic, and operational expertise on pre-award opportunities.
• Conduct ongoing reviews of pre-award feasibility results, adjusting strategies as necessary to ensure that robust and effective clinical solutions are developed for clients.

Business Growth & Expansion

• Represent Lotus at external events, including Bid Defense Meetings, KOL engagements, site/vendor meetings, and scientific conferences.
• Work closely with BD-Sales, Proposals, Budgets and Contracts, and other functional teams to support the transition of new business opportunities from BD to operational teams.

Level-Specific Responsibilities:

Clinical Strategy Project Manager (PM):

• Review and revise therapeutic, operational, and clinical strategy sections of proposals.
• Assume overall responsibility for the final output of key proposal sections, including Executive Summary, feasibility, country and site strategy, timelines, and recruitment plans.
• Work with BD-Sales, Proposals, Budgets, Contracts, functional teams, and CRO vendors (as applicable) to develop study budgets, timelines, and requirements.
• Collaborate with both internal teams (e.g., ERG) and external partners to integrate their contributions into the therapeutic and operational strategies for new opportunities.
• Lead and implement process improvement initiatives within the Clinical Strategy group to enhance efficiency and outcomes.

Minimum Qualifications & Experience:

• Degree in a clinical or life sciences-related field is required. Relevant qualifications or experience in allied professions may also be considered.
• Seven+ years of clinical research experience, including role as a Project Manager or equivalent, in a CRO, biotech, or related environment.
• Proven ability to communicate clearly, prioritize tasks, meet deadlines, and work collaboratively across global time zones.
• Experience in clinical research, pharmaceutical/biotechnology industries, or a related field preferred.
• Familiarity with clinical development processes, therapeutic areas, and regulatory requirements.

Core Skills and Competencies:

• Clinical & Therapeutic Expertise
• Strategic Thinking
• Collaboration
• Problem Solving
• Client-Centric

Qualifications