Senior Clinical Research Manager

Position Summary

Transpire Bio is seeking a Senior Manager Clinical Research to provide operational leadership for the planning, execution, and oversight of clinical studies. This individual will manage multiple clinical studies and work closely with internal cross-functional teams, clinical sites, contract research organizations, and other external partners to deliver studies in accordance with approved protocols, timelines, budgets, quality standards, and applicable regulatory requirements. The successful candidate will combine strong clinical operations experience with sound judgment, attention to detail, and the ability to manage competing priorities in a fast-paced biotechnology environment. The Senior Manager serves as an integral part of the team and represents clinical as a core team member in the respiratory pipeline.

Key Responsibilities:
• Lead the operational planning, start-up, execution, oversight, and closeout of multiple clinical studies, including management of scope, timelines, milestones, risks, and deliverables.
• Develop and maintain study plans, timelines, trackers, risk logs, enrollment projections, and other clinical operations tools needed to support effective study execution.
• Oversee CROs, clinical sites, laboratories, and other vendors; establish clear expectations, monitor performance, address issues, and escalate significant risks when appropriate.
• Coordinate site feasibility, site selection, study start-up, investigator meetings, enrollment activities, monitoring, study conduct, and site closeout activities.
• Partner with Clinical Development, Medical, Regulatory, Data Management, Biostatistics, Clinical Supply, Quality, and other functions to support integrated study delivery.
• Lead, support and review protocols, informed consent forms, study manuals, monitoring plans, case report forms, site materials, and other study documents for operational feasibility and consistency.
• Monitor study progress and key performance indicators, including activation, enrollment, data quality, protocol deviations, monitoring findings, and corrective actions.
• Ensure clinical trial documentation is complete, accurate, inspection-ready, and maintained in the electronic trial master file in accordance with company procedures and applicable requirements.
• Support study budget development, invoice review, forecasting, contract oversight, and change-order assessment in partnership with Finance and Procurement.
• Identify operational risks early, facilitate practical mitigation plans, and communicate study status, decisions, and issues clearly to clinical leadership and study teams.
• Participate in vendor governance meetings, investigator and site meetings, data review meetings, co-lead meetings with vendors and other study-related forums as needed.
• Review emerging clinical data, protocol deviations, enrollment trends, and study risks; facilitate cross-functional evaluation and escalation of clinically or operationally significant findings
• Support audits, inspections, quality investigations, and corrective and preventive actions related to assigned clinical studies.
• Contribute to the development and continuous improvement of clinical research processes, standard operating procedures, templates, and best practices.
• Travel approximately 20–25% to clinical sites, investigator meetings, vendor meetings, and other business locations.

Required Qualifications:
• Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline; an advanced degree is a plus.
• Six or more years of progressively responsible clinical research or clinical operations experience in the biotechnology, pharmaceutical, medical device, or CRO environment.
• Demonstrated experience managing or providing significant operational leadership across multiple clinical studies, including experience balancing concurrent study priorities.
• Experience overseeing CROs, clinical sites, and external vendors throughout the clinical study lifecycle.
• Working knowledge of ICH Good Clinical Practice, FDA requirements, and other applicable clinical research regulations and standards.
• Experience with study start-up, site management, monitoring oversight, enrollment management, trial master file oversight, and study closeout.
• Excellent organizational skills with experience in project management, problem-solving, organizational, and vendor-management.
• Ability to analyze study metrics, identify emerging risks, and drive timely decisions and corrective actions.
• Strong written and verbal communication skills, with the ability to work effectively across functions and with external partners.
• Self-starter with experience working independently.
• Demonstrates flexibility and adaptability.
• Working skills in computer applications, such as Microsoft Word, SharePoint, Excel, PowerPoint, and Outlook
• Ability and willingness to travel 20–25%, including internationally.

Preferred Qualifications:
• Clinical research experience in respiratory, pulmonary, inhalation, or drug-device combination products.
• Experience supporting Phase I through Phase III clinical studies and working in a small or growing biotechnology company.
• Experience with electronic data capture, clinical trial management, and electronic trial master file systems.
• Experience supporting regulatory submissions, audits, or health authority inspections.

Contract Assignment

This position is structured as a one-year contractor assignment. Any extension, renewal, or conversion to regular employment will depend on business needs, performance, available funding, and mutual agreement and is not guaranteed. The contractor must comply with Transpire Bio policies, confidentiality requirements, training requirements, and applicable clinical research and quality standards while performing services for the Company.

Equal Opportunity

Transpire Bio is committed to providing equal opportunity. Employment and contracting decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable law.