Clinical Trial Manager

Our client is an innovative clinical-stage biotechnology company advancing next-generation therapeutics through proprietary localized, extended-release drug delivery technology. Their platform is designed to precisely target treatment to specific tissues, with the potential to enhance safety, tolerability, efficacy, and duration of effect while reducing systemic exposure and side effects often associated with conventional delivery methods. The company is currently progressing programs in pain and inflammatory gastrointestinal disease, with broader future applications across oncology, infectious disease, and other areas of significant unmet medical need. This is an exciting opportunity to join a science-driven organization focused on transforming how established and novel therapies are delivered to patients.



Scope:
As our client's Clinical Trial Manager (CTM) you will be primarily responsible for the operational management and oversight of clinical studies. You will also help us build our clinical operational infrastructure and teams.
Travel Requirement: Must be willing to travel domestically and internationally (approximately 20%), as needed

Primary Responsibilities:

• Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Independently developing the trial's timelines, budgets, key deliverables, and risk/mitigation strategies
• Leading the development of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
• Planning and leading study team meetings
• Managing, mentoring, and training clinical operational staff
• Leading the identification and engagement of CROs and other third-party study vendors
• Managing and improving performance of third party vendors and field CRAs to ensure compliance with study protocol and consistency with scope of work; identify areas of concern and escalate as appropriate
• Identifying, selecting, and monitoring performance of investigational sites; ensuring accurate and timely site visit reports
• Developing and maintaining good working relationships with investigators and study staff
• Negotiating and managing the budgets and payments for investigative sites
• Tracking and ensuring optimization of site startup activities and activation, subject enrollment, data collection, and study closeout
• Ensuring completeness and accuracy of Trial Master File
• Managing investigational product release packages and investigational product accountability
• Performing clinical data review of data listings and summary tables, including query generation
• Other duties as assigned

• Bachelor's degree or equivalent in life sciences
• At least 6 years of clinical operations experience in the pharmaceutical industry with significant knowledge of GCP/ICH guidelines and the clinical development process
• At least 1 year of experience managing industry sponsored pharmaceutical clinical trials as a sponsor employee
• Ability to plan, organize and conduct clinical trials with minimum oversight
• Experience leading, managing, or mentoring clinical operational staff and cross-functional teams
• Significant experience managing CROs and other vendors and assessing performance and finances (e.g., invoice review, change order management, and budget reforecasting)
• Strong interpersonal, communication (written and verbal), and organizational skills
• Able to motivate a team to work effectively
• Able to solve problems under pressure