Our small start-up client is adding a Sr. Clinical Trial Manager (CTM) to the team! The CTM will report to the Executive Director of Clinical and will play a critical role in conducting a successful clinical study.  As an internal and externally facing position, this position interacts directly with the internal study team, regulatory affairs, legal, marketing, and R&D, along with clinical vendors, physician consultants, clinical Investigators, and other study staff at a clinical research site.  The CTM will oversee the execution of the study to ensure patient safety, maintain the quality and. integrity of the study data, and meet good clinical practice requirements. 

Your role with the company:

• Responsible and accountable for one or more clinical studies
• Coordinate all aspects of the clinical study from study start-up through closeout
• Manage the clinical studies within the approved budgets and timelines
• Collaborate with clinical advisors during the development of a clinical protocol
• May participate on a cross-functional core team to support the ongoing development of the study device
• Support the identification of clinical vendors such as CROs, core labs, or others
• Manage deliverables agreed to with chosen clinical vendors to ensure adequate delivery, quality, timeliness, and cost-effectiveness
• Oversee the investigator and investigational site selection process
• Develop clinical study documents such as protocols, CRFs, training materials, informed consent, operational plans and required forms
• Manage forecasting and accountability of study devices
• Development, tracking, and report out of study metrics
• Identification and escalation of potential patient safety concerns, compliance issues, and other study risks
• Responsible for ensuring the audit-readiness of the study throughout the study duration

Desired Profile:

• Bachelor’s degree in life sciences, biological sciences, pharmacy, nursing, biomedical engineering, or related field
• Minimum 5 years of clinical research experience with at least 1 year of project management responsibilities
• Knowledge of good clinical practices, ICH, HIPAA, and other applicable clinical trial-related regulations
• Experience with pre-market IDE clinical trials (Feasibility and Pivotal preferred)
• Ability to provide clear direction and guidance to others
• Strong communication, interpersonal, and problem-solving skills
• Excellent organizational and time management skills
• Proven ability to work independently in a fast-paced environment
• Ability to travel up to 35% primarily within the US