[Hiring] Clinical Trial Manager @Tyra Biosciences

Role Description

The Clinical Trial Manager will play a key contributor role in the strategic implementation and execution of the clinical trial from study start up to close-out. The position is responsible for the management and oversight of CRO’s, study vendors and clinical trial sites, and will partner with key internal stakeholders to ensure clinical trial deliverables are completed on-time, within budget, and in accordance with regulatory requirements, GCP guidelines and internal SOPs.

Qualifications

• Bachelor’s degree in life sciences
• Minimum 6-8 years relevant work experience of hands‐on, independent clinical trial support experience within a pharmaceutical or biotech environment
• 1-2 years in a CTM role preferred
• Extensive experience required overseeing and managing early phase and global registrational clinical trials
• Experience managing external vendors and CROs, including leading vendor team changes
• Strong project management skills required
• Extensive knowledge of ICH/GCP and FDA regulations, clinical trial processes and protocols
• High competency with electronic systems such as eTMF, CTMS, EDC, or other related systems
• Ability to work independently with minimal direction/oversight and within a team structure
• Ability to think critically in fast‐paced environment with a keen sense of urgency and a demonstrated ability to problem solve
• Must have excellent interpersonal, written, verbal communication, computer, organization and administrative skills
• Proficiency in MS Office applications and comfortability with technology
• Minimal travel required (5 to 10%)

Requirements

• Support the clinical operations team in the successful execution of the clinical trial from protocol concept to clinical study report
• Assist in study set‐up including but not limited to protocol/synopsis preparation, informed consent form preparation and review, systems (i.e., CTMS, IRT), and regulatory submissions
• Prepare and maintain study related files
• Organize study and departmental meetings, take minutes, and ensure all study documentation is appropriately archived
• Coordinate clinical trial equipment and supplies
• Coordinate cross‐functional project related activities (e.g., Clinical Data Review Meetings)
• Ensure clinical team compliance with all required study specific training
• Perform TMF reviews to ensure completeness
• Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections
• Assist with budget management
• Support the day‐to‐day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements
• Activities may include tracking of appropriate subject and site activity/metrics, performing quality check activities across components of the clinical study, and other related activities
• Proactively identify and escalate issues that arise related to support functional deliverables
• Collaborate with CRO on the timely collection and archiving of TMF documents for assigned studies/programs
• Coordinate with regulatory affairs on the ongoing submission of essential documents to regulatory authorities
• Assist in the management of study completion activities with the CRO and the sites including TMF reconciliation, drug reconciliation, ensure that all documents are available for the CSR
• Effectively communicate with study team members and work closely with Clinical Trial Managers and/or Asset Leads
• May participate in process improvement and quality‐related initiatives associated with study execution and deliverables
• Work to ensure the achievement of study timelines including FPI, enrollment targets, site activation, and data cleaning goals

Benefits

• Competitive base, bonus, new hire and ongoing equity packages
• Employer-paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance