We are seeking a Senior Clinical Trials Manager (CTM) to drive our clinical programs to success. The role consists of coordinating clinical studies (primary focus on pre/post-registration but also assisting in registration) designed to generate scientific data to support clinical validity and utility product claims. This role requires a goal-oriented candidate with a willingness to roll up sleeves to achieve company goals. The experienced applicant will report to the Head of Clinical Operations. This role will not be boring! Success will lead to career growth opportunities. On-the-job learning and a desire to say ‘yes’ to new things are expected.
Manages day-to-day operations of one or more clinical trials, ensuring all trial deliverables are met according to timelines, budget, quality standards and operational best practices
Management of all study-related documents (protocol, ICF, CRF, contract, budget)
Ensures compliance with the study protocol and in accordance with the scope of work and in accordance with corporate timelines; identify areas of concern and escalate, as appropriate. Tracks overall study status, assesses risks, and develop mitigation strategies.
Inform management of recruiting issues, propose solutions
Participate in clinical data review of data listings and summary tables, including query generation.
Monitor trial progress/timelines to ensure compliance with and adherence to the project plan
Identify, evaluate and problem solve study-related issues around budget or timelines
Participate in vendor selection, oversee vendors and contribute in any internal or external audits
Contribute to the establishment of standard operating procedures
Interact with cross-functional team members on sample and data analysis to maintain compliance, GCP, data protection and ethical requirements
Ensure local and global healthcare compliance policies are followed
Participate in clinical trial protocol development, site selection, etc.
May manage or mentor junior clinical operations staff as the department grows
Participate in external relationship building (sites, vendors, conferences)
5+ years of clinical operations and/or clinical trials experience
Highly desired to bring experience with IVD device and/or molecular assay studies
KNOWLEDGE, SKILLS, AND ABILITIES:
Ability to use Microsoft Office Suite (Word, Excel, PPT), Adobe Acrobat Reader DC; EDC systems
Excellent verbal and written communication
Efficient time management and organizational skills
Knowledge of emergency medicine, ICU medicine or infectious diseases a plus but not required
Ability to constructively interact directly with clinical site personnel
Excited to ‘wear many hats’, and self-motivated to take on new challenges
Track record of success in a deadline-driven and multi-task environment
Attention to detail and accuracy in work
Available to travel an estimated 25% of the time
Additional Salary Information: Includes equity package
Inflammatix, Inc. is a venture-backed diagnostics company bringing the power of precision medicine to the point- of-care. We are building novel diagnostic, prognostic, and predictive tests that combine rapid detection of human immune gene expression (mRNA) panels with advanced machine learning. These tests will be performed on our rapid point-of-care instrument currently under development. Our first tests, planned to be commercialized in 2021, will enable physicians to better diagnose acute infections and sepsis (including COVID-19)