We are seeking a 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 into the Head of Clinical Operations. The position will be based in our Burlingame offices, but the applicant may work remotely part time. 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 trials deliverables are met according to timelines, budget, quality standards and operational best practices
- Management of all study related documents (protocol, ICF, CRF, contract, budget)
- Creation and maintenance of trial master file (TMF)
- Contribute to the establishment of standard operating procedures
- Maintain communication (teleconferences, newsletters) with clinical site staff to track progress, assess risk and develop mitigation strategies.
- Define trial recruitment plan, inform management of recruiting issues, propose solutions
- Oversee or perform monitoring activities per study plans, provide guidance on site issues
- Participate in clinical data review
- Participate in vendor selection, oversee vendors and contribute in any internal or external audits
- Interact with cross-functional team members on sample and data analysis to maintain compliance, GCP, data protection and ethical requirements
- May manage or mentor junior clinical operations staff as the department grows
- > 5 years of clinical operations and/or clinical trials experience or similar (CRA/CTM)
- Highly desired to bring experience with IVD device and/or molecular assay studies
- Ability to use Microsoft Office Suite (Word, Excel, PPT), Adobe Acrobat Reader DC; EDC systems
KNOWLEDGE, SKILLS, AND ABILITIES:
- Knowledge of emergency medicine, ICU medicine or infectious diseases a plus but not required
- Ability to constructively interact directly with clinical site personnel
- Track record of success in a deadline-driven and multi-task environment
- Attention to detail and accuracy in work
- Available to travel an estimated 30% of the time
SALARY AND CLASSIFICATION:
Compensation: Competitive and commensurate with experience; includes equity package.
HOW TO APPLY: Please forward a cover letter and resume to: jobs [at] inflammatix [dot] com