Sr. Clinical Trial Manager

We are seeking a Sr. Clinical Trial Manager (CTM) to drive our clinical programs to success. The role consists of coordinating clinical studies (registration, pre-registration and post-registration) designed to generate scientific data to support clinical validity and utility product claims, as well as achieve regulatory approval as part of FDA and CE mark filings. This Sr. CTM will also assist in establishing our Clinical Operations group. 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 Chief Medical Officer (CMO) and may work remotely and independently but must be available for onsite team meetings as necessary. 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.

PRIMARY RESPONSIBILITIES:

  • Responsible for ensuring all trial deliverables are met according to timelines, budget, quality standards and operational best practices
  • Management of all study related documents (NDA, protocol, CRF, contract, budget, invoicing)
  • Creation and maintenance of all trial files, including the trial master file, and oversight of site files
  • Communicates with IRBs/Ethics Committees, maintains and provides the necessary documents
  • Provide and/or facilitate training to CROs, investigators, clinical study teams on protocol requirements, maintain communication with clinical site staff
  • Define trial recruitment plan, inform management of recruiting issues, propose solutions
  • Manage the hiring, training andoversight of Study Monitors and provide guidance on site issues
  • 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
  • Provide updates to trial investigators and study teams (reports/guidance, newsletter)
  • Participate in internal and external audits
  • Establish standard operating procedures
  • Interact with Medical, Biostatistics and R&D teams on sample and data analysis to maintain compliance, GCP, data protection and ethical requirements
  • Facilitate personal development of clinical staff, including training and fostering career growth

QUALIFICATIONS:

  • > 10 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
  • Preferred degree: biology, microbiology, nursing, chemistry or science
  • Ability to use Microsoft Office Suite (Word, Excel, PPT), Adobe Acrobat Reader DC; experience with Medrio is a plus
  • Available to travel an estimated 30% of the time

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Preferred residence in Northern California, Bay Area
  • Excellent verbal and written communication
  • Knowledge of infectious diseases or emergency or ICU medicine a plus but not required
  • Strong leadership skills
  • 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
  • Well organized and detail oriented

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

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2018-12-04T19:14:50+00:00