Clinical Trials Manager

Location
Burlingame, California, United States
Posted
Sep 14, 2020
Ref
4108610003
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY OF ROLE:

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 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.

PRIMARY RESPONSIBILITIES:
  • 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)

QUALIFICATIONS:
  • 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

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

COMPENSATION AND CLASSIFICATION:
  • Classification: Full-time position located at our Burlingame, California headquarters
  • Compensation: Competitive and commensurate with experience; includes equity package.
  • Benefits: Medical, dental, and vision; 401(k) and more.