Manager, Clinical Operations Projects

 

Evolve BioSystems, Inc. – Davis, CA

Reporting to the Director of Clinical Development & Operations, the Manager, Clinical Operations Projects will be responsible for managing the execution of multiple clinical trials from study start-up to final data reporting. This person will collaborate with leadership and the cross functional team to design and oversee clinical trials that support commercialization strategies, regulatory requirements, and product development. This person thrives in a fast-paced, entrepreneurial, start-up environment.

Key Responsibilities:

  • Generate clinical trial documents – protocols, informed consent forms, CRFs, study reports, plans, SOPs
  • Coordinate site selection – feasibility questionnaires, investigator evaluations
  • Maintain strong working relationships with site staff and KOLs
  • Perform contract and budget negotiations
  • Manage third-party vendors – database partners, statistical services, CROs
  • May occasionally monitor study data
  • Manage site payments and budgets
  • Train study site personnel
  • Coordinate production of clinical trial materials with Supply Chain team
  • Coordinate study specimen collection, including tracking and logistics
  • Analyze data and draft manuscripts and reports

Knowledge, Skills and Abilities:

  • Passion for Evolve’s mission

  •  Ability to manage projects independently from start to finish and meet deadlines

  • Execution-oriented with the ability to achieve accuracy and thoroughness

  • Ability to thrive in an entrepreneurial, fast paced, and dynamic environment

  • Ability to multi-task and prioritize objectives

  • Comfortable interacting with all levels of management, including senior leadership

  • Strong interpersonal, communication, and influencing skills

  • Comfortable sharing scientific information

  • Professionalism with physicians and other medical professionals

  • Excellent writing skills for clinical trial document generation

  • Basic data analytical skills

  • Strong financial acumen; budget management

  • Strong technical aptitude with web-based tools and electronic data capture systems, and intermediate to advanced proficiency of the Microsoft Office Suite

  • Willingness to travel domestic and international (when required) up to 20%

Ideal Experience/Education:

  • BA/BS or RN degree required

  • Minimum 5-7 years Clinical Trials experience in industry (pharma/biotech/CRO) or at a clinical research site

  • Thorough understanding of FDA and/or EMA regulations, ICH guidelines, and GCP standards for the conduct of human clinical trials required

  • Experience in clinical trials of probiotics or biologics is a plus!

  • Experience in clinical trials with babies or pregnant women is a plus!

 


Interested in this position? Please email your resume to: rflannery@evolvebiosystems.com