Preclinical Study Monitor

Redwood City, CA
Jul 08, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum Biotechnologies is currently looking for a Preclinical Study Monitor who will manage all aspects of the planning, coordination, and conduct of nonclinical studies conducted at our CRO partners. This position will report to the Senior Preclinical Study Monitor.
What you'll do:
  • Serve as the single point of contact with the Contract Research Organizations (CRO), facilitate contracting and protocol development.
  • Provide sound and through oversight of nonclinical study conduct.
  • Coordinate activities of the CROs to ensure compliance with the protocol and study timelines.
  • Coordinate the finalization of study designs, protocol review, and study report cross-functional reviews working with the lead scientists.
  • Draft subreports of study data when necessary.
  • Track deliverables of collected samples, documentation, data, and reports to ensure internal and external alignment and proper coordination of nonclinical studies.
  • Operational responsibilities include tracking contracts, purchase orders and invoices.  
  • Review draft reports for completeness prior to finalization. Coordinate the revisions and finalization of study reports.
  • Responsible for archiving of project documents including nonclinical protocols, reports, data and study related documents.    
  • Maintain accurate and well-organized records and study files

About you:
  • Bachelor’s degree in biological sciences required with 5 years relevant experience.
  • Previous experience working at a CRO is a plus.
  • Previous experience performing bioanalytical work required.
  • Solid understanding of drug development, study design, procedures and documentation practices.
  • Proven knowledge of regulatory requirements, guidances, and good laboratory practices (GLP)
  • Ability to influence and negotiate effective solutions.
  • Ability to work collaboratively within the Preclinical and Research teams as well as cross functionally across the organization to deliver exceptional results and ensure long-term success.
  • Excellent organizational, communication and collaborations skills. Keep accurate records, follow instructions, and comply with company policies. Detail Oriented. Excellent record keeping. Excellent writing and verbal communication skills.
  • Proficiency with Excel, Word, Prism, PowerPoint.
  • Occasional travel is required as part of job duties.

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation