Nonclinical Study Specialist (Study Management)

Location: South San Francisco, CA

Department: Research

Type: Full Time

Min. Experience: Experienced

Position Summary:    

Supports all aspects of the design, planning, and implementation of internal or external nonclinical research projects. Supports conduct of pre-study, initiation, and interim nonclinical study monitoring visits. Coordinates activities of internal research groups and Contract Research Organizations (CROs) to ensure compliance with protocol and study timelines. May participate in the conduct of internal studies or periodically travel to CROs to monitor the progress of outsourced studies. Participates in and coordinates nonclinical study protocol review and finalization in collaboration with the program Research Scientist, Toxicologist, Pharmacologist and/or Pharmacokineticist. Facilitates the review and finalization of all nonclinical reports. Supports the contractual process with CROs and tracks study expenditures against budgets. Responsible for nonclinical study data management, QC and report archiving. May support study conduct or outsourcing of other research functions as necessary.

 

Essential Functions:

  • Responsible for outsourced nonclinical studies from identifying CROs to study finalization.
  • Provide hands-on support in designing, conducting and reporting of in-house studies, including systems development (e.g. report templates, study tracking, etc.).
  • Coordinates all aspects of nonclinical study conduct under the direction of the project Research Scientist, Toxicologist, Pharmacologist or Pharmacokineticist.
  • Serve as the single point of contact with CROs, facilitates contracting and develops the protocol under the direction of the project scientist in collaboration with the Study Director.  
  • Monitor studies and provide written monitoring reports.
  • Review study data and draft report prior to submission to the project scientist, presents the data in PowerPoint or other formats when needed, and coordinates the review, revision and finalization of nonclinical reports.
  • May participate in quality assurance audits of CROs.
  • Operational responsibilities include tracking budgets, purchase orders and invoices to ensure that the company’s vendors are paid in a timely fashion and that all work product received meets project requirements.  
  • Maintain study database to track adherence to study and project milestones.
  • Will participate in project teams and departmental meetings and assist in preparing reports for regulatory submissions.
  • Responsible for archiving of project documents including nonclinical protocols and reports.    
  • Maintain accurate and well-organized records and worksheets.
  • Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with laboratory animals, chemicals or pharmaceutical agents.
  • Excellent computer skills are required. Working knowledge of MS Word, Excel, Power Point, Asana, Slack and SharePoint is a plus.

 

Preferred Education:

 

  • A Bachelors degree in a scientific discipline is required.  Equivalent experience may be accepted.
  • A Masters degree with less experience will be considered.

 

Preferred Experience:

  • A minimum of 7 years experience in the Pharmaceutical, Medical Products industry, Contract Research industry, pharmaceutical product development, including in a GLP environment is required.
  • Specific experience in nonclinical study monitoring required. Hands-on experience as laboratory animal technician is a plus.
  • Must have in-depth knowledge of FDA, EMEA and ICH Guidelines and mastery of Good Laboratory Practice (GLP) regulations governing the conduct of nonclinical studies.
  • Excellent written, and verbal as well as instant messaging communication skills.
  • Must be highly organized, able to work independently and prioritize multiple tasks.
  • Excellent computer skills are required.  Working knowledge of MS Word, Excel, Power Point, Asana, Slack and SharePoint is a plus.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Ability to travel domestically and internationally.

 

 

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