(Director role may be considered for highly qualified candidate)
- Functional Area: Clinical Operations
- Job Type: Full Time, office based
- Required education: BS or advanced degree in physical or life sciences, or equivalent experience. Degree in health sciences field (e.g. nursing, pharmacy, biology) preferred
- Area(s) of expertise desired: Manager: 5+ years of relevant experience in clinical research or pharmaceutical/ biotechnology industry environment. Global experience in oncology strongly preferred.
- Travel: Travel required (anticipated >15%). Travel may include clinical site visits, vendor visits, conferences, and project meetings
About Viracta Therapeutics
Viracta Therapeutics is private biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We will also expand into additional applications to utilize this approach for a range of cancers and virus-associated diseases.
Position Description:
We are currently seeking a full time, office based Clinical Study Manager to join our experienced drug development team in Cardiff, CA. This team member work closely with members of the clinical operations team to provide oversight to clinical trials. We are seeking a strong team player with experience in oncology drug development, strong communication skills, and ability to contribute to a collaborative interdisciplinary environment.
Primary responsibilities of this position include:
- Provide oversight of day to day activity for one or more clinical trial and CRO, including data management, clinical monitoring, data management, and regulatory. Assist clinical operations leadership in ensuring performance of CROs and other external members of the clinical trial team.
- Ensure all aspects of the clinical trial are conducted according to SOPs, applicable regulations, and CFR, ICH, and GCP guidelines
- Assist with the creation of timelines and budgets, and manage trials to meet these targets
- Review trial expenses and external invoices for accuracy. Assist Viracta finance as needed.
- Prepare and present project updates, both written and oral presentations
- Develop training materials and conduct trainings on various aspects of clinical study conduct
- Contribute to the development of clinical trial processes and documents, such as SOPs and executions and oversight plans. Implement and manage processes to ensure compliance.
- Conduct ongoing clinical data review and ensure data quality
- Work with cross-functional internal and external team members, including those in quality assurance, regulatory affairs, finance, and CMC to contribute to overall program goals and deliverables
Qualifications
- Bachelor’s or Master’s degree in related field
- 5+ years of relevant experience managing clinical trials, such as at a CRO or pharma/biotech company
- Strong understanding of GCP compliance and ICH guidelines
- Strong capabilities in Microsoft Office, specifically Excel and/or Project is required.
- Strong collaboration and problem-solving skills
- Excellent written and verbal communication skills
Viracta Therapeutics offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to [email protected] and include the job title in the subject line. No recruiters please.
