Senior Manager, Clinical Operations - Cancer Biology/Genomics

Bluestar Genomics San Francisco , CA 94107

Posted 1 week ago

This position may be either full-time or contract - we're flexible for the right individual.

You will be responsible for implementing and overseeing clinical studies to ensure that trials stay on track with clinical objectives and comply with federal regulations. You will also supervise and mentor CRAs and provide training on internal processes and new regulations.

You will be developing clinical documents (protocols, case report forms, SOPs, etc.), managing CROs and oversight of the data management process. You will work closely with other departments to ensure sample requirements are met and clinical data queries are resolved in a timely manner.



Responsibilities:

  • Collaborate with our Project Manager to set targets for clinical projects (studies, sample sources, data management)
  • Manage operations and relationships with existing vendors (CROs, Clinical Suppliers, etc.)
  • Manage ClinOps activities and resources
  • Provide ClinOps team with appropriate training and learning opportunities
  • Develop and implement study-specific clinical monitoring tools and documents
  • Oversee data monitoring and QC
  • Report metrics on clinical enrollment and data monitoring status
  • Oversee development and management of Trial Master Files
  • Ensure compliance with SOPs and local regulations, and CFR, ICH and GCP guidelines
  • Model our core values: visionary; pioneering; truth seeking; driven; honest and considerate communication; embraces diversity. You are experienced as someone who exemplifies our culture and you operate with transparency and integrity.

Requirements



Skills:

  • Bachelor's degree or equivalent in Biological Sciences or equivalent experience working in Clinical Research for Medical Diagnostic or Device companies - including experience of successful active participation in cross-functional teams - with 5+ years' experience working in a lead role in Clinical Research.
  • Experience working on studies outside of the US preferred
  • Excellent communication and interpersonal skills
  • Ability to build effective relationships with colleagues and study sites
  • Ability to maintain timelines for multiple projects concurrently
  • Proficient with Microsoft Office Suite, including Excel
  • Familiarity with Clinical Databases (Medrio, RAVE, etc.)
  • This position requires being in-house at our San Francisco office at least twice per week.

Benefits

Join our cutting-edge epigenetics diagnostics company!

Come and join our driven, talented and growing company! We are a thoughtful and insightful team of scientists and technologists and our seasoned leadership team has a breadth of experience across industry, teaching and research. Our employees are passionate about genomic diagnostics and improving healthcare.

We provide generous benefits to all employees, including stock options and a fully-stocked kitchen! We value your physical presence in our office in building our cohesive team.

As an exciting life science startup, we are reinventing non-invasive molecular diagnostic testing using next generation epigenomic technologies. We are passionate and dedicated to discovering and developing applications that will make a significant difference in cancer and other epigenomic-driven diseases. Our technologies provide novel insight and quantitation of human health and disease, with our focus on precision medicine applications improving both clinical and health system outcomes. We are building a world-class company, based in San Diego and San Francisco.

We look for extraordinary lifelong learners with a passion and growth mindset for these areas, and for combining biological ingenuity with AI and data analysis. Led by a team with decades of experience bringing products from concept to market, we are an equal opportunity employer and value diversity at our company.

Come join us in addressing large healthcare needs through precision epigenomic medicine

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Senior Manager, Clinical Operations - Cancer Biology/Genomics

Bluestar Genomics