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Global Study Associate

4 months ago

California, United States Neogene Therapeutics Full time

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Why AstraZeneca?

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively affect the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Study Associate, Cell Therapy is responsible for supporting the delivery of cell therapy clinical studies by providing administrative and system support. The Study Associate will work across several studies, so a high degree of flexibility is required. The exact accountabilities will differ depending on the nature of the clinical program or study. You will report to the Director Study Leader, Cell Therapy or equivalent.

Essential Skills:

Collect, review, and track relevant study documents.
Support setup, maintenance, closeout and archiving of the Trial Master File (TMF), including restricted TMF sections for Cell Therapy-specific documents. Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
Support production of study documents, ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system.
Set-up, populate and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems.
Manage and contribute to the coordination and tracking of study materials and equipment.
Assist in the tracking and reconciliation of invoices.
Support study team and provide study metrics/reports during the study, audits, and regulatory inspections.
Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g., study team meetings, monitor meetings, investigator meetings and advisory boards.
Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents.
Prepare and distribute study-related correspondence. Contribute to and distribute materials for meetings, newsletters, and websites.

Experience and Education
Bachelor's degree plus 1+ years, Associate's degree plus 6+ years or High School plus 10+ years of experience
Minimum of 1-2 years' experience of administrative/operational support of clinical studies
Knowledge of ICH-GCP principles
Team oriented
Ability to coordinate and prioritize multiple tasks and deliverables
Proactive approach to accomplishing study goals
High degree of flexibility
Demonstrated verbal and written communication skills

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office.
The annual base salary for this position ranges from $79,000 to $119,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience.
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program
401(k) plan
Paid vacation and holidays; paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage.

Ready to join our team and make a difference? Apply now
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), and work authorization and employment eligibility verification requirements.
DE&I Statement

Headline: We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
A collaborative culture that leverages the diverse perspectives of employees and supports courage
Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."