Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The opportunity:
As the Clinical Trial Lead (CTL), you will be responsible for the successful execution of clinical study team deliverables by effectively directing, supporting, and overseeing team activities to plan. You'll work closely with the Clinical Project Manager (CPM) and all applicable cross-functions (e.g. Clinical Development, Data Management, Regulatory, Quality, etc.) to understand, prioritize, and supervise clinical study team activities in line with the project budget, timeline, and all applicable regulatory and ICH/GCP requirements.
What you'll be doing:
- Plan and manage Clinical Research Associate/Clinical Trial Associate (CRA/CTA) activities and workload.
- Set expectations and prioritization for sponsor level monitoring and oversight, including but not limited to: monitoring visit report review, clinical deviation review, management of clinical quality events, creation and management of sponsor oversight events, clinical trial tracking, management of trial master file, etc.
- Ensure all startup, maintenance, and closeout activities delegated to clinical study team members, including oversight of CRO activities, are tracked and completed to plan.
- Ensure internal and external communication pathways are in place to support timely reporting of trial information and effective issue escalation/resolution.
- Ensure accuracy and feasibility of clinical study plans and trial specific procedures.
- Create/review clinical trial tools to support consistent/efficient CRA/CTA activities as needed.
- Monitor the quality of clinical study team activities and addresses issues as required.
- Support risk mitigation strategies and ensure issues identified by clinical study team members are adequately resolved in line with all project, quality, and regulatory requirements.
- Ensure ongoing adherence to company and study standard processes and act to proactively address training needs.
- Ensure REGENXBIO clinical systems are up to date and that issues are promptly escalated/resolved.
- Lead/perform vendor management activities as required.
- Support execution of clinical trial related activities as required.
- Liaise with cross-functional staff and the CPM to provide metrics and/or status updates as needed.
- Ensure timely processing of invoices by clinical team members as applicable.
- Provide guidance and mentorship to CRAs/CTAs.
- Monitor CRA/CTA time and supplies the CPM and/or Clinical Operations Lead with information required to make project resourcing and FTE decisions.
- Attend and support cross-functional Clinical Trial Team meetings as required.
- Travel up to 25% of the time is required
- It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
What we're looking for:
- Bachelor’s degree required with an emphasis on Life Sciences (or equivalent work experience).
- Minimum 6 years clinical research experience with at least 4 years clinical research associate experience (clinical monitoring experience preferred).
- Experience in managing all stages of clinical research (study startup through closeout preferred).
- Must have working knowledge of ICH/GCP principals and demonstrate a working knowledge of clinical trial execution.
- Demonstrates familiarity with industry standards.
- Ability to work in a dynamic, fast paced, team environment.
Why Should You Apply?By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. Apply for this job
