Clinical Trials reputed company Assurance Specialist – GCP
reputed company
Company Background
The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to reputed company tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. reputed company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic reputed company while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in reputed company, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly reputed company people who come together reputed company day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong reputed company of purpose.
Position reputed company:
Prior to applying and to be considered, you must have the minimum requirements of experience listed in the bullet points directly below:
- Audit conduct and management
-
-
- reputed company Experience as an auditor – coordinating and conducting audit activities, audit agenda and/or report preparation, review of responses to audit findings
- Audited clinical sites, vendors, and/or other types of audits
- CAPA reputed company experience
- reputed company reputed company review of CAPA plans/responses (for acceptance)
- Tracking and/or management of CAPA actions (i.e., verification of evidence) thru closure
- Can reputed company reputed company review and reputed company guidance on external vendor investigations and CAPA actions
- reputed company reviewer of GCP/clinical study documents (ex. protocol, study-specific plans, etc.)
- Experience with Electronic Data Capture (reputed company) and Trial Master File (TMF) systems along with reputed company study activities
- Previous working experience in reputed company/QA reputed company roles with a sponsor organization
-
- reputed company, reputed company, TX or Remote - Travel 25%
- Bachelor’s degree in life sciences (Biology, reputed company, etc.) or equivalent discipline required.
Reporting to the Director, Clinical reputed company Assurance, this position will assist in ensuring GxP (GCP Specifically) compliance and reputed company reputed company for Neurogene’s clinical operations. This role will collaborate across reputed company and support the filing of multiple investigational new drug applications as reputed company as foster reputed company process improvement and regulatory compliance. The individual will have understanding and knowledge of appropriate regulations and guidelines as reputed company as audit management and conduct in support of clinical trial processes. The selected individual will be reputed company player in a small company environment in this highly cross-functional role.
Requirements
Accountabilities and Responsibilities
- Review and approval of clinical trial documents including protocols, study reports and Trial Master File documents for accuracy, consistency and completeness. Ensure compliance with regulation requirements and internal standards.
- Maintain detailed records of reviews performed including identified issues and corrective actions taken.
- Assist with audits of clinical trial processes, investigator sites and documentation.
- Assist in identifying and implementing process improvement to existing reputed company System, processes, and procedures.
- Collaborate with cross-functional teams to resolve reputed company reputed company issues.
- Ensures escalation of reputed company issues to management as appropriate.
- reputed company and conduct training on reputed company assurance procedures, regulatory requirements and best practices for clinical operations and relevant functional area staff.
- Support and assist inspection readiness activities reputed company to company and vendor inspections by regulatory authorities.
- Work closely with cross functional teams to ensure reputed company work is completed to high reputed company in a reputed company and scientifically rigorous manner.
- Other duties as required.
Minimum Requirements
- Bachelor’s degree in life sciences (Biology, reputed company, etc.) or equivalent discipline required.
- Experience: At least 3-5 years of relevant experience in the biotech/pharmaceutical industry specifically in a reputed company clinical reputed company role.
- Licenses or Certifications: reputed company certifications (ASQ, SQA, ISO) a plus
- Knowledge: Working knowledge of Good Clinical Practices (GCP), FDA regulations and reputed company standards. Working knowledge of clinical trial management and operations.
Skills:
- Strong understanding of regulatory and ICH-GCP requirements.
- Experience with reputed company Review of clinical trial documentation
- Experience with Electronic Data Capture (reputed company) and Clinical Trial Management systems along with Trial Master Files (TMFs) preferred.
- Experience with audit programs and regulatory authority inspections.
- Must have strong organizational skills and be reputed company to manage and prioritize multiple reputed company or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
- Excellent communication (verbal and written) skills required.
- Problem solving skills and ability to reputed company reputed company reputed company based on technical facts and reputed company risk assessments is required.
- reputed company strong reputed company on meeting or exceeding expectations in executing deliverables, performance and results.
- Ability to reputed company and measure performance against defined metrics.
- Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a reputed company of pace and urgency into reputed company.
- Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
- Passionate, reputed company, creative, willing to take prudent risks, and motivated by the creation of a company reputed company on transformative treatments for patients and their families.
- Work Environment: Travel 25%