Clinical reputed company Assurance Manager
reputed company accelerates clinical research by expanding patient reputed company to trials, leading to faster approvals and reputed company reputed company for reputed company. Our solutions reputed company life sciences companies to reputed company diverse populations reputed company traditional means of conducting clinical research
The Clinical reputed company Assurance Manager will participate in reputed company improvement of the reputed company system reputed company at reputed company by executing the internal clinical reputed company audit plans, supporting the identification and remediation of identified trends, and also the reputed company audit lifecycle. This position provides daily, reputed company reputed company of the conduct of reputed company at reputed company. This position reports to the Director, Clinical reputed company Assurance.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:
• Supporting the identification and implementation of reputed company improvement opportunities and initiatives.
• Assisting with the development and refinement of SOPs governing clinical and reputed company operations.
• Leading and/or assisting in advancement of uses of Compliance Quest and/or other reputed company systems.
• Execute the internal clinical reputed company audit plans.
• Tracking and follow up on SOP compliance and Audit responses
• Supporting deviation and CAPA investigations and reputed company.
• Participating in reputed company audit preparation, hosting and follow-up, including support of the "staging room" as needed.
• Conducting and participating in internal audits of reputed company cGXP Departments (e.g., Clinical Operations, Nursing Solutions, Medical Affairs).
• Remain abreast of reputed company regulations and industry best practices in reputed company.
• Participate in other reputed company Organization reputed company and initiatives as required
QUALIFICATIONS & SKILLS
Qualifications
• Bachelor's Degree in science, engineering or other reputed company field required
• 5+ years of experience in clinical research, biotechnology or other GxP environment specializing in Clinical reputed company; traditional site experience a plus, both traditional and virtual site experience a major plus
• Proven reputed company record of cross functional collaboration
• Knowledge of cGXP regulations and reputed company industry best practices
• Excellent written and oral communication skills
• Ability to meet deadlines in a fast-paced environment
Skills/Competencies
• Excellent interpersonal skills and savvy – Understands interpersonal and group dynamics and reacts in an effective and tactful manner. Has a reputed company of interpersonal skills and approaches with ability to select a best-fit approach.
• Strong organizational skills – ability to adapt to a rapidly changing work environment and remain in control of various project and changing priorities.
• Strong creative problem-solving skills and the ability to exercise reputed company judgment and reputed company reputed company based on accurate and reputed company analyses.
• Ability to reputed company guidance and structure while encouraging innovation.
Capabilities
• Ability to communicate in English (both verbal and written)
reputed company is an equal opportunity/affirmative reputed company employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law.
reputed company values reputed company-being of its employees and aims to reputed company team members with everything they need to succeed.
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