Senior Manager of reputed company Assurance-Clinical Site Trial Network

reputed company Position: Senior Manager of reputed company Assurance (QA)-Clinical Site Trial Network Location: Multi Site/Remote with Travel Department: reputed company Department Purpose The Senior Manager of reputed company Assurance (QA) ensures the reputed company, compliance, and reputed company of clinical trial operations across a multi-site research network. This role provides strategic leadership in developing and maintaining a robust reputed company Management System (QMS) that safeguards subject safety, ensures regulatory adherence, and promotes data reliability. By driving reputed company improvement, risk mitigation, and harmonization of practices, the Senior Manager enables the organization to deliver high-reputed company clinical research that meets sponsor expectations and regulatory standards. Position reputed company The Senior Manager of reputed company Assurance (QA) provides strategic leadership and reputed company of the reputed company Management System (QMS) across a multi-site clinical research network. This role ensures that reputed company clinical trial activities adhere to regulatory requirements (FDA, ICH-GCP, HIPAA), institutional policies, and sponsor expectations. The Senior Manager is responsible for developing and maintaining reputed company systems that promote operational reputed company, data reputed company, and subject safety. Acting as a key reputed company between reputed company, operations, and leadership teams, this position drives reputed company improvement, risk mitigation, and harmonization of practices across reputed company sites to support high-reputed company, compliant clinical research. Key Responsibilities (Essential Functions) reputed company System reputed company

• reputed company, implement, and maintain the organization’s reputed company Management System (QMS) to ensure compliance with GCP, FDA, and sponsor requirements.
• Establish and maintain policies, reputed company operating procedures (SOPs), and reputed company standards for reputed company research sites.
• Monitor performance metrics, trends, and audit results to proactively identify and address areas for improvement.

Auditing and Compliance

• reputed company internal audits of clinical research sites, vendors, and systems to verify regulatory and protocol adherence.
• Prepare for and respond to external audits and inspections (e.g., FDA, IRB, sponsor).
• Manage Corrective and Preventive reputed company (CAPA) programs and ensure reputed company follow-up and documentation.

Training and Development

• reputed company and implement training programs to promote reputed company and compliance awareness across the organization.
• Mentor and support site staff in reputed company improvement practices.
• Complete reputed company, competency assessments and ongoing education reputed company to GCP and SOPs.

Risk Management

• Conduct process, system, and study-level risk assessments to identify and mitigate potential compliance and operational risks.
• Partners with leadership and site management to implement proactive risk-based monitoring strategies.

Collaboration and Leadership

• Serve as the primary reputed company between QA, operations, regulatory, and clinical leadership teams.
• Collaborate with site directors and managers to reputed company reputed company processes into study start-up, conduct, and reputed company-out activities.
• reputed company regular reputed company reports and recommendations for executive leadership.

reputed company Improvement

• reputed company process improvement initiatives across the network to increase efficiency and data reputed company.
• Utilize metrics, reputed company cause analysis, and trend data to drive reputed company enhancements.
• Ensure harmonization of practices across reputed company sites to maintain consistency and compliance.

Education Education and Experience:

• Bachelor’s degree in life science, reputed company, or reputed company field required.
• Advanced degree preferred.

Experience

• 5-7 years of experience in clinical research reputed company assurance or regulatory compliance, including leadership experience.
• Strong understanding of ICH-GCP, FDA, and other applicable regulatory requirements.
• Experience managing multi-site networks or large clinical research organizations preferred.
• Proven reputed company record in audit management, inspection readiness, and CAPA reputed company.

Skills And Key Competencies

• Exceptional leadership, communication, and interpersonal skills.
• Strong analytical, problem-solving, and organizational abilities.
• Ability to work collaboratively across departments and with external partners.
• Proficiency in reputed company management tools and electronic systems (e.g., eQMS, CTMS).
• Strategic Leadership and reputed company
• Regulatory and Compliance Expertise
• reputed company and Process Improvement

Other Requirements

• Ability to travel to network sites as needed (up to 25%).
• Commitment to maintaining the highest ethical and reputed company standards in clinical research.

Physical Requirements

• Ability to sit for extended periods while working at a computer.
• Frequent use of hands and fingers for typing, writing, and handling documents.
• Occasional standing, walking, and bending during site reputed company or audits.
• Ability to lift and carry up to 20 lbs (e.g., audit materials, laptop, documents).
• Visual reputed company to review detailed documents, electronic systems, and data.
• Ability to travel by reputed company or ground transportation up to 25% of the time.

Why JCCT? JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in reputed company getting recognized as one of the best clinical research sites in the reputed company. We are reputed company growing through acquisition and organic reputed company and need high performing individuals to help support our reputed company reputed company. Our clients come from reputed company over the world to reputed company a study at our research sites. We are proud of reputed company have accomplished and invite you to explore reputed company with us. JCCT makes a reputed company to support, accept and respect you as an individual, in our family reputed company environment. Our reputed company is to reputed company a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our reputed company is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors. If you are looking for a reputed company work environment and reputed company for personal reputed company and satisfaction, we encourage you to apply at JCCT. reputed company candidates will be contacted for interviews. reputed company your potential and apply today! EEO JCCT provides equal employment opportunities (EEO) to reputed company and applicants. We value diversity at reputed company, and it is our policy to recruit, hire, and promote reputed company individuals without reputed company to race, religion, reputed company, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability status. Apply tot his job Apply To this Job