CenExel
Quality Assurance Manager (Clinical Research) – CenExel
Join to apply for the
Quality Assurance Manager (Clinical Research)
role at CenExel. Overview
CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long‑standing research facilities in the country. Specialty areas across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each center has tremendous experience and expertise in complex early phase trials, and all sites have in‑patient capability. CenExel focuses on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work‑life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Insurance, and 401k. Job Summary
Responsible for the supervision, maintenance, and support of Quality Assurance functions per the Quality Management Standard Operating Procedure (SOP) and site Clinical Quality Management Plan (CQMP). Oversight of daily operations of the quality department, ensuring the highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. Compensation : $95,000-105,000/year. Responsibilities and Duties
Manages Quality Assurance Department and is responsible for all Quality Assurance staff. Develops, implements and follows up on quality assurance programs including necessary or appropriate policies and guidelines. Conducts periodic audits of clinical research data, facilities, and processes. Communicates findings, opportunities, improvements, and training needs to site leadership and Regional Quality Assurance Manager. Oversees Risk Management Plans and collaborates with senior leadership and research teams to identify and mitigate risks for all clinical studies. Oversees queries and manages proper query resolution within the contracted timeframe. Evaluates protocol deviation metrics and implements process improvement and staff training, where necessary. Assists in developing Corrective and Preventative Action (CAPA) Plans, including evaluation of effectiveness. Divides workload among Quality Assurance staff. Manages employee discipline, if required. Reviews all documents necessary to implement the study including, but not limited to, telephone screening questionnaire, visit source documents and logs. Reviews regulatory documents for completion and accuracy as assigned. Assist with sponsor audits and FDA inspections as assigned. Prepares audit and inspection observation responses, as assigned. Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA CFR, ICH, GCP, CenExel SOPs, site WPs, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned and are not all inclusive. Education/Experience/Skills
Must be able to effectively communicate verbally and in writing. Must be a high school graduate or have GED equivalency. Minimum 4 years of Quality Assurance experience. Must have the ability to perform detail‑oriented work and follow up on assignments. Accuracy, thoroughness and attention to detail imperative. Must be self‑motivated and able to perform tasks independently. Ability to set clear goals and articulate a vision for the team, defining priorities and aligning them with organizational objectives. Motivating team members by providing encouragement and creating a positive and productive work culture. Making sound, timely decisions, even in situations with incomplete information or under pressure. Ability to communicate goals, expectations, feedback, and concerns clearly to the team. Understanding the needs and ideas of team members by listening attentively. Effectively managing and resolving conflicts by encouraging open dialogue and finding mutually agreeable solutions. Tailoring communication style to suit different individuals and situations (e.g., one‑on‑one meetings, team briefings, or presentations). Assigning the right tasks to the right people based on their skills and development goals. Managing time effectively by prioritizing high‑impact activities. Identifying problems, analyzing data, and determining solutions based on logical reasoning and facts. Assessing risks and making decisions that minimize negative impacts while seizing opportunities for growth. Giving constructive feedback regularly to help team members improve and grow. Providing guidance to junior staff to foster skill development and career advancement. Identifying skill gaps and facilitating learning opportunities for the team. Supporting the team through transitions by managing resistance, maintaining morale, and ensuring new processes are effectively implemented. Addressing conflicts directly and impartially, ensuring issues are resolved in a way that benefits the team and organization. Managing emotions and maintaining professionalism in stressful situations. Understanding one’s own emotions, strengths, and weaknesses and how they impact others. Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance. Must clearly communicate through written and verbal means with sponsors and staff. Working Conditions
Indoor, Clinic and Office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On site work arrangement. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
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Join to apply for the
Quality Assurance Manager (Clinical Research)
role at CenExel. Overview
CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long‑standing research facilities in the country. Specialty areas across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each center has tremendous experience and expertise in complex early phase trials, and all sites have in‑patient capability. CenExel focuses on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work‑life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Insurance, and 401k. Job Summary
Responsible for the supervision, maintenance, and support of Quality Assurance functions per the Quality Management Standard Operating Procedure (SOP) and site Clinical Quality Management Plan (CQMP). Oversight of daily operations of the quality department, ensuring the highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. Compensation : $95,000-105,000/year. Responsibilities and Duties
Manages Quality Assurance Department and is responsible for all Quality Assurance staff. Develops, implements and follows up on quality assurance programs including necessary or appropriate policies and guidelines. Conducts periodic audits of clinical research data, facilities, and processes. Communicates findings, opportunities, improvements, and training needs to site leadership and Regional Quality Assurance Manager. Oversees Risk Management Plans and collaborates with senior leadership and research teams to identify and mitigate risks for all clinical studies. Oversees queries and manages proper query resolution within the contracted timeframe. Evaluates protocol deviation metrics and implements process improvement and staff training, where necessary. Assists in developing Corrective and Preventative Action (CAPA) Plans, including evaluation of effectiveness. Divides workload among Quality Assurance staff. Manages employee discipline, if required. Reviews all documents necessary to implement the study including, but not limited to, telephone screening questionnaire, visit source documents and logs. Reviews regulatory documents for completion and accuracy as assigned. Assist with sponsor audits and FDA inspections as assigned. Prepares audit and inspection observation responses, as assigned. Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA CFR, ICH, GCP, CenExel SOPs, site WPs, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned and are not all inclusive. Education/Experience/Skills
Must be able to effectively communicate verbally and in writing. Must be a high school graduate or have GED equivalency. Minimum 4 years of Quality Assurance experience. Must have the ability to perform detail‑oriented work and follow up on assignments. Accuracy, thoroughness and attention to detail imperative. Must be self‑motivated and able to perform tasks independently. Ability to set clear goals and articulate a vision for the team, defining priorities and aligning them with organizational objectives. Motivating team members by providing encouragement and creating a positive and productive work culture. Making sound, timely decisions, even in situations with incomplete information or under pressure. Ability to communicate goals, expectations, feedback, and concerns clearly to the team. Understanding the needs and ideas of team members by listening attentively. Effectively managing and resolving conflicts by encouraging open dialogue and finding mutually agreeable solutions. Tailoring communication style to suit different individuals and situations (e.g., one‑on‑one meetings, team briefings, or presentations). Assigning the right tasks to the right people based on their skills and development goals. Managing time effectively by prioritizing high‑impact activities. Identifying problems, analyzing data, and determining solutions based on logical reasoning and facts. Assessing risks and making decisions that minimize negative impacts while seizing opportunities for growth. Giving constructive feedback regularly to help team members improve and grow. Providing guidance to junior staff to foster skill development and career advancement. Identifying skill gaps and facilitating learning opportunities for the team. Supporting the team through transitions by managing resistance, maintaining morale, and ensuring new processes are effectively implemented. Addressing conflicts directly and impartially, ensuring issues are resolved in a way that benefits the team and organization. Managing emotions and maintaining professionalism in stressful situations. Understanding one’s own emotions, strengths, and weaknesses and how they impact others. Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance. Must clearly communicate through written and verbal means with sponsors and staff. Working Conditions
Indoor, Clinic and Office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On site work arrangement. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
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