Kyowa Kirin, Inc.- U.S.
Senior Manager, Clinical Quality Oversight Monitor
Kyowa Kirin, Inc.- U.S., Princeton, New Jersey, us, 08543
Senior Manager, Clinical Quality Oversight Monitor
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Manager, Clinical Quality Oversight is responsible for ensuring the quality and compliance of clinical research activities at Clinical Investigator Sites through the development and execution of oversight monitoring plans. This role may involve conducting both onsite and remote visits to evaluate protocol adherence, data integrity, and the quality of monitoring activities. The Senior Manager may also support clinical trial activities at the protocol, portfolio, and global levels, including oversight of CRO and vendor performance to ensure the effective execution of clinical trials. Additional responsibilities include maintaining accurate operational tracking related to outcomes from Quality Oversight Visits, delivering retraining to CRAs and site staff when necessary, and contributing to audit readiness and support. Essential Functions: Lead the development, authorship, and review of Oversight Monitoring Plans to ensure alignment with clinical research objectives and adherence to regulatory and organizational standards. Conduct both onsite and remote oversight monitoring visits to evaluate protocol compliance, data accuracy, and the quality of monitoring activities, including review of monitoring visit reports and follow-up actions. Implement quality control measures and risk management strategies to proactively identify, assess, and mitigate risks across clinical trials. Prepare detailed oversight monitoring reports summarizing observations, key findings, recommendations, and proposed corrective and preventive actions (CAPAs) for study teams and stakeholders. Provide oversight of CROs and other vendors at the protocol, portfolio, or global level to ensure high-quality execution of clinical trials and to identify opportunities for operational excellence and continuous improvement. Support study management activities related to site monitoring, site relationship management, and coordination of clinical trial operations across assigned protocols, portfolios, or regions. Maintain and update operational tracking systems and local intelligence databases, including accurate contact lists and calendar information, to support effective oversight planning and execution. Provide retraining and guidance to CRAs and site staff, as needed, to reinforce compliance with protocol requirements, GCP, and applicable regulations. Contribute to audit readiness and support quality audits, inspections, and corrective action implementation as required. Requirements: Education
— Bachelor’s degree in a life science, nursing, pharmacy, or closely related healthcare or scientific discipline. Experience
— Minimum of 8 years of progressive experience in clinical research, clinical operations, quality oversight, or related roles within the pharmaceutical, biotechnology, or CRO industry. Strong understanding of global regulatory requirements, including FDA, EMA, and ICH-GCP guidelines; experience with other international regulatory bodies (e.g., PMDA, MHRA, Health Canada) is a plus. Proven experience in oversight of monitoring activities, site management, and CRO/vendor performance, with a focus on quality and compliance. Broad therapeutic area experience preferred; direct experience in oncology and/or rare diseases is highly advantageous. Demonstrated ability to develop and implement risk-based monitoring strategies and quality control processes. Experience preparing for and supporting regulatory inspections and quality audits. Background in mentoring, coaching, and/or training CRAs, site staff, or cross-functional team members preferred. Strong project management skills, with the ability to manage multiple priorities and timelines in a global matrix environment. Strong interpersonal and communication skills, with a proven ability to collaborate effectively across departments and with external partners. Proficient in MS Office Suite. Technical Skills Strong proficiency with clinical trial systems such as CTMS, eCRF, and eTMF. In-depth knowledge of ICH-GCP guidelines, risk-based monitoring (RBM) best practices, risk management, and data management. Ability to assess protocol compliance, data accuracy, and vendor/CRO performance with attention to quality control measures. Working Conditions:
Requires up to 50% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. Compensation and Benefits:
The anticipated salary for this position will be
$155,000 to $170,000 . The actual salary offered may vary based on experience, skill set, qualifications, education, location, and business needs. We offer a comprehensive benefits package including: 401K with company match Discretionary Profit Share Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule including Summer and Winter Shutdowns, Sick Days, and Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs, Vision) Well-Being and Work/Life Programs Life & Disability Insurance Long Term Incentive Program (subject to job level and performance) Pet Insurance Tution Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Compliance & Equal Employment Opportunity:
Kyowa Kirin North America and all employees are obligated to act with integrity and comply with applicable laws. We are an equal employment opportunity employer and do not discriminate on the basis of race, religion, creed, color, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or citizenship status or any other category protected by law.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Manager, Clinical Quality Oversight is responsible for ensuring the quality and compliance of clinical research activities at Clinical Investigator Sites through the development and execution of oversight monitoring plans. This role may involve conducting both onsite and remote visits to evaluate protocol adherence, data integrity, and the quality of monitoring activities. The Senior Manager may also support clinical trial activities at the protocol, portfolio, and global levels, including oversight of CRO and vendor performance to ensure the effective execution of clinical trials. Additional responsibilities include maintaining accurate operational tracking related to outcomes from Quality Oversight Visits, delivering retraining to CRAs and site staff when necessary, and contributing to audit readiness and support. Essential Functions: Lead the development, authorship, and review of Oversight Monitoring Plans to ensure alignment with clinical research objectives and adherence to regulatory and organizational standards. Conduct both onsite and remote oversight monitoring visits to evaluate protocol compliance, data accuracy, and the quality of monitoring activities, including review of monitoring visit reports and follow-up actions. Implement quality control measures and risk management strategies to proactively identify, assess, and mitigate risks across clinical trials. Prepare detailed oversight monitoring reports summarizing observations, key findings, recommendations, and proposed corrective and preventive actions (CAPAs) for study teams and stakeholders. Provide oversight of CROs and other vendors at the protocol, portfolio, or global level to ensure high-quality execution of clinical trials and to identify opportunities for operational excellence and continuous improvement. Support study management activities related to site monitoring, site relationship management, and coordination of clinical trial operations across assigned protocols, portfolios, or regions. Maintain and update operational tracking systems and local intelligence databases, including accurate contact lists and calendar information, to support effective oversight planning and execution. Provide retraining and guidance to CRAs and site staff, as needed, to reinforce compliance with protocol requirements, GCP, and applicable regulations. Contribute to audit readiness and support quality audits, inspections, and corrective action implementation as required. Requirements: Education
— Bachelor’s degree in a life science, nursing, pharmacy, or closely related healthcare or scientific discipline. Experience
— Minimum of 8 years of progressive experience in clinical research, clinical operations, quality oversight, or related roles within the pharmaceutical, biotechnology, or CRO industry. Strong understanding of global regulatory requirements, including FDA, EMA, and ICH-GCP guidelines; experience with other international regulatory bodies (e.g., PMDA, MHRA, Health Canada) is a plus. Proven experience in oversight of monitoring activities, site management, and CRO/vendor performance, with a focus on quality and compliance. Broad therapeutic area experience preferred; direct experience in oncology and/or rare diseases is highly advantageous. Demonstrated ability to develop and implement risk-based monitoring strategies and quality control processes. Experience preparing for and supporting regulatory inspections and quality audits. Background in mentoring, coaching, and/or training CRAs, site staff, or cross-functional team members preferred. Strong project management skills, with the ability to manage multiple priorities and timelines in a global matrix environment. Strong interpersonal and communication skills, with a proven ability to collaborate effectively across departments and with external partners. Proficient in MS Office Suite. Technical Skills Strong proficiency with clinical trial systems such as CTMS, eCRF, and eTMF. In-depth knowledge of ICH-GCP guidelines, risk-based monitoring (RBM) best practices, risk management, and data management. Ability to assess protocol compliance, data accuracy, and vendor/CRO performance with attention to quality control measures. Working Conditions:
Requires up to 50% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. Compensation and Benefits:
The anticipated salary for this position will be
$155,000 to $170,000 . The actual salary offered may vary based on experience, skill set, qualifications, education, location, and business needs. We offer a comprehensive benefits package including: 401K with company match Discretionary Profit Share Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule including Summer and Winter Shutdowns, Sick Days, and Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs, Vision) Well-Being and Work/Life Programs Life & Disability Insurance Long Term Incentive Program (subject to job level and performance) Pet Insurance Tution Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Compliance & Equal Employment Opportunity:
Kyowa Kirin North America and all employees are obligated to act with integrity and comply with applicable laws. We are an equal employment opportunity employer and do not discriminate on the basis of race, religion, creed, color, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or citizenship status or any other category protected by law.
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