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 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 involves conducting both onsite and remote visits to evaluate protocol adherence data integrity and the quality of monitoring activities. The Senior Manager may also supports 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 re-training 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 the 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 re-training 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
Bachelors 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.

The anticipated salary for this position will be $155000 to $170000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications job-based knowledge location and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Discretionary Profit Share
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition 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.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America Inc. to provide equal employment opportunity to all qualified persons without regard to race religion creed color pregnancy sex age national origin disability genetic trait or predisposition veteran status marital status sexual orientation or affection preference or citizenship status or any other category protected by law.

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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