Otsuka Pharmaceutical Co.
Manager, Clinical Operations, Monitoring Oversight
Otsuka Pharmaceutical Co., Myrtle Point, Oregon, United States, 97458
Job Summary
The Manager, Clinical Operations works closely with the OPDC Monitoring Oversight Lead to manage monitoring oversight activities including managing Clinical Monitoring Consultants (CMC) contracted to perform monitoring oversight duties as well as escalating issues related to CRO monitoring quality. While focusing on quality and compliance, uses metrics and key performance indicators to drive monitoring oversight activities to achieve timelines and deliverables across the portfolio. Additionally, the Manager, Clinical Operations will support planning, resourcing, contracting, and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager, Clinical Operations will also coordinate reporting and review of CRO related Key Performance Indicators (KPIs) Monitoring Oversight Lead.
Responsibilities
Manage Monitoring Oversight activities in North America, and other regions as assigned
With the OPDC Monitoring Oversight Lead, plan conduct of Oversight Accompanied Visits (OAV) in the assigned region(s)
Manage, onboard, train and evaluate CMC resources to perform monitoring oversight tasks
Ensure adherence to training requirements for assigned CMCs (SOPs and study specific training)
Report status and output of OAVs and other monitoring oversight activities to OPDC Oversight Lead
Review OAV reports and manage timelines and deliverables
Oversee FSP monitoring resources in assigned region(s) as applicable
Support implementation and improvement of monitoring oversight related processes
Ensure compliance with Otsuka policies and procedures and applicable Key Performance Indicators (KPIs)
Provide oversight of required metrics across all monitoring oversight service providers and contribute to monthly reporting of monitoring oversight related KPIs to CM&O Management
Conduct Assessment Visits of CMCs to assess quality and compliance with applicable policies and procedures per the monitoring oversight job aids
Escalate significant issues related to oversight visits (e.g., site, study, CRA, etc.) in a timely manner to the Monitoring Oversight Lead, Clinical Operations management, and Study Management as applicable
Ensure compliance with clinical systems use and updates
Provide support for internal audit and regulatory inspection activities as applicable
Review study specific monitoring plans and provide feedback prior to implementation
Collaborate with CMC staffing vendors, as applicable
Manage consultant CMC contracts, budgets, and expenses to meet forecasts and support the development of annual regional monitoring oversight budget
Other monitoring oversight activities as assigned by OPDC Oversight Lead
Qualifications / Required
Experience managing field-based Clinical Research Associates
Demonstrated ability to lead teams
Proficient with on-site monitoring activities (Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit)
Demonstrated strengths with critical thinking and analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
Ability to supervise, direct and lead team members as well as interact with other internal staff and external vendors
Strong planning and organization skills with the ability to multi-task and plan activities are they relate to field monitoring operations
Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance
Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants
Possess advanced computer skills (e.g., Microsoft applications)
Financial management skills as applicable to oversee initiatives and system expenditures
Ability to handle and prioritize multiple tasks
Ability to work effectively in a team/matrix environment
Ability to travel up to 30% including ground and air travel
7 years of industry experience and a minimum BA/BS Life Sciences, or equivalent college program, is required
Competencies
Accountability for Results – Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change
Strategic Thinking & Problem Solving – Make decisions considering the long-term impact to customers, patients, employees, and the business
Patient & Customer Centricity – Maintain an ongoing focus on the needs of our customers and/or key stakeholders
Impactful Communication – Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka
Respectful Collaboration – Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals
Empowered Development – Play an active role in professional development as a business imperative
Compensation Minimum $107,718.00 – Maximum $161,000.00, plus incentive opportunity. The range shown represents a typical pay range for individuals hired in the role in the United States.
Application Deadline This will be posted for a minimum of 5 business days.
Company Benefits Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Benefits Information Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Equal Opportunity Employer Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
Disability Accommodation If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
#J-18808-Ljbffr
Responsibilities
Manage Monitoring Oversight activities in North America, and other regions as assigned
With the OPDC Monitoring Oversight Lead, plan conduct of Oversight Accompanied Visits (OAV) in the assigned region(s)
Manage, onboard, train and evaluate CMC resources to perform monitoring oversight tasks
Ensure adherence to training requirements for assigned CMCs (SOPs and study specific training)
Report status and output of OAVs and other monitoring oversight activities to OPDC Oversight Lead
Review OAV reports and manage timelines and deliverables
Oversee FSP monitoring resources in assigned region(s) as applicable
Support implementation and improvement of monitoring oversight related processes
Ensure compliance with Otsuka policies and procedures and applicable Key Performance Indicators (KPIs)
Provide oversight of required metrics across all monitoring oversight service providers and contribute to monthly reporting of monitoring oversight related KPIs to CM&O Management
Conduct Assessment Visits of CMCs to assess quality and compliance with applicable policies and procedures per the monitoring oversight job aids
Escalate significant issues related to oversight visits (e.g., site, study, CRA, etc.) in a timely manner to the Monitoring Oversight Lead, Clinical Operations management, and Study Management as applicable
Ensure compliance with clinical systems use and updates
Provide support for internal audit and regulatory inspection activities as applicable
Review study specific monitoring plans and provide feedback prior to implementation
Collaborate with CMC staffing vendors, as applicable
Manage consultant CMC contracts, budgets, and expenses to meet forecasts and support the development of annual regional monitoring oversight budget
Other monitoring oversight activities as assigned by OPDC Oversight Lead
Qualifications / Required
Experience managing field-based Clinical Research Associates
Demonstrated ability to lead teams
Proficient with on-site monitoring activities (Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit)
Demonstrated strengths with critical thinking and analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
Ability to supervise, direct and lead team members as well as interact with other internal staff and external vendors
Strong planning and organization skills with the ability to multi-task and plan activities are they relate to field monitoring operations
Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance
Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants
Possess advanced computer skills (e.g., Microsoft applications)
Financial management skills as applicable to oversee initiatives and system expenditures
Ability to handle and prioritize multiple tasks
Ability to work effectively in a team/matrix environment
Ability to travel up to 30% including ground and air travel
7 years of industry experience and a minimum BA/BS Life Sciences, or equivalent college program, is required
Competencies
Accountability for Results – Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change
Strategic Thinking & Problem Solving – Make decisions considering the long-term impact to customers, patients, employees, and the business
Patient & Customer Centricity – Maintain an ongoing focus on the needs of our customers and/or key stakeholders
Impactful Communication – Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka
Respectful Collaboration – Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals
Empowered Development – Play an active role in professional development as a business imperative
Compensation Minimum $107,718.00 – Maximum $161,000.00, plus incentive opportunity. The range shown represents a typical pay range for individuals hired in the role in the United States.
Application Deadline This will be posted for a minimum of 5 business days.
Company Benefits Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Benefits Information Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Equal Opportunity Employer Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
Disability Accommodation If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
#J-18808-Ljbffr