Sr. Manager, Clinical Management, Early Phase: Immunology/Auto-immune

Otsuka Pharmaceutical Co., Ltd.; United States; On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match and retirement benefits

Paid holidays and PTO

Job summary

Otsuka is seeking a Senior Clinical Study Manager to oversee early phase clinical studies (P1-2a) in the United States, coordinating with cross functional teams, ESPs, CROs and internal departments to ensure compliant, on-time trial execution within budget.

You will contribute to study documents, protocol review, budgeting, resourcing, risk mitigation and TMF readiness while guiding the clinical team to maintain data integrity and regulatory compliance across portfolios.

Qualifications

• Oversee complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications.
• Thorough knowledge of CROs, outsourcing, and SOW evaluation.
• Strong understanding of regulatory requirements and clinical program science.
• Experience with Microsoft Office and clinical trial software tools.

Responsibilities

• Provide oversight and management of clinical studies in accordance with regulations and GCP.
• Contribute to development/review of critical study documents (protocols, ICFs).
• Identify and select CROs and ESPs; manage vendor relationships.

Skills

First-in-Human trials knowledge

Vendor & CRO oversight

GCP/ICH regulatory knowledge

Cross-functional leadership

Communication & planning

Microsoft Office suite

Clinical trial software (eCRFs/CTMS/IR

Education

Bachelor's Degree or RN

Tools

MS Office

Clinical trial software (eCRFs/IRT/CTMS)

Job description

Job Summary

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of OtsukaEARLY PHASE (P1-2a) clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget.

Job Description

• Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs.
• Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents.
• Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.
• Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs.
• Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments.
• Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
• Participate in forecasting study expenditures and resourcing needs.
• Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.
• Provide timely communication of any variances in budget forecast to the Director/Associate Director.
• Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.
• Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned.
• Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency.
• Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF.
• Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned.
• Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities.
• Represent Clinical Management in departmental and cross-functional initiatives, as assigned.
• Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.
• Performs other duties, as assigned.

May have supervisory responsibilities

• Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.
• Assuring compliance with departmental, SOP, compliance, and corporate training.
• Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.
• Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.

Qualifications/ Required

Knowledge/ Experience and Skills:

• Ability to oversee complex (ie basket trials) First in Human SAD/MAD/POC trials in immunology/autoimmune indications
• Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).
• Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management.
• Strong understanding of global regulatory requirements.
• Strong communication, organization, planning, analytical, problem solving, and people management skills.
• Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.).
• Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).
• Ability to travel up to 25%.

Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations.

Educational Qualifications

Required:

• Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience.

Preferred:

• Previous supervisory experience.

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.

Salary

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

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.

Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.

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.

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.

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 [e-mail].

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