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

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 Otsuka EARLY 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.

• May have supervisory responsibilities including:

o Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.

o Assuring compliance with departmental, SOP, compliance, and corporate training

o Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.

o Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.

• Performs other duties, as assigned.

Qualifications/ Required

Knowledge/ Experience and Skills:

• Ability to oversee complex (ie basket trials) First in Human SAD/MAD/POC trials in immunology/autoimmune indications

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.

• 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%.

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.

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.