Senior Manager, Clinical Management

About the role

The Senior Clinical Study Manager oversees and manages Otsuka clinical studies, coordinating with various parties to ensure trials are conducted according to regulations and guidelines.

Responsibilities

• Planner, executor, and finisher of clinical trials according to applicable regulations and guidance, ICH/GCP, and Otsuka SOPs.
• Development and review of critical clinical study documents, including clinical protocols, informed consent forms, and other study-related documents.
• Identification, evaluation, and selection of CROs, vendors, and investigative sites.
• Leadership and guidance of the clinical team to ensure compliance with regulations and guidelines.
• Communication and coordination of clinical project activities across relevant departments.
• Forecasting study expenditures and managing resources.
• Ensuring budget management and monitoring by internal teams and vendors.
• Establishing communication with CROs and investigative sites for compliance with study protocols.
• Overseeing ESPs in their daily operations.
• Ongoing review of clinical trial data for data integrity, trends, and consistency.
• Participation in project and program-level inspection readiness activities.
• Representing Clinical Management in departmental and cross-functional initiatives.
• Leading and contributing to departmental, ESP, and corporate standardization and continuous improvement efforts.
• Training and onboarding of new employees.
• Ensuring compliance with departmental, SOP, compliance, and corporate training.
• Setting clear performance expectations and individual development plans for staff.

Qualifications/Required Knowledge/Experience and Skills

• 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%.

Qualifications

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

Pay

$150,034.00 - $224,250.00, plus incentive opportunity.

Schedule

Not specified.

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.