Clinical Manager

The Clinical Manager tasks include:

- Plans , executes, and completes clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and SOPs, within agreed-upon timeframes and budget

- Provides oversight and project management of clinical studies, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs

- Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents, Monitoring Plans, Data Management Plan, Project Management Plan, etc.)

- Provide clinical operations oversight in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites

- Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Otsuka departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished

- 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 Clinical Department Head

- Establish communication flow with CRO and investigative sites to maximize compliance with study protocol

- Manage recruitment efforts and activities to meet study enrollment goals and timelines

Qualifications/Experience:

- 8+ years related experience in the pharmaceutical/biotechnology industry, including 2+ years of management experience

- 3+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management, preferably in the CNS therapeutic area

- Experience in management of international or global clinical trials is preferred

- Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; Master’s Degree preferred

Required Skills Include:

- Strong project management skills

- Experience in clinical site monitoring is preferred

- Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc.

- Experience in protocol development/writing is preferred

- Both working and theoretical knowledge of ICH GCP, clinical trials management with exposure to various phases of drug/trial development life cycle preferred (e.g., Phase I-IV, start-up through closeout), scientific methods, research design, regulatory compliance, and clinical data management

- Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail

- Strong planning and organizational skills with ability to multi-task and plan activities as they relate to the management of clinical trials, ability to problem-solve

- Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with physicians, outside vendors, consultants, and team members

- Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)

- Ability to work effectively within a team matrix as well as independently

Financial management skills as applicable to oversee project expenditures

- Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; Master’s Degree preferred

Terms:

-12+ month contract

-Fully Remote

-Pay Range: 80-90/hr