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Senior Manager Clinical ManagementPosted by: Otsuka
Posted date: Feb-22-2012
Location: Princeton, NJ 08510
Provides leadership and day-to-day guidance to internal and External Service Provider (ESP) study team for all protocols within an assigned program. Ensures cross-study consistency in protocol design, data analysis and reporting. Responsible for the development of clinical protocols concepts to support the company's product strategy. Interacts with expert physicians, investigators, ESP personnel, and functional area staff to ensure program strategy and objectives are understood and implemented and to address program related issues and questions.
• Ensures compliance with FDA and international regulations, GCPs, and SOPs. Develops presentations and reports for Senior Management.
• May supervise Senior Managers, Managers, Clinical Trial Leads, Clinical Oversight Leads, and/or Clinical Project Administrators.
• Acts as the operational lead for a global program (indication, formulation, phase, or other set of related clinical trials), or for multiple clinical programs. Provides guidance to Clinical Trial Leads working within assigned program and ensures operational consistency across assigned clinical trials.
• Serves as a secondary contact for ESP, where Clinical Trial Lead serves as the primary contact.
• Oversees ESP personnel in the development of protocols, amendments, CRFs and other study-related documents. Under the direction of the clinical team, writes protocol outlines, protocols, amendments, and other documents.
• Acts as final reviewer of proposed investigator list for clinical studies
• Communicates and coordinates program-related activities across all relevant cross-functional areas.
• In collaboration with the protocol team, leads the clinical trial data ongoing medical/scientific review focusing on data integrity, trending & consistency across the program. Contribute to final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
• Serves as member of program level teams including GBT/PDC /JDC/Alliance teams and presents to program level updates to senior management and team.
• Oversees ESP and contract personnel implementing program level activities (e.g., PRO development, committee management, regulatory filings etc.)
• Serves as support for global affiliates in relation to regulatory filings, trial implementation, training
• Develops/coordinates short and long-term program level financial estimates (MLTE).
• Coordinates and/or supports program level inspection readiness strategies in preparation for and defense of global regulatory filings and ongoing marketed products.
• Provides clinical research operational expertise in the development of the GCDP, including performing/overseeing and providing background research(literature, SBA, competitive intelligence, regulatory guidance etc).
• Supports ongoing competitive intelligence for program, providing a written or slide summary of findings, as requested.
• Researches validation and methodology for clinical trial endpoints
• Develops program specific standards (e.g., ICF, IB, Slides, trainings, team materials).
• Approves country selection for protocols within assigned program.
• Develops strong scientific partnership with key advisors in assigned therapeutic area.
• Leads program-related advisory boards/committees and meetings.
• Supports the design & implementation of a program level HEOR strategy.
• Participates in marketing and publication strategies and development.
• Provide program training and interactions with MSLs as appropriate.
• Serves as a PORT reviewer for protocols within and across portfolios, as assigned
• Serves as supportive contact for Medical Affairs/PBS related to medical information requests, public disclosure of information (eg, clinicaltrials.gov) and publications strategies.
• Develops and maintains current program level training materials, program slide updates for management.
• Provide/support program level presentations & trainings as required
• Ensures consistency in vendor execution and reporting across related studies.
• Plans program-level risk mitigation strategies.
• Prepares and reviews final study reports.
• Acts as a resource to the study staff to identify problems and propose solutions to maintain projects within designated timelines and budgets.
• Ensures that program activities are conducted following the protocol, ICH, GCP and all applicable global regulatory requirements.
• Acts as Requestor of Service for protocol SOW.
• Approves selection of appropriate study management personnel at ESP.
• Ensures proper oversight of outsourced DMC activities. Organizes/leads program level governance.
• Sets performance expectations for each direct report. Establishes a feedback loop among employee's peers (on departmental and project teams). Provides specific and frequent feedback to the employee on his/her performance. Creates individual development plans.
• If assigned supervisory duties, responsible for training and orienting new employee on corporate culture, corporate expectations and departmental/organizational policies and procedures.
• Works with various groups to devise training program(s) for the employee and makes arrangements for such sessions to be conducted. Ensures the employee has access to all required material, systems to satisfy their individual job responsibilities.
• Assures compliance with departmental, SOP, compliance and corporate training for all direct reports.
• Participates in ESP partnership governance and alliance management activities as assigned, within and across programs and portfolios.
• Represents Clinical Management interests in corporate and cross-affiliate initiatives, as assigned.
• If assigned supervisory duties, assists Senior Director with departmental resourcing and budgeting activities.
• Leads assigned departmental, ESP partner, and corporate standardization and continuous improvement efforts for issues relating to study design and execution.
• Communicates corporate decisions in a timely and effective manner through various venues to ensure staff is aware of updates to corporate culture, vision and management.
• Acts as the operational lead for assigned domestic and global protocol(s)as assigned.
• Supervises contractors, as assigned.
• Performs other duties, as assigned.
• Location: open. The person in this role can be based remotely.
• Comprehensive knowledge of clinical operations, drug development process, roles and responsibilities of individuals within the project team, SOPs and GCP/ICH regulations.
• Thorough knowledge of contract research organizations, outsourcing, and evaluation of work performed against vendor Statement of Work.
• Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate
• 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 (Word, Excel, PowerPoint, Outlook).
• Good understanding of clinical trial related software (eCRFs, IWRS,CTMS).
• Required: Bachelor's degree or registered nurse.
• Minimum of 10 years experience in industry and 7 in clinical trial management.
• Preferred previous supervisory experience.
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Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of Otsuka's ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of its patients around the world with a strong commitment to research and development in the areas of cardiovascular, respiratory, renal and neuroscience systems, and to treat cancer and ophthalmic disorders.