- 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. 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. May supervise Managers, Clinical Trial Leads, Clinical Oversight Leads and/or Clinical Project Administrators.
- Acts as the operational lead for a program (indication, formulation, phase, or other related clinical trials). 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.
- Develops protocol outlines, protocols, amendments, and CRF standards
- Reviews clinical trial data, focusing on data integrity, trending & consistency across the program.
- Contributes to the review, analysis and interpretation of data including the development of clinical study reports, publications and internal/external presentations.
- Serves as support for global affiliates in relation to regulatory filings, trial implementation and training
- Contributes to the development of program level financial estimates (eg, MLTE).
- Contribute to the preparation and defense of clinical program documents (eg. Investigator Brochure, responses to Health Authority questions, regulatory submissions).
- Supports program level inspection readiness strategies.
- 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
- Provides program-level reporting to management.
- Approves country selection for protocols within assigned program. Acts as final reviewer of proposed investigator list for clinical studies
- Plans program-level risk mitigation strategies. 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.
- Oversees outsourced program committee activities.
- If assigned supervisory duties:
- Responsible for training and orienting new employee(s) 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.
- 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.
- Assures compliance with departmental, SOP, compliance and corporate training for all direct reports.
- Assists Senior Director with departmental resourcing and budgeting activities.
- Communicates corporate decisions in a timely and effective manner through various venues to ensure staff are aware of updates to corporate culture, vision and management.
- Participates in CROpartnership 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.
- Leads and/or contributes to assigned departmental, CRO partner, and corporate standardization and continuous improvement efforts for issues relating to study design and execution.
- Supervises contractors, as assigned.
- Other duties, as assigned.
Knowledge: Comprehensive knowledge of the drug development process, roles and responsibilities of individuals within the project team, SOPs and GCP/ICH regulations, 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 that knowledge in operational management. Understanding of global regulatory requirements.
Skills: 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 7 years industry experience with 5 years experience in clinical trial management.
Preferred:Bachelor’s degree in a health science field
Travel: Approximately 25%
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of maental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.