The Senior Manager, Clinical Compliance is responsible for the planning, development, implementation of clinical operations systems, processes and process improvement initiatives. Clinical systems includes, but is not limited to, paper TMF, eTMF, CTMS. Responsible for oversight of clinical compliance with relevant regulatory, internal standard operating procedures and industry standards.
- Responsible for implementation and management of daily systems operations and support of key Clinical systems. Systems include but not limited to eTMF, paper TMF, and CTMS.
- Leads the management Clinical Study Records life cycle, including retention and disposition of records and associated audit trails in accordance with best business practices and corporate policies and procedures
- Responsible for managing the operations of the portfolio of Clinical Systems to ensure compliance with regulations and operational effectiveness.
- Responsible for creation and executing clinical systems training
- Responsible to ensure systems and operations are in compliance with all internal and regulatory requirements
- Supports Clinical Compliance in providing measures of performance such as Metrics and KPI for continuous improvement
- Supports Clinical Operations by providing risk-based assessments for Jazz Clinical Trials as defined by ICH E6 (R2)
- Collaborates with Clinical Operations members on a regular basis ensuring user expectations are met in providing day to day support
- Establishes streamlined support process in partnership with IT and QA
- Collaborates with Clinical Quality Assurance to support process improvement
- Stays abreast of corporate policies and infrastructure improvements
- Contributes to strategic vision and direction of the systems under management and helps to manage the delivery of strategic objectives
- Oversees the archival, tracking and retrieval processes for completed TMFs stored on or off site
- Oversees the integrity of TMF storage area (room access, closure, etc.)
- Lead the Systems and Clinical document control efforts in preparing for an participating in an audit and/or regulatory inspection
- Supports internal and external audit including development and implementation of CAPA results activities and
- Provides compliance support for Notice of Events for all functional areas
- Manages the transition of proprietary information for acquisitions, divestitures and licensing of compounds related to the trail master file records
- Experience with regulatory inspections
- Must have management experience
Required Knowledge, Skills, and Abilities
- Advanced experience in Trial Master File requirements and set up
- Knowledge of DIA filing structure
- A successful track record driving the development and deployment of clinical trial technologies at the enterprise level
- A firm understanding of the clinical development lifecycle and the technologies associated with the activation and management of clinical trials and study sites
- Experience in leading requirements gathering, business process and change management for a major technology deployment within the clinical development area
- Strong understanding of study and site management and overall trial planning and execution
- Strong knowledge of global regulatory requirements and ICH/GCP guidelines
- Strong Working knowledge with electronic document management systems, document archival systems (eTMF) and CTMS system
- Demonstrated ability to work independently and in a team environment
- Strong organizational abilities, action oriented and strong communication skills
- Able to carry out responsibilities with minimal to no supervision
Required/Preferred Education and Licenses
- Master’s/Bachelor’s degree preferred, RN or equivalent industry experience
- A minimum of 10 or more years’ experience in the Pharmaceutical Industry with at least 5 years direct experience in Clinical Trials, TMF and clinical systems and processes, and compliance
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, Visio)
Description of Physical Demands
- Occasional mobility within office environment.
- Occasional travel required-approximately 10% (quarterly)
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.