Jazz Pharmaceuticals, Inc. Sr. Manager, Clinical Compliance in Palo Alto, California
Sr. Manager, Clinical Compliance
Palo Alto, California
Responsible for the planning, development, implementation of clinical operations systems, processes and process improvement initiatives. Clinical systems will include but not limited to paper TMF, eTMF, CTMS. Responsible to ensure 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, CTMS.
Leads the management of 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 Clincial Compliance in providing measures of performance such as Metrics and KPI for continuous improvement
Collaborates with Clinical Operations members on regular basis ensuring user expectations are met in providing day to day support
Establishes streamlined support process in partnership with IT and QA
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 the strategic objectives
Manage the archival, tracking and retrieval processes for completed TMFs stored on or off site.
Maintain integrity of TMF storage area (room access, closure, etc.) and orchestrate off-site storage processes
Lead the Systems and Clinical document control efforts in preparing for and participating in an audit and/or regulatory inspection.
Support internal and external audit including development and implementation of CAPA results activities
Manages the transition of proprietary information for acquisitions, divestitures and licensing of compounds related to trial 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 communciation skills
Able to carry out responsibilities with minimal to no supervision
Required/Preferred Education and Licenses
- Master’s degree & a minimum of 4 years of directly related experience, OR
Bachelor’s degree & a minimum of 6 years directly related experience
A minimum of 7 or more years’ experience in the Pharmaceutical Industry with at least 5 years direct experience in Clinical Trials, TMF and clinical systems and process
Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
Description of Physical Demands
Occasional mobility within office environment.
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, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.