ROLE SUMMARY

　　As part of the Clinical Data Science (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Training Manager is responsible for ensuring that training content is developed that balances the required process elements as well as the role based training elements. This role is the primary deliverer of live learning opportunities as well as ensuring the alignment with Pfizer training materials and programs.

　　ROLE RESPONSIBILITIES

　　Develops, maintains, schedules and delivers role based training programs to Clinical Data Science (CDS) rolesIncorporates techniques of "accelerated learning" in the development and/or delivery of trainingSets learning goals in alignment with department and Pfizer goalsSets learning targets for CDS roles that ensures a focus on both current Data Monitoring and Management practices and those that are evolving into Industry best practicesDevelops specific training materials to support CDS stakeholders group knowledgeDevelops assessment tools intended to ensure process and technical knowledge is sufficientMaintains the CDS role training curriculums and acts as the CDS Point of Contact for developing educational materials within the larger Pfizer learning networkEnsures that leading edge learning techniques are in place to support learning within the departmentSupports communication activities within department designed to educate and build awareness within and outside of department related to data monitoring and management topicsManage for the compliance of training and qualification (including CV, JD and Org. Charts), Activity Tracker etc. at departmental level. CV - curriculum vitae: yearly review and information change. JD - job description: review and create for new job roleSupport for the quality management implementation

　　QUALIFICATIONS & EXPERIENCE:

　　• Bachelor's degree required. Preference for degree in scientific field at a Master's level.

　　• Minimum 10 years Data Management experience required including 5+ years in a training development role

　　• Demonstrated knowledge of clinical research processes and regulatory requirements.

　　• Thorough understanding of systems and requirements as defined by regulatory agencies and Pfizer processes, SOPs and Data Standards. Knowledge of ICH GCP and regulation

　　• Demonstrated successful experience in all relevant data management activities in a BioPharma or CRO setting

　　• Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review

　　• Experience using commercial clinical data management systems and/or EDC products (e.g. Oracle RDC / Inform, Medidata RAVE, etc)

　　• Knowledge of clinical research, FDA & ICH GCP and related global regulatory requirements

　　• Understands the current and future trends within the BioPharma Industry and is able to adapt training programs to suit

　　• Knowledge experience pertaining to training methodology (development/delivery) and tools to support learning

　　• Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in an matrix environment

　　• Proficient in commonly used office software including Outlook, Word, Excel, and PowerPoint with learning ability to new applications

　　NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

　　Ability to travel approximately 5 to 10%

　　ORGANIZATIONAL RELATIONSHIPS

　　Reporting relationship to Director, PTRA, CDS.Provides training Support to CDS colleagues and other process groups within Pfizer.

　　Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

　　Medical