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Associate Director, Training Lead, Central Services, DMM

ROLE SUMMARY
As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Training Lead 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 Data Monitoring and Management (DMM) roles
+ Incorporates techniques of "accelerated learning" in the development and/or delivery of training
+ Sets learning goals in alignment with department and Pfizer goals
+ Sets learning targets for DMM roles that ensures a focus on both current Data Monitoring and Management practices and those that are evolving into Industry best practices
+ Develops specific training materials to support DMM stakeholders group knowledge
+ Develops assessment tools intended to ensure process and technical knowledge is sufficient
+ Maintains the DMM role training curriculums and acts as the DMM Point of Contact for developing educational materials within the larger Pfizer learning network
+ Ensures that leading edge learning techniques are in place to support learning within the department
+ Supports communication activities within department designed to educate and build awareness within and outside of department related to data monitoring and management topics
QUALIFICATIONS
+ Bachelor's degree required. Preference for degree in scientific field at a Master's level.
+ 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)
+ Minimum 5 years Data Management experience required including 5+ years in a training development role
+ 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
+ Ability to travel approximately 10 to 20%.
QUALIFICATIONS
+ Bachelor's degree required. Preference for degree in scientific field at a Master's level.
+ 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.)
+ Minimum 5 years Data Management experience required including 5+ years in a training development role
+ 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
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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