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Training Lead, Clinical Data Management

5.00 to 7.00 Years   Chennai   22 Oct, 2021
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

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.JOB RESPONSIBILITIES:

  • Develops, maintains, schedules and delivers role based training programs to 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 / SKILLS:
  • Bachelor s/Masters degree, preferably in scientific field
  • Minimum 10-15 years experience in Data Management required including 5 years in a Training and Development role
  • 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.)
  • 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
  • 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
ORGANIZATIONAL RELATIONSHIPS:
  • Reporting relationship to Senior Director, Head of India Data Monitoring and Management, Clinical Data Sciences, DMM
  • Provides training Support to DMM colleagues and other process groups within Pfizer
#LI-PFEPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical #LI-PFE,

Keyskills :
trainingcustomer servicecustomer relationscalibrationcoachingclinical data managementequal employment opportunityclinical datafuture trendsdata managementclinical trialsdata monitoringassessment tools

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