• Associate Director , Clinical Data Standards Lead Jobs in United States Of America - 25367906

  • Pfizer Inc.
  • United States Of America, Usa
  • Save Job
  • 10 - 13 Years
  • Posted : above 1 month

Job Description:

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 Clinical Data Standards Lead is responsible for the integrity of clinical trial data standards The Clinical Data Standards Lead will ensure the quality and consistency of clinical trial data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems The Clinical Data Standards Lead will be accountable for the timely and high quality delivery of clinical trial standards in support of the Pfizer portfolio The Clinical Data Standards Lead may oversee vendor and off-shore colleague deliverables supporting standards implementation

ROLE RESPONSIBILITIES

Collaborates with department roles, cross-functional study team members and other functional lines to create data standards solutions that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards that supports the exchange of data
Serve as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, legal mandates, processes, and business policies
Key member of the global and Therapeutic Area (TA) standards governance boards to define, maintain and enforce standards across the Business Units to ensure consistency for internal and external run studies
Ensure work carried out in accordance with applicable SOPs and working practices
Key data standards contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer
Directly supports knowledge development of others as a subject matter expert on data standards, change control management and related tools/applications
Creates quality control processes, metrics and other measures to ensure compliance with standards
Creates any needed documentation and training for standard processes, change control management and tools
Responsible for defining standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements)
Facilitate a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation
Support and Implement future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers

BASIC QUALIFICATIONS

Bachelors degree in a scientific discipline
At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency Experience in the areas of design, support of large scale distributed databases and data standards administration
Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
Demonstrated experience managing multiple tasks, complex projects and working with cross-functional teams delivering to project and portfolio timelines and metrics
Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in an matrix environment

PREFERRED QUALIFICATIONS

Masters degree in Statistics, Computer Science
Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation
Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC/InForm)
Experience using relational databases (eg MDR, MS SQL Server, MS Access, or Oracle)

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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