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Associate Director, Clinical D...

Monster
 
 
 
 

Job Summary

Company
Pfizer
Location
Collegeville, PA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4903_4703671

Associate Director, Clinical Data Standards Lead, Central Services

About the Job

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 SOP’s 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.

QUALIFICATIONS

  • Bachelor’s degree in a scientific discipline. Master’s degree in Statistics, Computer Science preferred.
  • At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.  Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation preferred. 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
  • Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC/InForm preferred)
  • Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC/InForm preferred
  • Experience using relational databases preferred (e.g. MDR, MS SQL Server, MS Access, or Oracle)

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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