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Clinical Data Standards Specialist (Associate Director)


Groton, CT
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Job Details

Clinical Data Standards group will support and maintain all business related enterprise level activities regarding clinical trial data standards. The Data Standards Specialist will ensure the quality and consistency of clinical trial data standards used in studies conducted internally, at partner companies (CROs, Functional providers) and the data contained within the Pfizer repository towards the ultimate objective of data quality and consistency across programs and systems **.** Create, maintain and assume accountability for a culture of high customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment.


The major duties & responsibilities will include but are not limited to:

+ Progressing new CDISC aligned clinical data standards with a governance structure for ensuring consistency and compliance across Therapeutic Areas and with our CROs to support the exchange of data .

+ Key member of the global and Therapeutic Area (TA) standards governance boards to define, maintain and enforce standards across the Business Units while ensuring consistency for both internal and external run studies.

+ Responsible for defining standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements).

+ Primary standards liaison with internal DM organization and DM CROs to resolve any standards implementation issues.

+ Serve as a subject matter expert and information resource on all aspects of standards development that includes industry standards (CDISC), regulations, processes, business policies and any applications supporting standards development.

+ Interface with internal safety organizations and councils (e.g. Suicidality, pediatrics, neurosciences, etc) and legal on standards issues (e.g. privacy laws) coordinating with partners.

+ 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.

+ Participate in the strategy and implementation of CaPS (CDISC and Pfizer Standards are sponsor-aligned CDISC standards) while maintaining our legacy standards, PDS until retirement.

+ Collaborate with appropriate personnel to ensure that decisions regarding standards support medical and statistical criteria, regulatory and legal mandates (e.g. privacy laws)

+ Implement future strategies and technology-enabled processes and tools for clinical trials standards, change control and the exchange of standards information internally to downstream users and externally with our CROs

+ Collaborate with internal stake holders, BT and external vendors to ensure implementation of tools and efficient data standard processes.

+ Align goals for standardization with other the COE and GBDM functions (e.g. Electronic Health Records, programming, clinical data warehouse).

+ Key member of the Governance Boards, responsible for the change control management of standards, documentation and business processes.

+ Collaborate with Clinical Trial Solutions (CTS), Business Technology (BT) and any external vendors in the development of data exchange plans, specifications and validation of the aggregated environment or other BT solutions for Data Standards.

+ Communicate standards related information globally.


+ Bachelor's degree or equivalent in a scientific discipline required. Master's degree in Statistics, Computer Science or related field or equivalent experience preferred. At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.

+ Experience in Data Management, or Clinical Trial Operations with a clear understanding of clinical data from internal as well as external sources.

+ Demonstrated knowledge of metadata management and pharmaceutical industry standards (CDISC).

+ Strong track record of building successful relations with supervisors, peers, direct reports, suppliers, customers, partners and stakeholders is essential

+ Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions

+ Demonstrated experience to manage complex projects and cross-functional teams including delivering to project and portfolio metrics.

+ Demonstrated strong communication, interpersonal and negotiating skills in relating to colleagues and associates internal/external to the organization and leveraging of those competencies to ensure continuous progress

The candidate will have significant clinical data and/or trial management experience and with technical expertise in standards management and implementation. Experience in the areas of design, support of large scale distributed databases and data standards administration. Demonstrated ability to handle multiple tasks and projects as well as effective written and verbal communication skills relating to colleagues and associates both inside and outside the organization.

**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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