1+ months

Director, IRT (Interactive Response Technology) Support Team

Pfizer
Groton, CT 06340
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The IRT Global Oversight Team (IGOT) is a well-established high performing team within Pfizer's Global Clinical Supply (GCS) unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.



**ROLE SUMMARY**

The IGOT Support Group Lead will oversee a global team that provides 24/7/365 support for Pfizer clinical trials using an internal IRT solution ensuring excellence in customer service and patient focus. This role will report to the Head of IGOT within Global Clinical Supply.



The IGOT Support Group Lead will work closely with IGOT's Management, Operations and Technical teams to ensure studies are effectively supported and system capabilities meet dynamic portfolio timelines and demands. This role will oversee vendors that support help desk functions, provide interface for regulatory audits and lead quality investigations and process improvement efforts in collaboration with applicable business partners.



For this position candidates will require excellent customer/patient focus, problem solving, communication and quality minded skills.



**ROLE RESPONSIBILITIES**



+ Provide management and oversight of IGOT Support (24/7/365 help desk) for Pfizer's internal IRT systems.

+ Point of escalation and management interface for issues related to ongoing clinical trials requiring support.

+ Manage vendors that support help desk functions monitoring performance, metrics, and training requirements.

+ Ensure business continuity of Pfizer's internal IRT systems through planned and unplanned outages and during non-working periods (e.g., holidays/weekends).

+ Partner closely with IGOT management and operational leads for overall portfolio review, resource and workflow planning, issue escalations, metrics and process optimization.

+ Ensure IRT processes are compliant with GCP & GMP guidelines and principles, 21CFR Part 11, and applicable regulations.

+ Lead quality/compliance investigations and issue resolution and serve as SOP owner for area of responsibility.

+ Lead and/or contribute to cross-functional initiatives that drive increased compliance, quality and efficiency across GCS.

+ Maintain a strong understanding of the nature of clinical data and concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards.



**QUALIFICATIONS**



+ B.S./B.A. degree is required, with 14+ years managing scientific or clinical projects in the biopharma industry.

+ A MS or MBA in business, information systems, supply chain desired.

+ Advanced knowledge of IRT systems, scientific, technical or clinical disciplines, business administration and/or people development are desirable.

+ Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams

+ Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus

+ Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram

+ Possess strong English language written and verbal communication, interpersonal, and collaboration skills required

+ Seamlessly work with a global team, partners and customers in a change agile environment



**PHYSICAL/MENTAL REQUIREMENTS**



+ Core Competencies include:



+ Dealing with ambiguity



+ Peer relationships



+ Acts decisively



+ Seizes accountability



+ Analytical capability to solve problems



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

Work hours will require some non-standard work times to manage a global team.



**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.



**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.



**"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve** **meaningful outcomes and create business impact."**



+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus



\#LI-PFE

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-09-05 Expires: 2019-11-09

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Director, IRT (Interactive Response Technology) Support Team

Pfizer
Groton, CT 06340

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