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Senior Manager, Protocol Operational Lead


New York, NY
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Job Details


The Protocol Operational Lead (POL) will provide operational support and direction for non-interventional studies (NIS) to the Health Economics and Outcomes Research (HEOR) team in compliance with Pfizer Standard Operating Procedures (SOPs).

The POL will work very closely with the HEOR, clinical, and medical teams and be responsible for the following:

+ Designing, planning, implementing, training, and executing the operational direction of NIS from protocol planning, and development, including selection and qualification;

+ Training of vendors/investigational sites, and operationalization of study activities in line with SOPs using all Pfizer systems required for study compliance and tracking;

+ Assisting in the preparation and review of outcomes study reports.

This role will report directly to Senior Director, the Real World Data & Analytics (RWDnA) Methods & Algorithms Lead.


+ Be responsible for supervising and maintaining Operational Plans (e.g. oversight, Data Management, Study Monitoring, Quality Assurance, and Risk Management Plans);

+ Be responsible for essential study documentation and inspection readiness compliance requirements on an ongoing basis depending on the study type;

+ Track actual activities vs planned milestones and communicating to the study team when deliverables are at risk;

+ Manage operational meetings and project activities (e.g. safety requirements, safety reporting monitoring, compliance steps, data transfer, close out activities, QA of study report, etc.);

+ Develop informed consents, global review, and approval forms in accordance to the protocol and in compliance with Pfizer SOPs and ICH/GCP requirements;

+ Ensure the correct Pfizer training appropriate to the study is completed by all Vendors on an ongoing basis based on the latest available Pfizer training requirements;

+ Develop tools to improve compliance with SOPs by internal colleagues.


+ Degree: BA/BS required, advanced degree preferred, in Pharmacy, Medical, Epidemiology, or a related field;

+ A minimum of 8 years of experience in managing clinical operation for outcomes studies;

+ Excellent oral and written English communication skills required;

+ Ability to work in cross-functional teams;

+ Strong project management abilities.

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: April 16, 2018**

+ Eligible for Employee Referral Bonus

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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