Medical Operations Associate

The Enterprise Clinical Trial Data Sharing program (CTDS) provides operational management for requests from an external researcher, research institution, or research consortia for data generated from Pfizer-sponsored interventional studies. Pfizer will provide access to de-identified patient-level data in response to valid research proposals. 

ROLE SUMMARY

The CTDS colleague will be responsible for operational execution and oversight for all processes (from submission to data package upload) related to supporting Pfizer’s CTDS program for operational execution, oversight, and compliance supporting Pfizer’s clinical trial internal and external data sharing commitments.

ROLE RESPONSIBILITIES

• Serves as a point of contact for internal & external clinical trial data requests – ability to review and triage requests for completeness and perform appropriate follow-up with external and internal stakeholders.

• Manages tracking status of all clinical trial data requests and proactively identifies requests that are at risk for delays in dissemination of data – works with internal and external stakeholders to remediate and resolve. Provides detailed metrics and other information related to data requests.

• Maintaining systems, Share Point sites and databases used for program management and operational excellence.

• Perform quality control procedures on data requests to data package issuance, publications related documents & system data according to corresponding Pfizer SOPs and guidelines.

• Provide expert input to respond directly or indirectly to new business questions and challenges from leadership, while anticipating future needs and proactively addressing as appropriate.

• Possess strong business acumen and ability to navigate across functional lines, progress deliverables when there is ambiguity, anticipate business needs and demonstrate flexibility by adapting to changing business.

• Provides metrics and other compliance‐related information to senior leadership related to the products and/or studies within their remit.

• Apply expertise to identify areas for continuous improvement in the data sharing processes and systems, providing feedback to leadership as appropriate.

• Support across the larger Expanded Access and Clinical Disclosure Team as needed, depending on business need.

• Ability to travel to the Warsaw office as needed

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QUALIFICATIONS

• Bachelor’s degree (BA, BS) required with preference for a focus in science, healthcare, or related field.

• Excellent writing skills and ability to edit, summarize and interpret complicated content effectively and concisely for better understanding.

• High fluency in written English and strong functional fluency in spoken English.

• Strong organizational skills, attention to detail, and ability to prioritize multiple projects and meet deadlines.

• Ability to take initiative and work independently.

• Comfortable asking probing questions to clarify unclear data requests.

• Operational experience in clinical trial management or healthcare industry (pharmaceuticals, life sciences, and medical).

• Software: Word, PowerPoint, Excel is preferred. AI practical knowledge is a must.

• Developed customer service skills and teamwork spirit.

• 1-2 years’ experience in pharma, a full time pharma internship, or closely related scope.

OTHER REQUIREMENTS

• Ability to travel 10% - 20%

• Ability to appear at Warsaw Pfizer site.

PAY TRANSPARENCY NOTE

What we offer:

• Job contract in Pfizer

• Minimum annual gross base salary of 100 500 PLN

• Annual bonus: 10%

• Customized benefits package (e.g. medical care, life insurance, Multisport, daily fruits, Christmas gifts, educational workshops and trainings, language learning support, etc.)

• International and supportive culture with development opportunities.

 
 

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