PCRU Study Manager at Pfizer in New Haven, Connecticut

Job Description:

Why Patients Need You

 

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

 

What You Will Achieve

 

You will be part of Pfizer's medical team and man a ge the clinical studies. Your project management skills will be leveraged for planning, directing, creating and communicating timelines. You will ensure that the clinical studies are within time, budget and scope.

 

As a Study Manager, you will:

 

• Have responsibility for study management activities for all PCRU assigned studies of all levels of complexity
• Support the execution of clinical trials from Study start-up through Database. Study Managers may also input to and support compilation of sections in Clinical Study Reports
• Be a core member of the Study Team
• Apply knowledge and skills while working with functional lines (study & site level) to resolve or triage issues

 

It is your problem-solving ability and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

 

How You Will Achieve It

 

Responsible for Study Management and oversight of all PCRU only studies (all complexities)

 

• Works independently with deliverables across multiple groups/teams supporting a large number of studies
• Supports inspection readiness activities related to study management and site readiness

 

Key tasks / activities

 

• Point of contact for PSSA onboarding
• SToD - ensures the study operational tools (Roster, System List, Vendor List) are current from a Study Management perspective for the duration of the study including the 2 Deep Dives per year.
• May serve as the IB Handoff contact
• SSDL - respond to any questions about SM placeholders. Provide vendor details.
• TMF - respond to any questions about SM documents. At the end of the study, ensures all SM documents have been completed/filed.
• Responsible for creation of the Study Training Plan
• Firecrest - setup, PST date entry for designated roles, closeout (Firecrest training logs, Firecrest Closeout Report)
• GCP Report (BR only - provide to BR Pharmacy for IIP confirmation of GCP training compliance)
• CSR - Ensure PI is included on the CSR reviews, forward questions directed to the SM to the PI. Responsible for 3 Appendices including signing the Appendices confirmation form. Review the CRO Appendix which is completed by the CSTA.
• Ensure the PCRU lab coordinators are aware of the CSR Timelines so that the CT29-GSOP documents can be completed prior to final CSR.
• CSDS - responsible for ordering the drug supplies in CSDS. Forward any CSDS communications to appropriate study team members (e.g., IRB approval expirations, upcoming study drug expirations)
• IP manual review/approval.
• Respond to any questions that are sent my way as the 'SM'. Usually this involves directing them to the appropriate contact.

 

Study Team Interface

 

• Supports study startup, execution and closeout to ensure delivery & compliance with all applicable Standard Operating Procedures and Quality Standards
• May work proactively with data management functions to ensure alignment on data flow and timely delivery

 

Subject Matter Expertise

 

• Have comprehensive knowledge of and an SME for study management systems (e.g. Firecrest, SToD, PSSA,) and processes
• Will champion the implementation and use of harmonized, consistent processes, and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
• For project-specific audits and inspections, can serve as a resource to the study team to facilitate the audit/inspection.

 

Qualifications

 

Must-Have

 

• BS in relevant area (e.g. life sciences)/Nursing Degree with a minimum of 5+ years of relevant experience OR MS/Ph.D. with a minimum of 3+ years of relevant experience
• Global clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• Can operate within cross-functional teams
• Understands how to work with vendors to accomplish tasks
• Ability to proactively identify & mitigate risks around site level in study execution
• Understands feasibility of protocol implementation
• Global- and Country-level cultural awareness and strong interpersonal skills
• Keen problem-solving skills
• Excellent communication skills, both written and verbal. Must be fluent in English.
• Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)

 

Nice-to-Have

 

• Master's degree
• Study Management / Leadership experience
• Knowledge of the project management discipline

 

Work Location Assignment: Hybrid

 

The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

 

Relocation assistance may be available based on business needs and/or eligibility.

 

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. This position requires permanent work authorization in the United States.

 

Medical

 

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