Director - Clinician - Pfizer - Collegeville

Job description

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
The Clinician is accountable for the design and implementation of clinical studies aligned with the overall clinical development plan. The Clinician is also responsible for overseeing all aspects of clinical trial participants' safety and for providing medical guidance during the design, execution, and reporting for clinical studies.

In addition to study level activities, the Clinicia will participate on Clinical Project Teams, participate in standing committees such as Vaccine Clinical Research Committee (VCRC), may review compounds for potential in-licensing including performance of due diligence reviews and may provide assistance to New Business Development on Market Opportunity and Target Product Profile.

The Clinician will review and participate in regulatory document submissions and will also be involved in study results reporting and publications.

Responsibilities
DESIGN PROTOCOL AND STRATEGY
*Design clinical studies to meet the stated objectives. Directs Clinical Scientists (CSs) in writing the synopsis and protocol
*Approve protocols and amendments
*Approve Informed consents
*Provide medical input into country and investigational site feasibility
*Coordinate with the Clinical Scientist (CS) to review and approve processes for data capture and review

PROVIDE STUDY TEAM WITH MEDICAL EXPERTISE DURING KEY ACTIVITIES
*Protocol training for investigators
*Issue resolution
*Audit responses
*Study closeout
*Inspection Readiness
*Review Informed Consent Forms (ICFs)

ACCOUNTABLE FOR SAFETY ACROSS THE STUDY
*Ensures development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the CMM may delegate these responsibilities to the study clinical scientist identified in the SRP. The specific components of safety data review are detailed in the Safety Data Review Guide - for Clinicians and in SAF09 SOP.
*Review individual subject data (including adverse events, serious adverse events, and other safety data) and potentially clinically important findings, as well as determine if follow up is needed
*Review all adverse events narratives
*Participate in Safety Review Team (SRT), interact with Data Monitoring Committee (DMC) and steering committees as required
*Provide responses to questions on safety: reviews literature as needed to respond to safety questions or those posed by the SRT, DMC or other individuals or bodies involved with the study
*Communicate safety information to sites across the study

STUDY LEVEL DATA REVIEW
*Perform review of data generated by statistical analyses
*Request additional tables or analyses as indicated
*Perform reviews and procedures required for database finalization

ANSWER AND RESOLVE MEDICAL AND SAFETY QUESTIONS FROM SITES
*General protocol questions, questions on inclusion/exclusion, etc.
*Ensures answers are consistent across study regions

INTERACT WITH REGULATORY AUTHORITIES (RA) AND INTERNAL REGULATORY AND AUDITING GROUPS ON A STUDY LEVEL
*Data Monitoring Committee
*Support RA interaction, accountable for providing responses to RA inspection observations and internal audits
*Support RA updates and registration submissions
*Particiate in regulatory submisions

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