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Clinical Scientist (Sr Manager)

Pfizer


Location:
Milano, TX 76556
Date:
01/30/2018
2018-01-302018-03-02
Pfizer
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Job Details

**Mission**



The Clinical Scientist is responsible for bringing together clinical, scientific and technical disciplines to ensure high quality protocol development, study execution and data interpretation. They will be responsible for clinical sciences deliverables on one or more interventional clinical trials, with the opportunity to work across multiple Therapeutic Areas within Global Product Development (GPD).



The Clinical Scientist is a key member of the study team and partners closely with the Therapeutic Area clinician and clinical operations team members, applying technical and scientific excellence to support the development and execution of clinical trials to meet the needs of internal and external customers.



Specific Clinical Scientist responsibilities impact key elements of the study lifecycle including protocol and Informed Consent Document (ICD)development, safety and quality data review, patient narratives and Clinical Study Report (CSR) development.







**Responsibilities**



Provides scientific expertise to produce clinical study protocol



Ensures appropriate Case Report Form design, creates ICDs, and is responsible for the election and implementation of Patient Reported Outcomes



Partners with data management to develop data review plan for review of data.



Responsible for establishing and management of Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes



Reviews patient level and cumulative data per the data review plan across a study and coordinates with TA Clinician for study level review.



Reviews protocol deviations.



Reviews safety data, Serious Adverse Event (SAE) reports, Targeted Medical Events, Designated Medical Events, and ensures clinical documents (eg. ICDs) are updated as required.



Tracks and reconciles SAEs across a study and reports SAEs during Safety Review Team meetings.



Collaborates with TA Clinician to provide medical/scientific guidance during the execution of the study.



Ensures Trial Master File compliance for clinical sciences study level documents.



Answers specific site protocol questions as needed.



Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, for Pfizer site facing roles and vendor / CRO staff.



Identifies scientific quality issues to discuss with clinicians and operations study team members so that corrective actions may be instituted.



Provides scientific input to and review of CSRs including writing of narratives.



At the asset level, assists the Global Clinical Lead and TA Clinician in the preparations of the clinical content of regulatory submissions/documents (e.g. (supplementary) New Drug Application, Marketing Authorisation Application, Investigational New Drug, Investigators Brochure (IB), Annual Report, medical narratives).



May support and contribute to various sections of regulatory documents (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, Periodic Safety Update Reports, and Regulatory authority responses).







**Qualifications**



Required: BA/BS or equivalent qualification.



Preferred: Ph.D., Veterinary Medical Doctor, M.S., and/or PharmD. or equivalent qualifications. Postgraduate training/certification/ fellowship in a clinical / scientific discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).



Knowledge and experience in Good Clinical Practices



Experience in execution of clinical trials, including data review and investigative site relations



Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval)



Practical experience in clinical trial strategies, methods and processes



Track record of design, oversight and interpretation of clinical studies



Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data.







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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