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Clinician

3.00 to 0.00 Years   Chennai   03 Jul, 2021
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

ROLE SUMMARY

  • Responsible for the clinical and scientific aspects of clinical trials at the study level.
  • Works with the Clinical Sub-team and Study Team responsible for the design, execution, monitoring and reporting of global or regional Phase 1-4 clinical trials in various disease areas.
ROLE RESPONSIBILITIESClinical Development Responsibilities (including but not limited to the following)
  • Works collaboratively with the Clinical Lead and members of the Clinical Sub-Team to develop clinical deliverables (e.g., clinical plans, protocol, clinical study reports, and clinical components of regulatory submissions).
  • Collaborates with multifunctional study team (clinical, clinical pharmacology, statistics, clinical operations, regulatory, safety, etc.) to design, conduct and report assigned clinical studies ensuring that all activities are fully aligned with Pfizer SOPs, guidelines and regulatory requirements.
  • Provides clinical input to all study team deliverables (e.g., monitoring guidelines, analysis plans, etc.).
  • Collaborates with study management staff to identify, evaluate and select clinical sites and investigators.
  • Works with study team to ensure high quality of data (e.g., appropriate patient population, adequacy of clinical assessments, etc.), as study is ongoing.
  • Together with the Clinical Lead is responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety.
  • Provides clinical input on labeling, responses to regulatory queries, and other maintenance and defense-related activities.
  • Contributes to the development of publications, abstracts, presentations, and clinical trial data disclosures.
Physician-Clinician Responsibilities (additional responsibilities for Medically-qualified clinicians)
  • Performs and documents regular review of safety data from assigned clinical studies consistent with the Safety Review Plan.
  • Serve as primary contact with external investigators and internal study team for questions relating to medical aspects of the clinical trial protocol.
QUALIFICATIONS
  • MD or equivalent
  • At least 3 years of experience in the pharmaceutical industry designing and executing Phase 1-4 clinical trials
  • Strong teamwork and the ability to work effectively in a matrix environment
  • Excellent communication skills and proven scientific writing ability
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical #LI-PFE,

Keyskills :
study reportsclinical trialswork effectivelyscientific writingclinical operationsclinical pharmacologylegislative relationspharmaceutical industryclinical studyclinical trialdesignmatrixtrialswritingmedical

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