Ensures scientific integrity and participant safety in clinical trials
Designs and executes high-quality studies
Maintains compliance, manages risks and emerging clinical issues
Supports interpretation and communication of clinical data
Leads clinical execution of one or more studies of medium - high complexity
Provides clinical input to development of protocol design document (PDD)
Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions
Reviews and approves final document and Risk Management and Safety Review Plan

Requirements

Advanced degree or professional certification in a health care related, scientific or technical discipline required
BA/BS with 8+ years of experience, MBA/MS with 7+ years of experience, PhD with 5+ years of experience
Clinical research experience in phase 3/pivotal space
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
Demonstrated clinical, administrative, and project management capabilities
Excellent verbal and written communication skills in English
Demonstrated experience establishing, managing, and training teams in clinical development

Benefits

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchprotocol designInformed Consent Documentsadverse event managementproject managementclinical data interpretationrisk managementstudy designclinical trial executioncompliance management

Soft Skills

communication skillsleadershipteam managementadministrative skillsorganizational skills

Certifications

advanced degreeprofessional certification