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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive knowledge of the clinical research process, Good Clinical Practices (GCPs), and the ability to lead observational and epidemiological studies. Proficient in study design, data analysis, and regulatory submissions, with a strong emphasis on collaboration and vendor management.
Highest-signal resume keywords
Study DesignEpidemiological StudiesRegulatory SubmissionsVendor ManagementData Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study DesignData AnalysisClinical Research ProcessGood Clinical Practices (GCPs)Protocol DevelopmentStatistical AnalysisData InterpretationProject ManagementOperational LeadershipIndependent Authorship
Soft Skills
CollaborationLeadershipInfluencingIndependent WorkCommunication
Industry Keywords
Observational StudiesEpidemiological ResearchClinical OperationsRegulatory InspectionsResearch CollaborationsCRO ManagementGlobal StudiesTherapeutic Area KnowledgeMatrix OrganizationStudy Oversight
About the role
Key responsibilities & impact- Provides leadership in conduct of observational study execution including epidemiological, non-interventional, pragmatic and low-interventional studies and research collaborations
- Responsible for execution and project management of studies as well as oversight of studies executed by CSs supporting the product
- Collaborates with other Pfizer groups and oversees vendors to execute the studies
- Responsible for numerous observational and epidemiological studies run as Pfizer-sponsored and/or as non-Pfizer sponsored Research Collaborations
- Leads via a matrix organization to execute studies
- Protocol and protocol specific training
- Vendor management
- Study level planning and oversight
- Data review
- Regulatory document, study report and publication preparation and review
- Influences management/senior staff decisions and is viewed as the Subject Matter Expert on CS decisions impacting a study/program
- Provides CS leadership role in preparation of regulatory submissions, responses to regulatory queries, and in preparation for program regulatory inspections and audits
Requirements
What you’ll need- BA/BS Degree in life sciences or health related field with 10+ years practical experience or MS/MBA with 8+ years, PharmD/PhD 6+ years and MD/DO with 3+ years.
- Hands-on experience in study design, conduct and analysis.
- Experience working on global teams/studies
- Significant experience leading operational and/or strategic study teams
- Ability to work independently and collaborate with multiple functional groups within and outside (e.g., outside CROs/vendors) company
- Demonstrated advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols
- Extensive knowledge of the clinical research process and Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
- Solid knowledge of therapeutic area
- Demonstrated independent authorship of study protocols and other study documents
- Working knowledge of statistics, data analysis, and data interpretation
- Experienced in managing external vendors for clinical and/or epidemiological study(ies)
Benefits
Comp & perks- Position requires travel (10%) both domestic and international
- Weekend and evening work likely to be required based on project needs
