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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site management and activation, with a strong focus on regulatory compliance and Good Clinical Practice (GCP) guidelines. Proven ability to build relationships with stakeholders and manage cross-functional teams to ensure successful study execution.
Highest-signal resume keywords
Site ManagementStart-Up ActivitiesGood Clinical Practice (GCP)Regulatory RequirementsCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site ActivationStudy ConductClose-Out ActivitiesFeasibility StrategyProtocol DesignInvestigational Product ManagementAnalyticsDocumentation ManagementIssue ResolutionSite Recruitment
Soft Skills
Interpersonal SkillsNetworking SkillsRelationship-Building SkillsAdaptabilityPresentation Skills
Tools & Technologies
Pfizer SystemsEPRODTPClinical Trial Operations SoftwareSite Activation Checklists
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
Clinical TrialsInvestigational Medical ProductsCountry-Specific GCP RequirementsSite OrganizationsStudy Operations
About the role
Key responsibilities & impact- Serve as Pfizer’s key point of contact for investigative sites throughout the study lifecycle
- Manage site start-up and activation activities
- Qualify and activate assigned sites using GSSO site strategies
- Support country and site selection, feasibility strategy, analytics, and protocol feasibility activities
- Provide country/regional input to country strategy, feasibility, protocol design, and outreach surveys
- Coordinate site activation checklist items, ICD finalization, SIV activities, documentation, systems, and issue resolution
- Ensure site initiation training, readiness, and follow-up activities through first subject first visit
- Partner with CRA/Site Monitor to ensure monitoring readiness and support investigator relationships
- Provide study support for escalated site delivery issues, including vendor, contract, and payment issues
- Manage investigational product and ancillary supply strategies throughout the study lifecycle
- Plan and support site recruitment and enrollment activities
- Coordinate with local regulatory and clinical trial operations stakeholders
- Establish and maintain relationships with site organizations and strategic partners
- Support study conduct, site report review, annual SMO assessments, and close-out activities
- Support decentralized capabilities such as home health, ePRO, and DTP
- Act as a subject matter expert on Pfizer systems and processes
- Develop efficiencies and best practices to improve site performance and investigator/site satisfaction
- Maintain clear communication with the Study Operations Manager and Global Study Manager
- Provide local and cluster-level intelligence for country strategy, site recommendations, and territory development
- Support local requirements for import/export processes involving investigational medical products and ancillary supplies
Requirements
What you’ll need- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- At least 7 years’ experience
- Ability to manage required travel of up to 75% on a regular basis
- English is required; proficiency in local language preferred
- Experience in site management, with prior experience as a CRA/Site Monitor
- Demonstrated experience in start-up activities through site activation
- Demonstrated experience in conduct and close-out activities
- Demonstrated knowledge of quality and regulatory requirements in applicable countries
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Networking and relationship-building skills
- Ability to manage cross-functional relationships
- Ability to communicate effectively with internal and external stakeholders
- Ability to adapt to changing technologies and processes
- Knowledge of country-specific GCP requirements
- Candidates must be authorized to be employed in the U.S. by any employer
- Permanent work authorization in the United States is required
- U.S. work visa sponsorship is not available now or in the future
Benefits
Comp & perks- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Medical, prescription drug, dental and vision coverage
- Relocation assistance may be available based on business needs and/or eligibility
- Participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary
- Eligibility to participate in Pfizer’s share based long term incentive program
