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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical operations, including study management, vendor oversight, and compliance with ICH/GCP guidelines. Proven ability to lead cross-functional teams and deliver clinical studies on time, within budget, and to quality standards.
Highest-signal resume keywords
Clinical Study ManagementVendor OversightGCP ComplianceProject ManagementRisk Mitigation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsStudy Lifecycle ManagementFeasibility AssessmentRecruitment ManagementBudget TrackingSafety ManagementDeviations ManagementArtificial Intelligence ToolsMachine Learning ToolsStudy Design Knowledge
Soft Skills
Problem-SolvingInfluencing SkillsStakeholder CommunicationTeam LeadershipPeople Skills
Industry Keywords
ICH GuidelinesGCPsPharmaceutical EnvironmentScientific EnvironmentFull-Service Outsourcing
About the role
Key responsibilities & impact- Deliver clinical operation activities for studies from Commit to Study Initiation (CSI) through study archiving
- Generate robust and accelerated delivery plans to target or stretch thresholds with quality
- Work in consultation with the Global Study Lead for end-to-end clinical study delivery
- Act as Working Group Lead for Clinical Operations
- Lead operational delivery of clinical studies to time, quality, budget, company standards, and scientific requirements
- Support rapid decision-making and lead the study team to achieve overall study deliverables
- Own deliverables including Study Initiation Meeting, Activity & Delivery Plans, Vendor Oversight & Results Dissemination Plans, Recruitment & Budget Tracking, and Safety & Deviation Management Plans
- Support assessment and selection of Full-Service Outsourcing vendors and oversee them according to the FSO handbook
- Assess and select study vendors under GCSD responsibility in consultation with the Global Study Lead
- Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and SOPs
- Identify, oversee, and mitigate study risks
- Ensure stakeholder communication regarding study status, expectations, risks, and issues
- Promote use of Artificial Intelligence and Machine Learning tools to automate manual processes and improve efficiency
Requirements
What you’ll need- Relevant degree-level education (e.g., life sciences or related discipline)
- Relevant clinical research, study management, and operations experience in a pharmaceutical/scientific environment
- Hands-on experience across the study lifecycle, including feasibility, start-up/recruitment, vendor management, and close-out
- Experience working across multiple types of study designs
- In-depth knowledge of GCPs and ICH guidelines
- Good project management skills, including scope, budget, timeline, and resource planning and management
- Experience working in a complex matrix environment
- Demonstrable clear problem-solving approach
- Strong people skills
- Proven ability to influence people to achieve and drive performance
Benefits
Comp & perks- Hybrid (Remote & On-site) working arrangement
- Agile working culture and flexibility opportunities
- Equal opportunity employment
- Recruitment process adjustments available for applicants who require them