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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in oncology clinical development, regulatory submission processes, and vendor management while ensuring compliance with Good Clinical Practice (GCP). Proven ability to lead cross-functional teams and manage complex clinical operations across multiple regions.
Highest-signal resume keywords
Oncology Clinical DevelopmentVendor ManagementGood Clinical Practice (GCP)Regulatory Submission SupportBudgeting and Forecasting
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 OperationsClinical Project ManagementPhase II-III ProgramsOperational Feasibility AssessmentsRisk ManagementScenario ModellingQuality OversightInsourcing vs Outsourcing RecommendationsBio-Sample ManagementDiagnostic Implementation
Soft Skills
Stakeholder ManagementCommunication Skills
Certifications & Qualifications
Bachelor’s Degree in Life Sciences
Industry Keywords
Contract Research Organization (CRO)Clinical Development ProcessesGlobal Study OversightMatrix TeamsMentoring
About the role
Key responsibilities & impact- Lead and support operational strategy and delivery for assigned late phase development streams, ensuring alignment with the clinical development plan.
- Coordinate cross-functional inputs from clinical, biostatistics, safety, clinical supplies and vendors to meet timelines and quality expectations.
- Represent DevOps at EDT/MDT.
- Contribute to protocol development, operational feasibility assessments and resourcing decisions, including insourcing versus outsourcing recommendations.
- Maintain inspection readiness and quality oversight, supporting risk management, mitigation plans and serious breach escalation when needed.
- Provide operational input for regulatory deliverables and governance forums, including scenario modelling and budget forecasting for clinical activities.
- Act as a point of contact for stakeholders and vendors to ensure consistent execution across studies and sub-projects.
Requirements
What you’ll need- Bachelor’s degree in life sciences, health sciences or equivalent qualification.
- Experience in oncology clinical development.
- Experience in vendor management and oversight of Contract Research Organization (CRO) relationships.
- Experience working in roles requiring application of Good Clinical Practice (GCP) and clinical development processes.
- Experience delivering global study oversight across multiple regions.
- Experience managing multiple stakeholders and communicating in written and verbal English in a professional setting.
- Experience in Phase II-III programs.
- Experience working on complex, multi-indication programs.
- Experience in clinical operations, clinical project or program management.
- Experience contributing to regulatory submission content or supporting regulatory interactions.
- Experience with budgeting and forecasting for clinical studies.
- Familiarity with clinical supplies, bio-sample management or diagnostic implementation.
- Experience working in matrix teams and mentoring junior colleagues.
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in a share based long term incentive program
- Comprehensive benefits program for US employees
- Accommodation or other assistance to apply for a job, if required