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AstraZenecaCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Study Processes, ICH-GCP guidelines, and project management while effectively leading teams and managing resources to deliver high-quality clinical trials. Proficient in both spoken and written French, with strong interpersonal and communication skills to foster collaboration and influence stakeholders.
Highest-signal resume keywords
Clinical Study ProcessICH-GCP GuidelinesProject ManagementLine Management ExperienceFluency in French
About the role
Key responsibilities & impact- Deliver the committed part of all clinical interventional studies under supervision according to resources, budget, timelines, AZ Procedural Documents, ICH-GCP and local regulations.
- Line manage dedicated staff groups and plan staff resource utilization, budgets, objectives and performance follow-up.
- Contribute to regional/global work tasks as delegated.
- Ensure study sites are identified, qualified, set up, initiated, supervised, closed and archived.
- Lead dedicated groups, build team spirit, develop team style and behaviour.
- Ensure adequate study resources and direct-report workloads.
- Develop, coach and performance-manage direct reports, including training and development plans.
- Prepare salary and bonus proposals for direct reports with senior leadership and HR.
- Contribute to country-level SMM organization, feasibility work and study delivery targets.
- Improve study processes and procedures; maintain updated systems and inspection-ready eTMF.
- Forecast study timelines, resources, recruitment, materials and drugs.
- Direct local study teams on major commitments and resolve key issues.
- Support regional SMM initiatives and collaborate with Medical Affairs.
- Ensure country-level activities align with local policies and ethics codes.
- Review SQV reports and accompanied/co-monitoring/training/QC visits.
- Perform accompanied site visits under local QC plans, supporting coaching and development.
Requirements
What you’ll need- Bachelor degree in related subject area, preferably in life science, or equivalent qualification (*)
- Proficiency in both spoken and written french is a requirement.
- Minimum 5 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.
- Excellent interpersonal skills.
- Proven project management experience.
- Excellent organisational, analytical, influencing and negotiation skills.
- Excellent presentation and communication skills, verbal and written.
- Line management experience.
- Very good knowledge of the Clinical Study Process and international ICH-GCP guidelines.
- Excellent knowledge of the Monitoring Process.
- Good understanding of the Study Drug Handling Process and the Data Management Process.
- Good knowledge of relevant local and international regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Ability to deliver quality according to the requested standards.
- Ability to champion efficient and effective methods/processes for delivering quality clinical trials with reduced budget and in less time.
- Good ability to learn and adapt to work with IT systems.
- Ability for national and international travel.
Benefits
Comp & perks- Annual Variable Pay Bonus/Short Term Incentive opportunity
- Eligibility to participate in equity-based long-term incentive program (if applicable to role)
- Competitive Flex Benefits & Retirement Savings Program
- 4 weeks’ paid vacation
- Annual Personal Days
- Contract Benefits Program for Fixed Term Contract/Temporary positions (excluding students)
- Workplace accommodation for persons with disabilities
- Flexible ways of working
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Development OperationsMonitoring ProcessStudy Drug Handling ProcessData Management ProcessAnalytical SkillsNegotiation SkillsOrganizational SkillsPresentation SkillsQuality Standards DeliveryResource Forecasting
Soft Skills
Interpersonal SkillsInfluencing SkillsCommunication SkillsTeam LeadershipCoaching Skills
Tools & Technologies
ETMF SystemsIT Systems
Industry Keywords
Clinical TrialsLocal RegulationsEthics CodesFeasibility WorkSMM Organization