Evidence Delivery Associate Director, CL E.
Evidence Delivery Associate Director, CL E.
Posted on :
20-06-2025
Employer Active
1 Vacancy
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Job Description
Typical Accountabilities
- Plan and leadthe delivery of all components of a clinical development project.
- Act as leaderof the clinical development team ensuring consistency and oversight throughout the project lifecycle.
- Develop recruitment strategiesand ensure the delivery of approved Clinical Development Protocols.
- Collaborate with Line Managersto identify and secure resources from various departments for the timely formation of Clinical Study Teams and progression of deliverables.
- Forecast and managetimelines budgets materials project plans and feasibility assessments on a day-to-day basis.
- Lead and implementglobally agreed Clinical Development strategies including process and technology initiatives.
- Plan and leadactivities associated with audits in liaison with CQA; contribute to regulatory inspection strategy teams as required.
- Develop and managecontingency risk plans to assure timely delivery within quality standards budget and timelines; escalate issues to stakeholders as appropriate.
- Lead the preparation and deliveryof clinical development deliverables.
- Establish and maintainkey interactions with stakeholders.
- Plan lead and ensureappropriate training at Investigator and monitor meetings.
Coordinate and contributeto the timely delivery of Study Delivery components of submissions to regulatory authorities (e.g. CSRs CTDs INDs IND annual reports).
- Lead and optimizethe performance of study delivery teams ensuring GCP compliance; provide timely and accurate performance feedback for study team members to skill center managers.
- Foster a cultureof courageous leadership creativity and collaboration.
Global Remit
- The role operates ina minimum of 2 or 3 countries accounting for at least 40% of the time.
Education Qualifications Skills and Experience
Essential
- Bachelors degree in biological science or healthcare-related field.
- Experience in the pharmaceutical industry specifically in clinical study delivery or clinical development processes.
- Demonstrated leadership ability in a team environment.
- Experience with project management methodologies.
- Advanced knowledge of clinical study and drug development processes and GCP/ICH guidelines.
- Excellent written and verbal communication skills with proven negotiation collaboration and interpersonal leadership abilities.
- Experience in budgetary and resource management planning.
- Willingness to travel domestically and internationally.
- Fluent in spoken and written English.
- Team oriented flexible and able to respond quickly to shifting demands and opportunities.
Desirable
- Proven ability to plan coordinate and facilitate delivery of team objectives.
- Demonstrated project management skills and operational expertise in risk management and contingency planning.
- Solid understanding of disease states and familiarity with current research and thought leadership.
- Extensive knowledge of clinical study/drug development processes GCP/ICH guidelines and SOPs.
- Ability to understand the impact of technology on projects and to use/develop relevant computer skills with proficiency in AZ and Study Delivery systems/software.
- Conceptual analytical and strategic thinker.
- Effective at problem solving and conflict resolution; demonstrated team focus and cooperation.
- Willingness to learn from others and share relevant information for team success.
Key Relationships
Internal (within AZ)
Study Delivery personnel
- Data Management Centre representatives
- Clinical Project Team and therapy area personnel
- Clinical Development personnel
- Clinical Pharmacology Units
- Study Site personnel
- Regional Monitoring personnel
- Other Skill Centres as appropriate
External (to AZ)
- External service providers
- Marketing Company personnel
Date Posted
18-jun-2025Closing Date
21-jun-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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