Astrazeneca
Healthcare
AssociateDirector,ClinicalTrialSafetyScientist
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“Associate Director, Clinical Trial Safety Scientist at Astrazeneca. Skills: Clinical trial safety, Data review methodology, Team leadership. Oversee work of scientists. Ensure scientific quality of data review”
Industry & Context.
Analytical skills
What They're Looking For.
Must Have
Advanced university degree, Minimum 3 years experience, In-depth understanding of clinical study, Extensive knowledge of regulations, Strong team leadership skills, Proven stakeholder management skills, Ability to manage change, Excellent English communication
Nice to Have
Experience in usage systems, Adept at building presentations, Attention-to-detail, Analytical skills, Ability to summarize information
What You'll Do.
Oversee work of scientists
Ensure scientific quality of data review
Ensure operational quality of data review
Ensure consistency of data review
Ensure standardization of data review
Share lessons learned
Collaborate with Study Physicians
Collaborate with Clinical Scientists
Collaborate with Project Scientists
Oversee process implementation
Oversee ongoing review of critical safety data
Support TRISARC staff
Ensure seamless clinical data review
Ensure complete clinical data review
Support TRISARC Directors
Support TRISARC Associate Directors
Manage efficiency metrics
Manage quality metrics
Manage performance of personnel
How You'll Work.
Team & Collaboration
Multidisciplinary teams; Key stakeholders
Communication Scope
Scientific communication
Full Job Description
**Job Title:** Associate Director, Clinical Trial Safety Scientist **Location:** Warsaw **Model:** Hybrid 3+2 **Introduction to role:** Join our dynamic team at the Trial Safety Review Center (TRISARC) in the Research and Development function of AstraZeneca. As an Associate Director, you will be a scientifically oriented manager overseeing the work of a group of Clinical Trial Scientists/Senior Scientists/Senior Analysts. Your role will be pivotal in ensuring the scientific and operational quality of data review done by TRISARC staff, consistency, standardization and lessons learned sharing. **Accountabilities:** Your responsibilities will include collaborating with Study Physicians and Clinical/Project Scientists, overseeing the process implementation and ongoing review of critical safety data, supporting and mentoring less experienced TRISARC staff, ensuring seamless and complete clinical data review, and supporting TRISARC Directors/Associate Directors in resourcing, training, goal-setting, efficiency and quality metrics settings and performance management of TRISARC personnel. **Essential Skills/Experience:** \- Advanced university degree in a medical/life science field \- Minimum 3 years of experience working in clinical research, pharmacovigilance and/or safety and clinical data review methodology \- In-depth understanding of the clinical study and drug development process and GCP/ICH guidelines \- Extensive knowledge of applicable regulations and guidelines, including SAE reporting requirements \- Strong, demonstrated abilities/skills in team leadership \- Proven stakeholder management skills and tracked record of leading initiatives \- Ability to manage change, risks, priorities and performance targets \- Excellent knowledge of spoken and written English - communication in a scientific environment \- Computer proficiency **Desirable Skills/Experience:** \- Experience in usage systems and tools supporting review of clinical data, for example: REACT, SENTRI, G
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