Associate Director, Clinical Trial Safety Scientist

Role Barcelona onsite

The Trial Safety Review Center (TRISARC) is a department in the Research and Development function of AstraZeneca. The primary remit of TRISARC is to review large amounts of medical (mainly safety) data flowing through the clinical trial environment to ensure patient data is complete and medically accurate thus allowing study physicians and clinical/project scientists to interpret medical/ safety data efficiently. Associate Director Scientist must be a science-driven individual experienced in review of clinical data. He/she will work in close collaboration with the Study Physicians and Clinical/Project Scientists providing them consolidated data supporting high quality medical/ safety evaluation. The role will have a focus on late-stage clinical trials within the program/ molecule/ indication level as well as on early phases according to the business needs. The role can be associated with a set of responsibilities of TRISARCs project leader and/or TRISARCs program/ molecule/ indication leader.

Typical Accountabilities

Collaborate with Study Physician and/or Clinical/Project Scientist and other study team members if applicable providing scientific and operational input as well as oversight of TRISARC team dedicated to study start-up maintenance and closure activities and give consistent program/molecule/indication level input into generation of the relevant documents and tools configurations

Oversee the process implementation and ongoing review and querying of critical clinical/ safety data to ensure scientific quality and standardization on a program/ molecule/ indication level

Ensure seamless and complete clinical data review

May support TRISARC scientists in day-to-day handling and querying of clinical/ safety data within assigned projects and will review the data for medical completeness scientific accuracy and coding consistency

Ensure effective cross-functional collaboration between TRISARC staff and all stakeholders engaged in clinical/ safety data review on a program/molecule/indication level

Ensure feedback collection lessons learned sharing and transfer of learnings between studies to support high scientific and operational quality and standardization within program/molecule/indication

Support TRISARC Director on a program/molecule/indication level to ensure scientific and operational standards implementation for clinical/safety data review

Report and escalate to TRISARC Director progress/issues and risks on assigned program/molecule/indication level

Support TRISARC Senior Director Directors and/or Associate Directors in resourcing training goal setting efficiency and quality metrics settings and performance management of TRISARC personnel on a program/molecule/indication level

Assist TRISARC Directors/Associate Directors with recruiting and retaining talent including building effective teams

Support TRISARC Senior Director Directors/Associate Directors in alignment with stakeholders and important functions involved in handling and interpretation of clinical/safety data

Support TRISARC Senior Director Directors/ Associate Directors in building and implementing of the TRISARCs strategy focused on constant improvement of the processes tools the scope and ways of working; being responsible for the delivery of selected strategic goals leading or co-leading of strategic initiatives Act as a trailblazer in the clinical projects new for TRISARC from the therapeutic area/ indication/ molecule perspective as well as the new scope and new tools & associated processes perspective

Act as role model of TRISARC project leader/ project expert either as the project Primary Point of Contact (POC) and/or clinical/ safety data reviewer in the studies of high complexity and importance for AstraZeneca

Project subject matter expert for any topic related to handling of medical/ safety data such as review for medical completeness medical accuracy and coding consistency

Mentor and trainer for more junior staff to ensure consistent processes and efficient review of critical medical/ safety data across studies within the same molecule/program/indication contributing to development of onboarding and mentoring processes in the department

Lead quality of own deliverables and oversee quality of more junior staff by performing regular quality checks on study level

Education Qualifications Skills and Experience

Essential

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 or equivalent combination of scientific research activities

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

Proven project management capabilities; ability to manage change risks priorities and performance targets; showing excellent time management skills and ability to multi-task in a high-volume environment with shifting and/or competing priorities

Solving complex diverse multifactorial problems; managing change and uncertainty - for self and teams; supervising others work and providing support; setting own and team objectives aligning with business objectives/strategy

Supporting departmental / functional direction and articulating opinions and ideas

Managing/negotiating diverse/conflicting stakeholder interests; multidisciplinary communications and two-way influencing; presenting and collaborating securing buy-in on complex problems with diverse audiences

Excellent knowledge of spoken and written English - communication in a scientific environment; computer proficiency

Creativity innovation and results orientation; presenting AZ Values and Behaviours

Desirable

Experience in usage of systems and tools supporting review of clinical data for example: REACT SENTRI GPR J-review Rave; extensive experience in remote review of patient-level clinical data including clinical data querying and MedDRA coding review

Adept at building presentations and presenting scientific results to multidisciplinary teams and key stakeholders

Strong attention to detail analytical skills and ability to concisely summarize large amounts of complex information in the scientific environment

Ability to adapt to new IT solutions develop advanced computer skills to increase efficiency in day-to-day tasks

Date Posted

Closing Date

AstraZeneca 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.