Samenvatting
The Associate Director Clinical Processes & Solutions is responsible for leading and driving operational and scientific excellence through clinical process improvement across the portfolio. This includes but is not limited to actively driving updates of standard operating procedures, templates, guidance, and trainings. This position also serves as a clinical representative on cross-functional governance boards and development initiatives (including other line function initiatives).
This role will be based in Dublin, Ireland in a hybrid working approach.
About the Role
Your responsibilities will include;
- Drive the update of clinical document templates such as Clinical Trial Protocol, Investigator Brochure, Clinical Data Review, and Clinical Development Plan according to clinical guidance
- Participate and represent Clinical Development on important strategic cross-functional projects as defined by Clinical Development Leadership Team.
- Drive cross Clinical Development and Global Line Function alignment of processes as part of the deliverables of Clinical Development and drive implementation at the Unit level.
- Lead QA/SOP activities within Clinical Development, which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicability; performing collegial reviews of SOPs, templates and processes
- Can serve as a Lead SME or as an SME for clinical process-related work such as protocol deviations
- Drive best practices by identifying clinical training needs and development opportunities. Identify cross-functional issues, gaps and lead global process improvement work streams as applicable
- In collaboration with QA, responsible to implement quality initiatives as needed: inspection readiness, records tracking, support audits preparation and follow up.
- Drive efficiency and track performance against metrics
- From a people standpoint, work with the Clinical Development to make sure that Clinical Development Leadership is informed at all points about key issues and has access to information when needed
Minimum requirements
- Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master, PharmD, or PhD strongly preferred
- Strong understanding of Pharmaceutical Development processes
- ≥5 years technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia
- Thorough knowledge of Good Clinical Practice
- Strong scientific background in basic and clinical research
- Strong skills in leading and managing cross-functional projects with significant business impact.
- Excellent interpersonal and communication skills with influencing, negotiation and conflict resolution skills
- Excellent analytical, process-oriented and data driven mind-set.
- Act as change agent and actively generate and foster creativity and innovation in CD
- Strong project management skills
- Leadership presence with the ability to present and interact with senior management
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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