Associate Director, Evidence Project Management I, II

2 tygodni temu

Warszawa, Mazovia, Polska AstraZeneca Pełny etat

Description of Services
  1. Co-ordinate/manage timely contributions of AZ core/extended members
  2. Interface with key stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery
  3. Review protocol drafts and input operational perspectives/content into document and authoring team discussions
  4. Provide input into and/or quality review and hold accountability for the development of essential study level documents (e.g. ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
  5. Ensure all required External Service Providers (e.g. CROs) are engaged at the study level (including execution of relevant vendors contracts) and are performing to contracted goals, timelines and budget, as well as adequate oversight is documented
  6. Responsible for study budget management through the study lifecycle and for providing budget progress updates to Dir EPM /Sr Dir EPM including any financial risks and mitigation plans (as part of the ongoing study change control process)
  7. Maintain/report accurate cost forecasts throughout study, manage study spend within available budget & agreed tolerances
  8. Manage/oversee financial processes (PO's, invoicing, cost reconciliation etc.), may delegate as appropriate
  9. Responsible for setup of the study cost tracker
  10. Monitor study risks throughout delivery and oversee team in the development/implementation of mitigations and contingencies
  11. Oversee study/EAP level performance against agreed upon plans, milestones and key performance metrics, EAP exit strategy
  12. Identify and report quality issues that have occurred within the study, proactively communicate findings and corrective action plans (CAPA) to relevant stakeholders
  13. Oversee periodic TMF QC and responsible for review of relevant sections/documents in accordance with SOP/Wiki

Specifically in the EAP space if assigned to, in addition to above:

  1. Lead program planning, set up, implementation and delivery of EAP in collaboration with local/regional/global medical and market access teams
  2. Participate in operational governance activities related to agreed CRO strategic and operational governance principles
  3. Perform vendor oversight to ensure EAP delivery to time, cost and quality
  4. Collaborate with vendors to ensure the EAP operational aspects are effectively undertaken and that they have clear remits for delivery
  5. Manage resolution of program specific issues and escalations with internal and external stakeholders
Requirements

Essential:

  • Bachelor's degree required preferably in medical or biological science or equivalent by experience
  • Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area
  • Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools
  • Ability to effectively work with Clinical Research Organisations/External Providers
  • Ability to mentor, develop and educate staff
  • Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
  • Ability to look for and champion more efficient and effective methods/processes of delivering evidence studies focusing on key performance metrics around reliability, efficiency, cost and quality
  • Proven ability to interact widely and effectively within the company across regions, functions and cultures
  • Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
  • Strong strategic and critical thinking abilities
  • Strong organizational and problem-solving skills
  • Ability to manage competing priorities

Desirable:

  • Experience and knowledge within compliant management of Early Access Program
  • Advanced degree in medical or biological sciences or field associated with clinical research
  • Experience of incorporating digital health and patent centric strategies into clinical studies

Date Posted: 29-lut-2024

Closing Date: 30-mar-2024


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