AstraZeneca

AstraZeneca

Associate Director, Evidence Project Management

US - Gaithersburg - MD · Director

Sponsorship not specified$142k-$213kDetected 1 day ago
GCPProject ManagementIntellectual PropertyClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaboration

About the role

  • This person is responsible for leading a cross-functional AstraZeneca (AZ) study team and supervising the CRO study team as well as for providing the teams with direction and guidance to enable successful study and/or EAP delivery.
  • However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
  • Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Responsibilities

  • Partner with direct manager, ensuring provision of expertise and operational input into the programs(Governance interaction, study protocol, etc)
  • Collaborate with Dir EPM /Sr Dir EPM and provide adequate input to enable effective CRO selection
  • Work with externally managed/outsourced partners for studies planning and delivery
  • Mentor, coach and support the study team members.
  • Lead a cross-functional study team in accordance with EMPOWER to ensure study progress as planned and driving achievement of breakthroughs.
  • Co-ordinate/lead timely contributions of AZ core/extended members
  • Collaborate with key partners cross-functionally, and/or external partners, to identify, handle and resolve issues affecting study delivery
  • Review protocol drafts and input operational perspectives/content into document and authoring team discussions
  • Provide input into and/or quality review and hold accountability for the development of crucial study level documents (e.g. ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
  • Maintain/report accurate cost forecasts throughout study, lead study spend within available budget & agreed tolerances

Requirements

  • Ability to effectively work with Clinical Research Organizations/External Providers
  • 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
  • Persuasive communicator in English with a proven track record to work collaboratively in a multi-cultural environment
  • Experience and knowledge within compliance management of Early Access Program

Compensation

  • The annual base salary for this position ranges from $142,171-$213,256.

Benefits

  • 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
  • Lead program planning, set up, implementation and delivery of EAP in collaboration with local/regional/global medical and market access teams

Company info

  • 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)
  • Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work.

Visa & Work Authorization

  • Sponsor Oversight Plan, Description of Services)

This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.