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Associate Director Study Leader, Early Clinical

Gaithersburg, Maryland or UK
Competitive Salary and Benefits
Closing date
Jul 1, 2022

Job Details

Would you like have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then AstraZeneca may be right for you.

About AstraZeneca

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us. A place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take calculated risks that write the next chapter for our pipeline and Oncology team.

We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early stage cancer trials in the industry, we are getting closer to finding cures every day.

It’s our unique people-first approach that keeps us grounded and inspired to improve outcomes for all. Listening to our patients to evolve with their needs and tailor their medicines.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

What you’ll do

The Associate Director Study Leader, Early Oncology Clinical is responsible for the delivery of clinical studies including quality, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. Provides matrix management of functional area representatives to cross functional clinical study teams. Duties include:

  • Leads the delivery of the clinical study from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards.
  • May convene and lead the cross functional study team(s) for Early Oncology Clinical studies based on delivery model
  • Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative
  • Contribute to preparation and delivery of study documents (e.g. Protocols/amendments, Informed Consent Form (ICF) documents detailing study delivery data management activities, etc.)
  • Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment
  • Leads study recruitment and data delivery to agreed timelines and targets
  • Implement agreed study level process and technology for Early Oncology clinical studies
  • Lead to the agreed study timelines, budget, and resource and ensure the update of appropriate systems
  • Accountable for the quality of study planning information into relevant planning systems
  • Guide the study team in the development of outsourcing specifications and vendor selection
  • May handle the vendor(s) throughout the life of assigned clinical trial(s) based on delivery model
  • Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
  • Lead and conduct investigator meetings and other study related meetings
  • Identify and communicate resource gaps for assigned studies
  • Communicate study level reports and status updates for Early Oncology clinical studies
  • Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • Oversee the submission of trial-related and essential documents to the Trial Master File, maintenance and final closeout of TMF
  • Ensure sponsor oversight throughout the life of the study
  • Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
  • Responsible for study level reporting of progress, risks and issues
  • Provision to procurement clear specifications for study specific outsourcing
  • Review and operational approval of study specific contracts or work orders

Required Experience, Skills, and Qualifications

  • Bachelor’s degree in related field, preferably in medical or biological science
  • Minimum of 5 -7 years progressive experience in clinical research, with at least 3 years of global study leadership or equivalent
  • Comprehensive knowledge of the clinical and pharmaceutical drug development process
  • Excellent knowledge of ICH-GCP principles
  • Extensive and shown experience in driving operational delivery to timelines, cost and quality
  • Shown experience leading delivery through internal and external organizations
  • Experience and strength in working and leading in matrix teams
  • Strong collaborative communications skills including the ability to engage with a diverse client base and lead through conflict
  • Proven ability in problem solving and issues management that is solution focused
  • Experience in providing clear requirements for external contracts
  • Experience in selection of external providers and development/review of contracts
  • Proven oversight of external providers
  • Experience of early phase oncology clinical delivery

Desired requirements

  • Higher degree e.g. PhD, MSc, MPhil
  • Program management qualification (e.g. MBA, PRINCE2, PMP)
  • Experience in variety of academic/CRO/Sponsor organisations and countries

Why AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next:

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.



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