Skip to main content
Search roles

Global Study Leader, Early Oncology Clinical

Location Royston, England, United Kingdom Oss, North Brabant, Netherlands Gaithersburg, Maryland, United States Waltham, Massachusetts, United States Cambridge, England, United Kingdom Job ID R-084729 Date posted 06/17/2020

At AstraZeneca every one of our employees makes a difference to patient lives every day. Each, and every one of us believes that science has the ability to change lives and that to

deliver this takes many people with differing skill sets. When we deliver a life-changing

medicine, that success comes from the combined efforts of all of our people.

The Global 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. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.

Typical Accountabilities

  • Leads the delivery of the clinical study from concept to final CSR and through to study closed and archived 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
  • Implement agreed study level process and technology for Early Oncology clinical studies
  • Manage 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 manage 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

Education, Qualifications, Skills and Experience

Essential

  • Bachelor’s degree in related subject area, preferably in medical or biological science
  • Minimum of 5 years progressive experience in clinical research, with at least 3 years of clinical development project management experience or equivalent
  • Comprehensive knowledge of the clinical and pharmaceutical drug development process
  • Excellent knowledge of ICH-GCP principles
  • Extensive and proven experience in driving operational delivery to timelines, cost and quality
  • Proven 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 manage 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

Desirable

  • 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
  • Experience of early phase oncology clinical delivery

Next steps? Apply now!!



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 authorisation and employment eligibility verification requirements.

We’ll keep you up to date

Sign up to be the first to receive job updates.

Interested InSearch for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.