Local Study Associate Director – BioPharma – 12 Month FTC

AstraZeneca UK

Location: Leicestershire

Job Type: Full time

Posted


Local Study Associate Director – BioPharma – 12 Month FTC

Location: Field based

Competitive Salary & Benefits!

At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us!

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines aligning with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP including relevant local regulations.

In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.

The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

What you’ll do

  • Has the overall responsibility for delivery on the study commitments within the country, including quality and compliance with study procedures to time and budget.
  • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely submission of documents for Health Research Authority approval in line with local regulations.
  • Ensures timely preparation of country financial Study Management Agreement and manages the study budget accurately in AZ clinical studies financial system by regular checks and quarterly attestations.
  • Ensures all country and site level trial essential documents required by ICH-GCP, are collected and maintained in line with AZ SOPs throughout the life of the trial.
  • Oversees, leads and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans, including performing co-monitoring visits with study CRAs. Reviews monitoring visit reports and pro-actively advices the monitor(s) on study related matters.

Essential Criteria

  • Excellent knowledge of ICH-GCP and relevant local regulations.
  • Capability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
  • Excellent team building and interpersonal skills.
  • Organisational need negotiation skills
  • Good ability to learn and to adapt to work with IT systems.
  • Ability to travel nationally as required.
  • Bachelors degree in related subject area, preferably in life science, or equivalent qualification.
  • Relevant experience in Development Operations (CRA, Sr CRA, LSL) or other related fields (Medical Affairs-led or Academic-led studies).

Desirable Criteria

  • Medical knowledge and ability to learn relevant AZ Therapeutic Areas.
  • Knowledge of the Drug Development Process.
  • Understanding of the Clinical Study Process including monitoring.
  • Understanding of the Study Drug Handling Process and the Data Management Process.

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. Always committed to lifelong learning, growth and development.

So, what’s next?

Complete your application before 29th February 2024

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Date Posted

22-lut-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.