Local Study Associate Director

Do you have expertise in, and passion for, Clinical Study Site Management? Would you like to apply your expertise to impact Oncology Studies in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society!

Site Management & Monitoring delivers reliable, efficient, high quality study data to Oncology R&D and Biopharmaceuticals R&D. We work across approximately 40 countries, managing and monitoring activities focused on protecting patients, supporting investigators and ensuring reliable data is delivered. Our scope includes global interventional phase I-IV studies, local/regional interventional, early phase large and small molecule studies, NIS and ESR.

What you’ll do

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
• Leads and optimize the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• 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 delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
• Leads and optimize the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• 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 delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with AZ SOPs.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organizes regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plan on country study level proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads National Investigator meetings, in line with local codes, as required.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and AZ Procedural Documents.
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study/ides and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Essential for the Role

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (*).
• Minimum 3 years of experience in Development Operations (CRA, SCRA) or other related fields (Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Excellent project management skills, team building and interpersonal skills.
• Great organizational, verbal and written communication skills.
• Ability to prioritize and handle multiple tasks.
• Excellent attention to details.
• Knowledge of spoken and written English.
• Good negotiation skills and ability to learn and to adapt to work with IT systems.
• Able to travel nationally and internationally as required.
• Excellent verbal and written communication and presentation skills
• Demonstrates ability to work independently, as well as in a team environment
• Excellent interpersonal skills and proven ability to facilitate team building and teamwork
• Willingness to travel both domestically and internationally
• Demonstrates sound knowledge of GCP, AZ Procedural documents, as they pertain to study delivery systems and processes
• Proactively identifies risks and issues and possible solutions
• Demonstrates high standards and uses tactful persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships
• Develops knowledge of therapy area through experience and review of scientific literature, and demonstrates ability to learn new therapy areas
• Demonstrates ability to prepare and deliver study related training materials
• Ability to plan, coordinate, and facilitate internal and external meetings
• Demonstrates professionalism and mutual respect
• Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities

Desirables for the Role:

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring.
• Great understanding of the Study Drug Handling Process and the Data Management Process.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Integrity and high ethical standards.
• Good analytical and resource management skills.
• Excellent decision making and delegation skills.
• Good financial management skills.
• Basic change management and coaching skills.
• Ability in handling crisis situations.
• Good intercultural awareness.
• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

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

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn [https://www.linkedin.com/company/1603/>

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Date Posted

03-Jul-2024

Closing Date

09-Jul-2024Our 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.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.