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Posted date: Mar. 20, 2019
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
We’re inspired by the things that seem impossible. Here, we see the impact of our collective ideas and expertise, and the power of science to deliver them.
To lead, from an operational / study delivery perspective, the planning, execution and publication of AstraZeneca-sponsored evidence generation studies and the review and support of Externally Sponsored Scientific Research studies (ESR), as well as the setup of Early Access Programs (EAP) and Foreign Medication programs (FMP) within agreed time, budget (cost and resources) and quality, to increase patient’s quality of life.
• To cooperate closely with GMA and Europe Region for the conduct of evidence generation studies.
• To work actively towards achieving good personal relationships with applicable internal stakeholders such as Medical Managers, Medical Leads, Medical Director, MedEx, Pharmacovigilance, Compliance, Market Access, Quality, GMA, GREG and Global Publications teams.
• To work actively towards achieving good personal relationships with external key stakeholders such as principal investigators of AstraZeneca-sponsored or externally sponsored evidence generation studies, to identify and resolve operational issues, facilitate study start-up activities, and ensure study delivery.
• To work in close collaboration with the support team at MEDICLIN, ensuring a fluent and open communication during the whole governance process.
• To contribute to the planning of Evidence Generation programs with the therapeutic areas, GMA and Europe Region, from an operational perspective.
• To ensure the supply of approved study materials to principal investigators or third parties (such as CRO´s).
• To act as the person of reference for all matters related to evidence generation studies assigned to them.
• To ensure that all aspects reflected in study contracts (with sites, investigators, CROs or any other third parties) are fulfilled and complied with, particularly in matters related to adherence to budget and delivery of reports and publications.
• To monitor study conduct and progress to proactively identify and resolve issues which may impact delivery of the study to the necessary quality, timelines or budget objectives.
• To build and keeps updated a database of investigators and sites in Spain, for future study/trials purposes.
• To collaborate with local MSLs in evidence generation study support.
• To contribute to set-up of Early Access Programs (EAP) and Foreign Medication programs (FMP), defining appropriate tracking tools, workflow and distribution of responsibilities between different stakeholders.
• To ensure that all job-related activities comply with relevant applicable AZ Procedural Documents, international guidelines such as ICH/GCP and relevant local legislation.
• To ensure that evidence generation studies meet quality standards, follow internal SOPs for AZ-sponsored and ESR studies and are conducted with proper adherence to budget, agreed timelines and productivity targets, including:
o Forecast and day-to-day management of study timelines, budget and materials; development of detailed study level plans, tracking tools, status reports and timely delivery of data to required quality.
o Ensuring that studies are registered in the appropriate systems (Evidence Connect, ESROS, InvestigAZ) and these are used and kept up to date.
o Planning and co-leading National Investigator meetings, in line with local codes, as required.
o Timely submission of application /documents to EC/IRB at start up and for the duration of the study.
o Collection and verification for correctness of all country and site level trial essential documents required by ICH-GCP prior to setting sites ready to enrol, and in line with AZ SOPs.
o Proactive identification of risks and facilitation of complex study problems and issues resolution.
o Development and management of local recruitment and contingency risk plans.
• To act as the reference person for AZ-sponsored or ESR studies in case of local audits and regulatory inspections, in cooperation with QA and Medical Affairs teams.
• To ensure compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Minimum Requirements – Education and Experience
• University degree in biological science or healthcare-related field.
• Excellent knowledge of spoken and written English (C1).
• Minimum 3 years of experience in Clinical Operations, Medical Affairs-led observational studies or Academic-led clinical studies.
• Knowledge of the pharmaceutical industry and especially of Medical Affairs departments and their responsibilities.
• Excellent project management skills, including budgetary and resource planning.
• Very good knowledge of clinical study and drug development processes, GCP/ICH guidelines and local applicable regulations.
• Proven ability to lead and motivate cross-functional teams to deliver evidence generation studies according to or ahead of time plan, budget and with required quality
• Excellent team building and interpersonal skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent organisational skills.
• Excellent attention to details.
• Good ability to learn and to adapt to work with IT systems.
• Open to periods of traveling, including national and international trips
• Good medical knowledge and ability to learn matters related to the relevant AZ Therapeutic Areas.
• Experience in studies of at least two phases (phase I-IV) of clinical development, or at least two types of study designs (e.g. interventional, non-interventional, prospective, retrospective, with databases).
• Good understanding of the Drug Development Process.
• Good decision making and delegation skills.
• Basic change management skills.
• Basic coaching skills.
• Basic ability in handling crisis situations.
• Good intercultural awareness.
• Good analytical skills.
• Good negotiation skills.
• Good resource and financial management skills.
4. FUNCTIONAL RELATIONSHIPS
• Spain Medical Director and Therapeutic Area Leads.
• Line manager (Medical Evidence Generation Lead)
• Spain Medical Managers and Medical Scientific Liaisons.
• Market Access Managers.
• QA, Pharmacovigilance, MedEx, Nominated Signatory and Compliance teams.
• MEORT, GREG and publications teams.
• Spain MC Clinical Research representatives: Clinical Research Head, monitors (Sr CRAs, CRAs) and SDAs
• Clinical Research Leadership team.
• Regulatory Affairs Managers.
• Principal Investigators of AstraZeneca-sponsored evidence generation studies and ESR´s.
• Investigators and Study Site personnel as per need.
• IEC, IRBs
• CRO´s and other vendors.
- Communication with impact
- Cross-functional Collaboration
- Stakeholder engagement
Medical standards & quality:Compliance
Business acumen :
- Managing Performance
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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