GERENTE DE PROJETOS CLÍNICOS ONCOLOGIA

Will lead Local Study Team(s) (LSTs) at the country level to deliver committed components of oncology clinical studies according to agreed resources, budget, and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP, as well as relevant local regulations.
In addition to leading LST(s), the Oncology Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.
The LSAD is responsible for ensuring that sites are identified, site qualifications performed, set up, initiated, monitored, closed, and documentation archived Accountabilities • 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 Study Start-up Manager(s), Contract Manager(s), CRA(s), CSA(s), for assigned study/studies.
• Leads and optimizes the performance of the Local Study Team(s) at the 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.
• Leads the site selection process by identifying potential sites/investigators with Feasibility Lead (and (acting) Site Engagement Lead- where applicable), erforming initial Site Quality Risk Assessment in collaboration with CRA, and conducting or overseeing 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 in collaboration with Clinical Research Associate Director as appropriate.
• Reviews or oversees the review of monitoring visit reports (as required and following AZ SOPs) and proactively advises 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.
• Is responsible for coordinating LST and specific meetings with the local medical affairs team through ECPLIPSE2.
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• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff, local (e.
., medical affairs) and global stakeholders.
• Is responsible for proactively sharing Reports study progress/update, risks, and mitigation plan 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 and set-up of recruitment vendor solutions.
• 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 coordinates regularly with National Coordinating 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 the 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 timely manner to maintain the eTMF “Inspection Ready”.
• Ensures that all study documents are ready for final archiving and completion of the 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/ies 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 the local Medical Affairs team on the study execution and delivery.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
• May act as Site Management & Monitoring Lead for the study.
Requirements.
● Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
● Fluent in English.
● Management people experience (can be indirect); ● Oncology knowledge.
● 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.
AstraZeneca offers an environment where you can work on one of the broadest and deepest Oncology pipelines in the industry.
This provides opportunities to engage with novel molecules at all development stages.
We challenge our thinking continuously to push our pipeline forward and shape the future of Oncology.
Our commitment to patients drives us to make bold moves that transform cancer treatment.
We foster a collaborative environment where diverse knowledge from across the business is leveraged to tackle tough medical challenges.
Empowered by our collective courage and curiosity, we take smart risks while learning from failures.
Join us at AstraZeneca where science meets innovation.
Ready to make a difference? 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 authorization and employment eligibility verification requirements.