Global Study Lead
Posted on :
28-07-2024
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1 Vacancy
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Job Description
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About the job
Responsibilities
- Lead and coordinate a cross-functional study team of experts in accordance with STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
- Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
- For outsourced studies, be the primary AZ point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations)
- Provide input into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs
- Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented
- Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
- Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations
- Identify and report quality issues that have occurred within the study in accordance with relevant AZ SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
- Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times
- Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency)
- The GSL is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process)
- Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines; GSL is the primary Study Management & Operations (SMO) point-of-contact in the event of an audit or inspection
- Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues
- Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
Employment Type
Full-time
Department / Functional Area
Key Skills
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