- Assist the Study Management Director/Associate Director with the operational planning for upcoming clinical studies to interface with other Clinical Operation and the TA functions, as required
- 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 progresses as planned and drives achievement of milestones according to timelines, budget and quality standards
- Contribute in vendor/external service provider (ESP) selection activities at the study level, including bid defense, and lead operational oversight at the study level to ensure appropriate control over the vendor identification and selection
- Collaborate with other Clinical Operation functions to establish strategies and identify synergies aimed at increasing efficiency of study teams (core and extended)
- 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 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 ESPs (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 through planning & control activities
- Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan or 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, R&D Quality Assurance staff, functional line management, etc.)
- Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, which includes ensuring availability of TMF plan and Essential Document List (EDL) and QC activities are performed on an ongoing basis to ensure completeness
- Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency)
- 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 always inspection-ready, according to ICH GCP, AZ SOP and relevant policies/guidelines and becomes the primary Study Management 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
- For China-led development programs, lead the development, baselining and maintenance of realistic, up-to-date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as CTMS, PLANIT and ACCORD)
- Provide clinical operation inputs into strategy, early planning and submission activities in involved program; for example, input into study feasibility, study specifications, vendor/partner contracts and essential documents as needed
- Provide guidance, training, expert input, and support to less experienced GSL colleagues on an ongoing basis
- Work on non-drug project work such as study management representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
