Technical Requirements:
Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the Client’s internal and CRO/Phase 1 Unit teams.
• If a Clinical Pharmacology study, ensure selection of the optimal Phase I Unit within or outside the SPI framework depending on the specialist need of the study.
• At the study kick-off meeting, articulate study scope, goals, and expectations of Client to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning.
• Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making. Such as for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings and final CSR.
• Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments. Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit.
• Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.
• Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables, with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget.
• Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.
• Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence. Findings, including mitigation plans, to be discussed with the CRO and communicated to all appropriate internal and external stakeholders.
• Become familiar with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.
• Understand, manage, track and ensure accuracy of study budgets in Client’s systems, including the forecast and accrual information.
• For assigned studies, work closely with the respective Program Delivery Leads, and other team members and stakeholders as required, to serve as the key internal clinical operations contact whilst keeping the PDL updated on all study issues.
• Closely cooperate with OC&SP and, if applicable, relevant committees/governance bodies and/or CQA regarding the performance and quality of work received from the CROs/Phase 1 Units and other vendors.
• Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols, protocol amendments, and other relevant study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope.
• Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate).
• Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs).
• Support Data cleaning and data evaluation meetings (DEM) and Results Interpretation Meetings (RIMs)
• Support conduct of Data Monitoring Committee (DMC)/Safety Monitoring Committee (SMC) review meetings.
• Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members.
• Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members.
• Ensure quality and adherence to the relevant Client’s SOPs, GCP, regulatory guidelines and working practices.
• Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
• Asia Specific – support any Regulatory Authority consultation activities.sm
• Provide study specific training for internal and external (i.e. CRO, vendors, investigators) team members.
• Identify issues/gaps in processes and interfaces with other groups and departments and
contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs.
• Visit investigational sites and Phase 1 Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrollment, when needed for assigned clinical studies.
• A Senior CPM is expected to mentor other colleagues, present clinical trial related information internally or to an external audience as appropriate.
• A Senior CPM may be assigned to more complex studies and/or those with high visibility such as pivotal trials or challenging POC trials, or multiple studies running in parallel.
• Perform other tasks as deemed necessary by the Company. –