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CPM Lead

Location: 

Shanghai, Shanghai, China

Job Function:  Clinical Development
Job ID:  59642

      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 UCB internal and CRO teams.

      Articulate study scope, goals and expectations of UCB to the CRO at kick-off and ensure CRO is informed about any relevant sponsor information that may impact the management of the trial throughout the conduct of the trial.

      Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the CRO.

      Review and challenge CRO's strategy and plans, if appropriate.

      Supervise study conduct by regularly reviewing CRO performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/or impact on 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.

      Familiarize 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, including the forecast and accrual information.

      Work closely with the COL (Clinical Operations Lead), Clinical Project Director (CPD), other team members and stakeholders as required and serve as the internal key contact for their assigned studies.

      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 and other vendors.

      Drive the creation of protocol Summaries (including particular emphasis on operational expertise) and consolidate contributions of all team members (may include CRO experts).

      Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols and protocol amendments and 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.

      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 UCB 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.

      Provide study specific training for internal (i.e. UCB) 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.

      Travel including overnight stays- possibly global - required.

      A Senior CPM is expected to mentor other colleagues, present clinical trial related information internally or to an external audience and/or contribute to publications 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.


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