Centralized Monitoring Lead (R1053920) in Shanghai, China bei IQVIA™

Datum der Veröffentlichung 5/28/2019


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Provides leadership of the CMS team, in partnership with project and clinical lead, and in collaboration with other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our SOPs, policies and practices. The CML has particular focus on leading/advising the centralized team (CM & CAS) towards solutions to clinical risks identified, and facilitating successful implementation of those strategies to address the issues.
• Provide oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operation Plan (COP) from Applications/ Analytics/ Therapeutics/ Quality perspective.
• Perform functional lead responsibilities for assigned project deliverables for specific customers or projects/specified.
• Independently manage assigned studies.
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Contribute and/or oversee to the development and use of study management plans, specific tools and document templates and/or other study specific plans to evaluate the quality and integrity of the study; including complete and accurate documentation so that the project is audit ready.
• Support project management team to develop monitoring strategy including monitoring triggers/thresholds.
• Manage and monitor operational insight of the assigned project(s) and complete/oversee the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).
• Contribute to developing the study specific analytics strategy and work on developing advanced analytics.
• Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections
• Identify the value adds from the medical review & remote monitoring in the study and provide the inputs to relevant stakeholders.
• Manage project resources (CRAs/ /CTAs/Centralized monitoring team)
• Oversee the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).
• Take up customer lead activities to provides oversight of unblinded monitoring procedures on a study.
• Act as mentor or coach for junior CMS staff.
• Support the Centralized Monitoring Advisor/Centralized Monitoring Manager in periodic review of Centralized monitoring trainings and/or identify the training needs of the team and provide inputs whenever required.
• Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan
• Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk
• Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit)

Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed
• Review of the Study Central Monitoring Plan
• Act as point of contact for assigned deliverables for specific customer or projects/specified
• Monitor operational triggers/Key Data Points/data trends and monitor their compliance check by performing regular Quality Check.
• Mentor projects/ initiatives on industry best practices
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Establish and maintain effective project/ site level communications with relevant stakeholders
• Maintain relevant project documents
• Collaborating with peers and promoting cross functional synergies.
• Project Oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines
• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles
• Ensure complete and accurate documentation of all the study specific tools and templates and keep the project Audit ready. Process Quality and audit initiatives
• Identify impacted areas, provide root cause and implementation of corrective and preventive action
• Participate in (study) team meetings and implement action items
• Create and maintain relevant project documents/ trackers
• Ensure accurate completion and maintenance of internal systems, tracking tools and timelines
• Collaborating with peers and promoting cross functional synergies.
• Coordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles
• Coaching and mentoring of Subject Matter Expert (SME)

• Bachelor’s degree in clinical, life sciences, mathematical sciences, or related field, nursing qualification or allied medical degree with minimum of 5 years or
• Medical degree with a minimum 4 years of clinical trial experience or equivalent combination of education, training and experience.

• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require working in shifts (as applicable)

Job ID: R1053920