Description PURPOSE Clinical Leadership is focused on the delivery and quality of the contracted Clinical services within a project to achieve customer satisfaction. Focus is on leveraging clinical operations and therapeutic expertise along with the diverse QuintilesIMS solutions to drive operational excellence particularly in respect to subject/patient recruitment and on-time high quality data collection. The Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the 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.
Accountable for ensuring the “right subjects” and “right data” to meet our contractual requirements.
Participate in bid defense preparations. Attend bid defense presentations and lead the clinical delivery strategy for medium size and multiple country/region studies, in partnership with business development and senior project leader as needed.
Develop and maintain clinical project plans, including but not limited to clinical operations plan, recruitment and retention strategy plan, etc. to be incorporated into the integrated study management plan/project management plan.
Accountable for the clinical delivery (subject recruitment, site management, data integrity) per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Partner with the project leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy and approach. Effectively communicate and assess performance against these agreed objectives.
Ensure all appropriate subject/patient recruitment strategies are in place at the outset of the study to maximize subject/patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or digital offerings being explored and deployed.
Ensure all processes and tools are available to maximize clinical team’s ability to monitor and secure patient recruitment to the monitoring team from the outset of the study including, but not limited to a clear recruitment strategy plan, the subject/patient pathway materials and clearly defined contingency plans with agreed trigger points for deployment. Throughout the study these strategies and materials should be kept under constant review and updated in response to progress on the study to ensure clear understanding by all parties (internal and external) of expectations throughout the recruitment period; and inspire customer confidence in a clear and enforced action plan and thereby ensure successful delivery to customer satisfaction.
Monitor clinical progress against contract and prepare/present project information proactively to all stakeholders internally and externally as required.
Deliver the project/program according to the quality management plan. Guide CRAs and advise on critical specific study issues.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Manage risks (positive and negative) which could impact on the clinical delivery of the project and determine contingencies. Partner with functional leaders in problem solving and resolution efforts.
Achieve project quality by identifying quality risks and issues, responding to issues which impact the clinical delivery, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
Serve as clinical project contact with customer where applicable and agreed with the project leader.
Drive for high performance and efficiency of the clinical team to support financial success of the project.
Support the project leader in ensuring the financial success of the project.
Identify changes in scope and support project leader in completion of the change control process.
Identify and communicate lessons learned and implement best practices to promote continuous improvement.
Adopt corporate initiatives and changes and serve as a change advocate when necessary.
Provide input to line managers of their project team members’ performance relative to project tasks. Support staff
Ciudad: buenos aires
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