Associate Clinical Lead Director
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 IQVIA solutions to drive operational excellence particularly in respect to subject/patient recruitment and ontime 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 optimising 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.
- May contribute to the development of the project delivery strategy for Request for Proposals (RFPs).
- Participate in bid defense preparations. Lead the Clinical delivery strategy at bid defense presentations in partnership with Project Leader Business Development for large, complex, multi-region studies. Understand the overall project strategy and translate the agreed upon clinical approach to a successful practical delivery model.
- 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 maximise 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 maximise 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.
- Collaborate with the project leader in forecasting and identifying opportunities to accelerate activities to bring
- Site Management revenue forward. Ability to assess impact of project events which will have impact on financial performance.
- 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.
- Participate in, champion and adopt function and/or corporate initiatives, changes and/or special project assignments; act as a client liaison, departmental cross-functional liaison and/or change agent.
- Provide input to line managers of their project team members’ performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Broad protocol knowledge; therapeutic knowledge
- Strong understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
- Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA services &/or solutions
- Ability to understand customer needs and appropriately influence decision making
- Strong understanding of other company functions and their inter-relationship to achieve project delivery
- Good knowledge of Project management practices and terminology
- Ability to develop and deliver training materials to achieve clinical team understanding of project and enable effective delivery thereof
- Good understanding of project financials
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
- Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances; manages time effectively
- Excellent communication and presentation skills, including good command of English language
- Demonstrated high proficiency in using systems and technology to achieve work objectives
- Proven ability at analyzing data and information to derive conclusions and drive sound decision making
- Experience working productively in a pressurized environment, managing competing priorities and maintaining a positive outlook at work; handles criticism well and learns from it
- Excellent customer service skills and demonstrated ability to understand customer needs and appropriately influence decision making
- Strong software and computer skills, including MS Office applications
- Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving
- Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in a health care or other scientific discipline with 10 years clinical research/monitoring experience; or equivalent combination of education, training and experience.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- May require occasional travel
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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