IQVIA Associate Clinical Lead Director/ Clinical Lead Director, various locations in Europe and Africa in Antwerpen, Belgium
Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
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.
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 (may include mega 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.
Assist the Project leader in recognizing systemic issues at a program or portfolio level. Identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices within the respective clinical teams. Support the project leader in the address of escalation items with the customer.
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.
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
Strong understanding of the competitive environment and how to communicate/demonstrate value through IQVIA services &/or solutions
Proven ability to understand customer needs and appropriately influence decision making
Strong understanding of other company functions and their inter-relationship to achieve project delivery
Strong 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
Strong 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 management skills and demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand broader impacts beyond immediate project on the overall program/portfolio and customer relationship
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 colleaguesMINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a health care or other scientific discipline with 12 years clinical research/monitoring experience; or equivalent combination of education, training and experience.PHYSICAL REQUIREMENTS
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 frequent travel
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
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