IQVIA Clinical Operations Lead/Senior Clinical Operations Lead, Real World Evidence in Parsippany, New Jersey
Independently direct the execution of Real World studies by applying clinical research experience and decision making skills to proactively set goals and tangible expectations for project team members. The Site Management 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 Standard Operating Procedures (SOPs), policies and practices.
Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed Start Up strategy. May implement and maintain the Regulatory Start Up Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
Manage the operational aspects of projects to achieve “right subjects” and “right data” to meet our contractual requirements.
May participate in bid defense preparations. May attend and present at bid defense presentations in partnership with business development and senior project leader as needed
Ensure collaboration across Site Management Leads, including communication with regions and countries, to successfully deliver the agreed project scope; coach members of the team to ensure timely delivery of projects
Real Word Evidence resource request review and alignment from project award and during entire duration of the project.
Develop and maintain clinical project plans, including but not limited to i. e. Clinical operations plan, Regulatory Start Up Management 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) of assigned portion of clinical studies, or may be fully accountable for less complex studies 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 or support ensuring, on less complex studies, that 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 Site Management 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 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 Site Managers/Clinical Research Associates (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 raised by Site Management 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 through Site Manager/Clinical Research Associate (CRA) project objectives including the conduct of monitoring visits.
Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Support the project leader and accountable as functional lead, in ensuring the financial success of the project.
Ensure accurate completion and maintenance of internal systems (with emphasis on Clinical Trial Management System), databases, tracking tools, timelines and project plans with project specific information.
Identify changes in scope and support project leader in completion of the change control process.
Identify lessons learned and implement best practices.
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.
May Conduct co-monitoring and/or assessment visits to ensure the study is being conducted in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements.
May mentor and coach colleagues as required and provide technical guidance both within and outside the project. May act as Global Site Management Lead within a project.
Bachelor's Degree Health care or other scientific discipline or educational equivalent Req
5 yrs of clinical trials experience Req Or
Equivalent combination of education, training and experience Req
Skill in understanding and executing complex study designs.
Ability to understand customer needs and appropriately influence decision making
Basic 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
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
Strong communication and presentation skills, including good command of English language
Demonstrated 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
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
Ability to manage competing priorities and ensure on-time, high quality delivery of project tasks/responsibilities.
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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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