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Associate Clinical Lead

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1316891

Descripción del trabajo

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 IQVIA 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 SOP’s, policies and practices.

RESPONSIBILITIES

  • 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.
  • May develop, provide input, 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) 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 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.
  • Support the delivery of 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.
  • Identify 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 clinical team members and planning/implementing appropriate corrective and preventative action plans.
  • May serve as clinical project contact with customer where applicable and agreed with the project leader.
  • Support drive for high performance and efficiency of the clinical team through CRA project objectives including the conduct of monitoring visits.
  • 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 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.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Broad protocol knowledge; therapeutic knowledge
  • Good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
  • Ability to understand customer needs and appropriately influence decision making
  • Ability to develop and deliver training materials to achieve clinical team understanding of project and enable effective delivery thereof
  • Basic understanding of project financials
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Ability to organize 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
  • Experience working productively in a pressurized environment, managing competing priorities and maintaining a positive outlook at work; handles criticism well and learns from it
  • Good 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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's degree in a health care or other scientific discipline and 3 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 occasional travel

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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