Clinical Lead - Cell & Gene Therapy (Oncolgy)

IQVIA; Ciudad de México; Presencial; MXN 1,115,000 - 1,673,000; Jornada completa

Descripción de la vacante

A leading global provider of clinical research services in Ciudad de México is seeking a Clinical Lead to guide the clinical team in delivering projects successfully while ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in clinical research, particularly in cell and gene therapy, and must excel in project management. The role necessitates strong planning and organization skills to facilitate effective clinical operations.

Formación

• 7 years of clinical research/monitoring experience.
• Minimum 3 years in a leadership role.

Responsabilidades

• Lead the clinical delivery strategy for medium size studies.
• Develop and maintain clinical project plans.
• Ensure compliance with standard processes and policies.

Conocimientos

In-depth knowledge of GCP and ICH guidelines

Knowledge of Project Management practices

Experience in cell and gene therapy

Ability to plan and organize clinical resources

Educación

Bachelor's degree in health care or scientific discipline

Descripción del empleo

Job Overview

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.

Tasks & Responsibilities

• 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.

Essential Requirements

• 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.
• Knowledge of Project Management practices and terminology.
• Candidates must have prior experience in cell and gene therapy, including oncology studies involving CAR-T treatments (mandatory).
• 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.
• Bachelor's degree in a health care or other scientific discipline with 7 years clinical research/monitoring experience; or equivalent combination of education, training and experience.
• At least 3 years’ experience in the role.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com