Clinical Lead – Cell & Gene Therapy, Oncology
IQVIA
full-time
Posted on:
Location Type: Office
Location: São Paulo • 🇧🇷 Brazil
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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.
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical project plansclinical operations planrecruitment strategydata integrityproject managementcell and gene therapyoncology studiesCAR-T treatmentsGood Clinical Practice (GCP)International Conference on Harmonization (ICH)
Soft skills
communicationperformance assessmentorganizational skillsleadershipstrategic planningadaptabilitydirection providingobjective setting