Associate Clinical Lead Director - CAR-T and Cell Gene Therapy
New
I
IQVIAClinical Research
United StatesFull-TimeDirector
Salary106,100 - 295,500 USD per year
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Job Details
- Languages
- English
- Experience
- 10 years clinical research/monitoring experience
- Required Skills
- Project ManagementFinancial ManagementMicrosoft OfficeStakeholder managementRisk Management
Requirements
- Bachelor's Degree in healthcare or other scientific discipline.
- 10 years of clinical research/monitoring experience or equivalent combination of education and training.
- In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Consolidated knowledge of project management practices and terminology.
- Strong understanding of clinical trial conduct and regulatory requirements.
- High proficiency in using systems and technology to achieve work objectives.
- Solid knowledge of project finances.
- Strong written and verbal communication skills, including a good command of the English language.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
- Strong organizational, time management, and prioritization skills.
- Ability to establish and maintain effective working relationships and work across geographies.
Responsibilities
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements, and internal SOPs.
- Accountable for meeting project recruitment targets and implementing appropriate recruitment strategies.
- Contribute to the development of project risk mitigation plans and manage clinical risks throughout the project lifecycle.
- Manage clinical aspects of project finances, including Estimate at Completion (EAC) and identifying out-of-scope work.
- Identify and manage internal and external clinical stakeholders through effective communication and resolution management.
- Lead and manage the clinical team at the project level, including resourcing, talent planning, and providing training.
- Contribute to clinical delivery strategy for business proposals and participate in bid defense meetings.
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