Associate Study Start-Up Manager
New
I
IQVIAClinical research
United StatesFull-TimeMiddle
Salary60,300 - 157,100 USD per year
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Job Details
- Experience
- 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role.
- Required Skills
- GCP
Requirements
- Bachelor’s degree in life sciences or a related field.
- 7 years of relevant experience in a scientific or clinical environment, including demonstrable international experience.
- Thorough understanding of the regulated clinical-trial environment and drug-development process.
- Strong knowledge of and ability to apply GCP, ICH guidelines, and applicable regulatory guidelines.
- Good regulatory and/or technical writing skills.
- Demonstrated proficiency using systems and technology to achieve work objectives.
- Strong negotiation and communication skills, including the ability to challenge.
- Good leadership skills, including the ability to motivate, coach, and mentor.
- Strong organizational and planning skills, with the ability to manage multiple projects and competing priorities.
- Excellent understanding of study financial management.
- Ability to exercise independent judgment and take calculated risks when making decisions.
- Good presentation skills and ability to establish effective working relationships with coworkers, managers, and sponsors.
Responsibilities
- Oversee site activation, pre-award activities, and maintenance for assigned projects in line with the agreed strategy and timelines.
- Develop and maintain management plans aligned with the scope of work and project plan, resolving project-related issues as needed.
- Coordinate Regulatory and Site Activation collaboration across regions and countries to deliver project scope in compliance with the management plan.
- Create or review technical and administrative documentation supporting business development, study initiation, and maintenance.
- Provide regulatory and technical scientific support for clinical trial business development, initiation, and maintenance.
- Guide multi-regional and multi-protocol programs during start-up and maintenance as part of the study management team.
- Determine regulatory strategies and submission requirements, and identify regulatory challenges and practical solutions.
- Assess regulatory landscapes and contribute regulatory intelligence for assigned studies.
- Work with Quality Management to maintain appropriate quality standards during site activation or maintenance.
- Maintain project information in internal systems, especially CTMS, databases, tracking tools, timelines, and project plans.
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