Associate Study Start Up Manager, IQVIA Biotech
3 semanas atrás
Overview
At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech-tailored delivery model, we accelerate clinical development from early phase through global registrational studies.
Job TitleAssociate Study Start Up Manager, IQVIA Biotech
Responsibilities- Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
- Oversee Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects; develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan; resolve project-related issues; ensure collaboration across Regulatory & Site Activation and regions/countries to deliver the project scope in compliance with the RSU Management Plan.
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials while ensuring regulatory compliance.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and authorizations.
- Identify regulatory complexity and challenges; offer creative solutions to support bid processes and execution of the site activation plan. Assess regulatory landscape and contribute to regulatory intelligence for assigned studies and the wider company. Align maintenance of clinical study approvals, authorizations and contract/essential document reviews with Quality Management.
- Mentor and coach colleagues; ensure accurate completion and maintenance of internal systems (CTMS), databases, tracking tools, timelines and project plans. May develop long-standing relationships with IQVIA customers and deliver presentations or training as required.
- May participate in monthly study budget planning and reviews.
- Bachelor's Degree in a related field
- 3 years of clinical research experience, including 1 year in a leadership capacity; equivalent combination of education, training and experience acceptable
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Strong knowledge of medical terminology and regulations
- Broad knowledge of clinical research
- Strong knowledge of Microsoft Office and e-mail applications
- Effective communication, organizational, and interpersonal skills
- Effective presentation and leadership skills
- Ability to work independently and prioritize tasks; ability to delegate and manage multiple projects
- Attention to detail and ability to establish and maintain effective working relationships with coworkers, managers and clients
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. Learn more at
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