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Study Management Coordinator
1 week ago
The Site Activation Manager will oversee the execution of site activation and maintenance activities for selected studies or multi-protocol programs. This includes developing and implementing management plans, collaborating with regulatory and site activation teams, and preparing and reviewing technical and administrative documentation.
Key Responsibilities:
- Develop and implement management plans in accordance with scope of work and project plans, resolving project-related issues as needed.
- Collaborate with regulatory and site activation teams to ensure seamless delivery of project scope in compliance with RSU management plans.
- Prepare and review technical and administrative documentation to support business development and study initiation/maintenance, providing specialist regulatory and technical scientific support as required.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations and review/negotiation of contracts and essential documents.
- Mentor and coach colleagues as required.
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project-specific information.
- May take a lead role in developing long-standing relationships with preferred IQVIA customers.
- Deliver presentations/training to clients, colleagues and professional bodies, as required.
- May be involved in activities related to monthly study budget planning and reviews.
About You
To be successful in this role, you will require a Bachelor's Degree in Life Sciences or a related field, and a minimum of 3-5 years' experience in a clinical research environment, preferably with regulatory and study start-up capacity. Strong negotiation and communication skills, excellent interpersonal skills and a proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects are also essential. You will also possess a thorough understanding of regulated clinical trial environments and in-depth knowledge of drug development processes. Proficiency in using systems and technology to achieve work objectives, good regulatory and/or technical writing skills and strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines are also required. Additionally, you should have good leadership skills, with the ability to motivate, coach and mentor, as well as excellent organizational and planning skills and the ability to exercise independent judgment taking calculated risks when making decisions.
About IQVIA
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.