Regulatory and Start Up Manager
1 maand geleden
As a Regulatory and Start Up Manager at IQVIA, you will be responsible for directing and managing the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes pre-award activities, oversight of the scope of work, budget, and resources. Fluency in Dutch and English is required.
Key Responsibilities- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project-related issues where required.
- Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed 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 specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, while enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
- 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.
- Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
- 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.
A Bachelor's Degree in Life Sciences or a related field is required, along with 7 years of relevant experience in a scientific or clinical environment, including demonstrable experience in an international role. Equivalent combination of education, training, and experience is also acceptable.
Strong negotiation and communication skills, with the ability to challenge, are essential. Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects is also required. Thorough understanding of the regulated clinical trial environment and in-depth knowledge of the drug development process are necessary. Good regulatory and/or technical writing skills, strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines, are also required. Good leadership skills, with the ability to motivate, coach, and mentor, are essential. Good organizational and planning skills, ability to exercise independent judgment, taking calculated risks when making decisions, and proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors are also necessary. Excellent understanding of study financial management and proven ability to work on multiple projects, balancing competing priorities, are also required.
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Regulatory and Start Up Manager
3 weken geleden
Amsterdam, Noord-Holland, Nederland IQVIA VoltijdJob OverviewAs a Regulatory and Start Up Manager at IQVIA, you will play a critical role in the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. Your expertise will be essential in overseeing the execution of site activation and maintenance, developing and implementing management plans, and...
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Amsterdam, Noord-Holland, Nederland IQVIA VoltijdJob OverviewAs a Regulatory and Start Up Manager at IQVIA, you will be responsible for directing and managing the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes pre-award activities, oversight of the scope of work, budget, and resources. Fluency in Dutch and...
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