Manager, Regulatory & Study Start Up

IQVIA Digital, Inc. (USB1); Ciudad de México; Presencial; MXN 1,126,000 - 1,503,000; Jornada completa

Descripción de la vacante

A leading clinical research firm in Mexico is seeking a professional to manage site activation and regulatory activities for clinical studies. The ideal candidate will have extensive experience in clinical research, particularly in a leadership role, and demonstrate strong communication and budget management skills. Join us to contribute to improving patient outcomes and healthcare intelligence.

Formación

• 6 years of clinical research experience, including 3 years in a leadership role.
• Full knowledge of drug development processes and regulatory requirements.
• Ability to independently manage new processes and motivate teams.

Responsabilidades

• Oversee site activation and maintenance activities for clinical studies.
• Collaborate across teams to deliver project scope and compliance.
• Provide guidance and oversight during initial startup and maintenance phases.

Conocimientos

Clinical research experience

Leadership

Budget management

Regulatory knowledge

Effective communication

Educación

Bachelor's Degree in a related field

Herramientas

Microsoft Office

Descripción del empleo

Job Overview
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.

Essential Functions
• 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, whilst 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.

Qualifications
• Bachelor's Degree Related field Req
• 6 years clinical research experience, including 3 years experience in a leadership capacity. Equivalent combination of education, training and experience.
• Full knowledge of drug development process
• Full knowledge of applicable regulatory requirements, SOPs, and company’s Corporate Standards
• Strong knowledge of budget management and resourcing
• Considerable working knowledge of medical terminology
• Strong knowledge of Microsoft Office and e-mail applications
• Effective communication, organizational, interpersonal, and leadership skills
• Strong negotiation skills
• Ability to independently coordinate and manage new processes
• Ability to lead and motivate teams
• Ability to handle management/personnel issues
• Ability to work independently and to effectively prioritize tasks
• Ability to work well within a matrix team environment
• 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. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com