Line Manager Regulatory And Start Up

Iqvia Llc; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A global healthcare services organization is seeking a Line Manager for Regulatory and Start Up in São Paulo, Brazil. The successful candidate will direct site activation strategies and oversee regulatory activities for clinical studies. Applicants must have a Bachelor's Degree in Life Sciences, 4-5 years of relevant experience, and strong leadership skills. The role demands fluency in English and a deep understanding of drug development processes alongside regulatory compliance, with potential for mentoring other team members.

Qualificações

• 4-5 years of regulatory and start-up clinical research experience.
• 1 year in a leadership capacity.
• Fluent in English (spoken, read, written).

Responsabilidades

• Direct and manage site activation and regulatory activities.
• Ensure collaboration across teams for project delivery.
• Mentor and coach colleagues as required.

Conhecimentos

Regulatory knowledge

Leadership

Negotiation skills

Budget management

Microsoft Office proficiency

Effective communication

Formação académica

Bachelor's Degree in Life Sciences or related field

Descrição da oferta de emprego

Line Manager Regulatory and Start Up page is loaded Line Manager Regulatory and Start Up – Locations: São Paulo, Brazil Time type: Full time Posted on: Posted Yesterday Job requisition id: R

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 Life Sciences, Health or related.

• 4 - 5 years of regulatory and start up clinical research experience.
• 1 year experience in a leadership capacity / management people.
• Fluent English: Spoken, Read, Written.
• Location: Sao Paulo.
• Ability to lead and motivate teams.
• Strong negotiation skills.
• 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.
• Ability to independently coordinate and manage new processes.
• 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.

Thank you for your interest in growing your career with us.