Line Manager Regulatory and Start Up at IQVIA. - Turkey

São Paulo, São Paulo, Brazil -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Requirements, Clinical Trials, Leadership, Budget Management, Negotiation Skills, Communication Skills, Organizational Skills, Interpersonal Skills, Project Management, Problem Solving, Team Collaboration, Technical Support, Quality Management, Documentation, Medical Terminology, Microsoft Office

Industry

Hospitals and Health Care

Description

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. Learn more at https://jobs.iqvia.com IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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Responsibilities

The Line Manager will oversee site activation and maintenance for clinical studies, ensuring compliance with regulatory requirements and project timelines. They will also provide guidance on regulatory strategy and mentor team members.