Associate Regulatory and Start Up Manager

Nanosep AB; London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the healthcare industry is seeking an Associate Regulatory and Start Up Manager in London. The role involves managing regulatory activities and supporting clinical trial processes while ensuring compliance with corporate standards. The ideal candidate should have a degree in a related field and relevant clinical research experience.

Qualifications

• 3 years clinical research experience, including 1 year in a leadership capacity.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Broad knowledge of clinical research.

Responsibilities

• Direct and manage site activation and regulatory activities.
• Oversee project execution in accordance with the RSU strategy.
• Provide regulatory and technical support for clinical trials.

Skills

Regulatory Compliance

Clinical Research

Project Management

Education

Bachelor's Degree in Related Field

Job description

Associate Regulatory and Start Up Manager

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Associate Regulatory and Start Up Manager

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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.

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

3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.

• In-depth knowledge of clinical systems, procedures, and corporate standards
• Broad knowledge of clinical research
  
  

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.

EEO Minorities/Females/Protected Veterans/Disabled

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Operations Consulting

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