Regulatory and Start Up Manager

3 weeks ago

Dublin, Dublin City, Ireland IQVIA Full time

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. Global experience and exposure required.

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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q2 Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled


  • Vendor Start-up Manager

    4 weeks ago

    Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Vendor Start-up Manager (VSM) is responsible for providing expertise in support of outsourced clinical trial activities during study startup. The VSM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization. This role proactively assesses...

  • FS Regulatory

    2 months ago

    Dublin, Dublin City, Ireland Idex Full time

    A Leading Global Law Firm based in Dublin is seeking a Financial Service Regulatory Lawyer with 3-6 years' experience dealing with financial services regulatory matters.This hire is to specifically support the financial services regulatory product offering. The practice may be subdivided into three parts: (i) freestanding contentious and non-contentious...

  • Regulatory/Clinical Director

    3 weeks ago

    Dublin, Dublin City, Ireland Wallace Myers International Full time

    Position Title: Regulatory Affairs / Clinical Director (Manager level will be considered) Position Summary The Regulatory/Clinical Director provides independent regulatory/clinical guidance to product development teams on international pre-marketing applications, and any related submissions to support optimal timelines for new/modified product launches. This...

  • Regulatory Response Associate

    1 month ago

    Dublin, Dublin City, Ireland PE Global (UK) Full time

    The Role PE Global are recruiting for a Regulatory Response Associate for our US Multinational accommodation services client based in Dublin CC. 11 -month contract- remote role initially then will move to hybrid. Job Responsibilities Manage complex, sensitive, and/or urgent cases that might pose a significant risk to the brand or ability to operate in...

  • Regulatory Escalations Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Facebook Full time

    Meta is seeking an Escalations Specialist to join the Detection, Response, and Intelligence, Regulatory Escalations Team. The team develops bespoke and semi - scaled solutions to escalatory issues, and novel and emerging regulatory, legal and civic risks facing the company. The team also protects users by mitigating negative engagement on the site and...

  • Regulatory Affairs and Compliance Analyst

    4 weeks ago

    Dublin, Dublin City, Ireland SERVPRO of Upper Cape Cod & the Islands Full time

    Regulatory Affairs and Compliance Analyst page is loaded Regulatory Affairs and Compliance Analyst Apply remote type Hybrid locations Ahmedabad, India Milacron time type Full time posted on Posted 30+ Days Ago job requisition id R-2222 Work You'll Do: Reviewing and marking up agreements with a focus on commercial contracts and non-disclosure agreements ...

  • HEO - Platform Supervision and Regulatory Operations​ (FTC)

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    About Coimisiún na MeánCoimisiún na Meán has been established further to the provisions of the Online Safety and Media Regulation Act 2022 ("OSMR Act 2022"). The OSMR Act 2022 was enacted on 10 December 2022. The OSMR Act 2022 amended the Broadcasting Act 2009 to establish Coimisiún na Meán and dissolve the Broadcasting Authority of Ireland ("BAI"). In...

  • Chemist/Scientist - Analytical Technical Steward mAbs

    4 weeks ago

    Dublin, Dublin City, Ireland eli lilly and company Full time

    Chemist/Scientist - Analytical Technical Steward mAbs Apply locations IE: Kinsale, time type Full time, posted on Posted 30+ Days Ago, job requisition id R-55055 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world...

  • Compliance Manager

    1 month ago

    Dublin, Dublin City, Ireland Cpl Full time

    This Asset Management firm manages 3 UCITS Umbrella Funds - in Luxembourg (1 fund) and in Ireland (2 funds). The firm is in the process of extending its authorisation to become a Super ManCo (with an AIFM and MiFID top up licence). The firm is looking to recruit an enthusiastic professional, reporting to the Company Chief Compliance Officer (CCO)/ DP for...

  • Operations Specialist Manager

    3 weeks ago

    Dublin, Dublin City, Ireland IQVIA Argentina Full time

    As an Operations Specialist Manager (m/w/d) , you will apply knowledge and expertise including complex decision-making activities to review, assess and process Safety data and information across service lines. You will provide oversight on small to medium service operational projects and act as mentor to junior members of staff. You may also act as...

  • Finance Director, Dublin

    4 weeks ago

    Dublin, Dublin City, Ireland BeInCrypto Full time

    What You'll Be Doing: Take ownership and manage accounting, tax, internal controls, cost management, accounts payable, management reporting, and regulatory reporting areas for OK Group's payments entity Prepare financial statements for external audits, regulatory reporting/inquiries, and management reporting Implement a month closing process for the local...

  • QC Raw Materials

    3 weeks ago

    Dublin, Dublin City, Ireland WuXi Biologics Ireland Limited Full time

    Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The...

  • Manager - Client Reporting

    3 weeks ago

    Dublin, Dublin City, Ireland EPIC Investment Partners Full time

    About Us EPIC Investment Partners ("EPIC") is a global financial services platform with 230 people across four integrated divisions Capital, Markets, Administration and Advisory.EPIC was founded in 2001 by Giles Brand and Hiren Patel, financial services entrepreneurs with backgrounds in private equity. Business building is at the heart of everything we do....

  • Risk and Compliance Manager

    2 months ago

    Dublin, Dublin City, Ireland Broadgate Full time

    Risk & Compliance Manager (FTC)Wealth ManagementDublin - Hybrid70-75K Broadgate has partnered with a prominent financial services firm renowned for its expertise in investment advice and pension management. My client is looking to hire a Risk and Compliance Manager for a 12-month FTC, with the possibility for an extension (18 months). What is in for you?Base...

  • Compliance & Risk Manager

    1 month ago

    Dublin, Dublin City, Ireland Broadgate Full time

    Risk and Compliance ManagerFundsDublin - Hybrid75-90K Broadgate has partnered up with a growing Financial Services firm on the appointment of a Risk and Compliance Manager. The role is quite broad and would suit a professional with previous Compliance/Risk managerial experience within the Funds sector. What is in it for you?Salary DOE up to 90K +...

  • Senior Manager Commercial Quality

    2 months ago

    Dublin, Dublin City, Ireland J&J Family of Companies Full time

    Senior Manager Commercial Quality - Vision WDescriptionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and...

  • Capital Management Actuary

    2 months ago

    Dublin, Dublin City, Ireland Aviva Full time

    You must have valid Irish, UK, or EU work rights to be considered for this roleLocation: Cherrywood, Dublin 18 with hybrid workingRole Purpose: The Capital Management Actuary is a key member of the Financial Performance team at Aviva Life and Pensions Ireland. The successful candidate will report directly to the Head of Performance and will work closely with...

  • Logistics Manager

    4 weeks ago

    Dublin, Dublin City, Ireland Chartered Institute of Procurement and Supply (CIPS) Full time

    Job Description Vertiv/E+I Engineering is the largest electrical switchgear manufacturer in the UK & Ireland, pioneering unique in-house integrated power solutions tailored to each individual client project. With over 30 years of experience in delivering high-quality integrated power solutions, we are experts in providing technical services, project...

  • Process Engineer

    4 weeks ago

    Dublin, Dublin City, Ireland Allergan Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...

  • QA Operations Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    County Meath, Ireland | Posted on 06/10/2024 Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City County Meath State/Province Meath Country Ireland Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in...