Regulatory and Start Up Manager

6 months ago

Centurion, South Africa 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.
 

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 or related field Req
7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
Strong negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
Demonstrated proficiency in using systems and technology to achieve work objectives
Good regulatory and/or technical writing skills
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Good leadership skills, with ability to motivate, coach and mentor
Good organizational and planning skills
Ability to exercise independent judgment taking calculated risks when making decisions
Good presentation skills
Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Excellent understanding of study financial management
Proven ability to work on multiple projects balancing competing priorities

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

  • Regulatory and Start Up Manager

    6 months ago

    Centurion, South Africa Novasyte 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. Essential Functions - Oversee the execution of Site Activation (including pre-award/bid defense activities)...

  • Site Activation Manager

    6 months ago

    Centurion, South Africa Novasyte Full time

    Site Activation Manager Global Site Activation - GSA The GSA unit within IQVIA has the vision to be the clear market leader in clinical trial site activation, driving best in class employee, site and customer experiences and we are looking for passionate people to join our team. The Site Activation Manager (SAM) position within GSA team in IQVIA is our...

  • Regulatory and Start Up Specialist 1

    3 months ago

    Centurion, South Africa IQVIA Full time

    **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Essential Functions** - Under general supervision,...

  • Regulatory and Start Up Specialist

    4 weeks ago

    Centurion, South Africa IQVIA Full time

    **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.\ **Essential Functions** - Under general supervision,...

  • Regulatory and Start Up Specialist 2

    2 months ago

    Centurion, South Africa IQVIA Full time

    **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Essential Functions** - Under general supervision,...

  • Regulatory Portfolio Manager

    6 months ago

    Centurion, South Africa Virbac Full time

    Experiencing together a unique human adventure - Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a...

  • Financial Management Professional: Centurion Opportunity

    2 weeks ago

    Centurion, Gauteng, South Africa Private Security Regulatory Authority Full time

    About the RolePrivate Security Regulatory Authority is seeking a skilled Financial Management Professional to join their team in Centurion. This exciting opportunity offers a chance to contribute to the organization's financial success and grow your career.

  • Regulatory Specialist with Regulatory Acumen

    2 weeks ago

    Centurion, Gauteng, South Africa The Independent Communications Authority of South Africa Full time

    Job TitleRegulatory & Legislative Drafting SpecialistCompany OverviewThe Independent Communications Authority of South Africa is a leading regulatory body in the telecommunications industry.Estimated Salary: R 1,200,000 - R 1,800,000 per annumKey ResponsibilitiesProvide legal guidance to the Council on executing their functions in terms of the ICASA...

  • Senior Registration Specialist: Centurion Opportunity

    2 weeks ago

    Centurion, Gauteng, South Africa Private Security Regulatory Authority Full time

    About the RoleWe are seeking a highly skilled and motivated Senior Registration Specialist to join our team in Centurion.Key Responsibilities:Registration of clients and stakeholders with the Private Security Regulatory AuthorityProviding exceptional customer service and supportMaintaining accurate and up-to-date recordsCollaborating with colleagues to...

  • Programme Manager: Document Management and Information Systems

    2 weeks ago

    Centurion, Gauteng, South Africa Private Security Regulatory Authority Full time

    Job Title : Programme Manager: Document Management and Information SystemsWe are seeking a skilled Programme Manager to oversee the management of document information systems for our organization. This role requires strong leadership and analytical skills, with the ability to coordinate multiple projects simultaneously.Key ResponsibilitiesManage document...

  • Logistics Operations Manager

    2 weeks ago

    Centurion, Gauteng, South Africa Private Security Regulatory Authority Full time

    We are seeking a Logistics Operations Manager to join our team at the Private Security Regulatory Authority in Centurion, Gauteng.Key Responsibilities:Manage logistics operations to ensure timely delivery of goods and servicesCo-ordinate with suppliers and stakeholders to meet business needsRequirements:National Diploma/Degree in Supply Management, Logistics...

  • Regulatory Law Specialist

    2 weeks ago

    Centurion, Gauteng, South Africa The Independent Communications Authority of South Africa Full time

    About the RoleWe are seeking a highly skilled Regulatory Law Specialist to join our team at The Independent Communications Authority of South Africa.Job Description:The successful candidate will report to the Senior Manager: Regulatory & Legislative Drafting and will be responsible for providing legal guidance to the Council, CEO, COO, EXCO/OPCO and...

  • Regulatory Compliance Specialist

    6 months ago

    Centurion, South Africa Momentum Investments Full time

    **Introduction** Through our client-facing brands Metropolitan and Momentum, with Multiply (wellness and rewards programme), and our other specialist brands, including Guardrisk and Eris Property Group, the group enables business and people from all walks of life to achieve their financial goals and life aspirations. **Role Purpose** The purpose of this...

  • Regulatory Affairs Manager

    2 weeks ago

    Centurion, South Africa Virbac Full time

    Experiencing together a unique human adventure - Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a...

  • Chief Security Risk Manager

    3 weeks ago

    Centurion, Gauteng, South Africa Level-Up Full time

    Level-Up is seeking an experienced Chief Security Risk Manager to join our team on a full-time, permanent basis. The ideal candidate will have a strong background in both security and investigations, with a proven track record of identifying and mitigating potential risks and threats.Key Responsibilities:Conduct thorough investigations into any security...

  • Regulatory Compliance Manager

    4 weeks ago

    Centurion, Gauteng, South Africa Gijima Holdings Full time

    Job OverviewGijima Holdings is seeking a highly skilled Regulatory Compliance Manager to lead our strategic guidance initiatives. In this role, you will be responsible for ensuring compliance with regulatory requirements and providing expert advice to internal stakeholders.

  • Regulatory & Legislative Drafting Specialist

    2 weeks ago

    Centurion, South Africa The Independent Communications Authority of South Africa Full time

    Job title : Regulatory & Legislative Drafting Specialist Job Location : Gauteng, Centurion Deadline : December 27, 2024 Quick Recommended Links Jobs by Location Job by industries Key Outputs:  The successful candidate will report to the Senior Manager: Regulatory  & Legislative Drafting and their responsibilities will include:  ...

  • Regulatory & Legislative Drafting Specialist

    2 weeks ago

    Centurion, South Africa The Independent Communications Authority of South Africa Full time

    Job title : Regulatory & Legislative Drafting SpecialistJob Location : Gauteng, CenturionDeadline : December 27, 2024Quick Recommended Links Jobs by Location Job by industries Key Outputs:  The successful candidate will report to the Senior Manager: Regulatory  & Legislative Drafting and their responsibilities will include:  Provide legal guidance to...

  • Regulatory Compliance Specialist: Cisca

    6 months ago

    Centurion, South Africa Momentum Investments Full time

    **Introduction** Through our client-facing brands Metropolitan and Momentum, with Multiply (wellness and rewards programme), and our other specialist brands, including Guardrisk and Eris Property Group, the group enables business and people from all walks of life to achieve their financial goals and life aspirations. **Role Purpose** The purpose of this...

  • Associate Director, Regulatory Affairs

    6 months ago

    Centurion, South Africa FHI Clinical Inc Full time

    **Essential Functions**: - Expected to be the accountable point of contact for designated clients, responsible not only for RA deliverables but also for proactive communication and budget adherence. - Act as the Lead Regulatory Professional for regulatory projects awarded to FHIC, with support from other senior colleagues. - Provides Clinical Research...