Local Study Associate Director FSP
Share
Job Location:
Centurion - South Africa
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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
Bachelors 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 companys Corporate Standards
- Strong knowledge of budget management and resourcing
- Considerable working knowledge of medical terminology
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
