Regulatory and Start Up Manager
1 week ago
**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.
**_Home Based role, which will require yearly travel for Bid-defense meetings and study kick-off meetings. Experienced required with Site Activation within SSA / MENA
- **
**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**
**7 years’ relevant experience**in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
- Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
- 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
- Excellent understanding of study financial management
-
Regulatory and Start Up Manager
2 days ago
Centurion, South Africa Novasyte Full timeJob 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
1 week ago
Centurion, South Africa Novasyte Full timeSite 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...
-
Site Activation Manager
2 days ago
Centurion, South Africa Novasyte Full timeSite Activation Manager (Project Manager of Start-up of a Clinical Trial) Job Family Description Sub-Family Description Project manager for the start-up phase in charge of design and implementation of the strategy towards site activation from award until open to enrollment. Lead and oversee the country operations teams ensuring client commitments are...
-
Clinical Operation Manager
1 week ago
Centurion, South Africa IQVIA Full timeYou will 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. The role may also include maintenance activities. This is not a line management position but requires...
-
Clinical Operation Manager
2 days ago
Centurion, South Africa Novasyte Full timeYou will 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. The role may also include maintenance activities. This is not a line management position but requires...
-
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...
-
Start-up Specialist
1 week ago
Centurion, South Africa Labcorp Full timeHere at Labcorp Drug Development we are currently recruiting for a Study Start Up Specialist. Main responsibilities: - Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance - Ensure that all assigned maintenance and Start-up activities are on track...
-
Regulatory Affairs Manager
2 weeks ago
Centurion, South Africa Mayfly Agri (Pty) Ltd Full time**Minimum requirements for the role**: - Must have a relevant tertiary qualification - 5-8 years experience within the agricultural regulatory environment is essential - Solid understanding of Act 36 requirements will be required - Must have excellent communication skills - Must be able to build relevant relationships within the industry and at the...
-
Manager: Regulatory Compliance
7 days ago
Centurion, South Africa Construction Industry Development Board Full timeOversee and approve activities with regards to the legislative process. **Oversee Compliance **- Oversee the implementation and maintenance of the compliance management system - Oversee that cidb’s service delivery framework is in line with legislation - Oversee reports for submission to senior management, Council, Auditor General, etc. outlining...
-
Centurion, South Africa Independent Communications Authority of SA Full timeRegulatory and Legislative Drafting Specialist x3 Centurion, South Africa VACANCY JOB TITLE : Regulatory and Legislative Drafting Specialist X 3 JOB LEVEL : D1 SALARY RANGE : TotalAnnual Package (CTC) - R814,602.00 - R958,356.00 POSITION STATUS : 4 (Four) Years Fixed Term Contract Purpose of the job To ensure that ICASA adheres to administrative due process...
