Regional Trial Manager

2 weeks ago

Johannesburg, South Africa Johnson & Johnson Full time

**Regional Trial Manager**

**Location: Gauteng, South Africa/ Nairobi, Kenya**

**Contract: Permanent**

**Job purpose**
- The position is responsible for the regional coordination of clinical trial management activities for outsourced and/or collaborative trials from start-up through study closure in alignment with the Janssen Standard Operating Procedures and applicable Health Authority Regulations.
- Responsibilities primarily focus on investigational site capacity building, Good Clinical Practice (GCP) implementation and quality oversight in collaboration with CRO in region, facilitate regulatory approvals in collaboration with global Regulatory Affairs; oversight of Investigational Medicinal Product (IMP) import and storage in the region; Good Participatory Practice (GPP) implementation and oversight.
- Responsibilities may also include oversight of regional vendors or suppliers.
- The position requires strong operational expertise and knowledge of local clinical research regulations and health care systems.
- This position is a member of the Janssen team - partners with CRO/Partner Team and interfaces with other Global Development (GD) functions, Study Responsible Physician and Global Clinical Operations (GCO) or CRO/vendor staff and Study Sites (if applicable).
- Reports for the project to the GD Trial Leader (GTL) and is member of the Cross-functional Trial Team, led by the GTL.

**The responsibilities & the impact YOU will have**:
**The main duties and responsibilities of the position are**:

- Assesses the need to build capacity and contributes to capacity building where needed, including follow up on basic infrastructure building for site, local lab and/or local pharmacy/depot.
- Demonstrates deep knowledge of global (ICH) and different local regulations and guidelines in the region, as well as Janssen Policies, SOP’s and study protocols.
- Invests in relationship building with local stakeholders to strengthen and optimize the regulatory framework for clinical research including Genetically Modified Organism based IMP and Material Transfer Agreements for biological samples.
- Helps Ensure appropriate safety reporting procedures are in place per Janssen Policies, and applicable local regulations, and acts as liaison to Global Medical Safety (GMS) and Local Safety Officer (LSO)
- Supports Review and approval of the Local IMP label; manage local depot quality and issue handling; identify import license requirements and support IMP import.
- Contribute to local GPP implementation based on central GPP guidelines, and practical GCP experience/adherence. May contribute to local community engagement strategies.
- Provides sponsor oversight and Support of clinical trial execution in the region by means of:

- Trial execution in the region is in compliance with Janssen SOP’s and policies, international and local regulations, and are aligned with local health care system. And protocol compliance
- Participation in preparation for, and conduct of, Health Authority inspections and internal Quality Assurance audits. Support CRO/partner to ensure that trial sites are continuously inspection ready. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
- Reviews (On-Site Compliance) Monitoring Visit Reports submitted by the CRO and ensures action items are followed up in time and with the appropriate quality. Identify trends across countries within the region and initiate corrective actions in collaboration with CRO and Janssen internal functions.
- Performs (or participates if initiated by CRO) lessons learned activities and knowledge sharing across in
- house (leverage with GCO) and the outsourced protocols and with internal and external stakeholders relevant to the region.
- Support the global team in Management of regional vendors and their issue handling and contribute to contingency/mitigation plans where needed.
- Act as the Sponsor contact person for the local teams of the partners and/or CRO. Establish and maintain excellent working relationships with internal and external stakeholders. Demonstrates deep knowledge of protocol and procedures, adequate therapeutic area knowledge, and practical implementation in the region.
- May collaborate with CRO/Partner for:

- Country protocol feasibility and site feasibility assessment
- Provide regional intelligence/guidance to study teams in regard to actual or forecasted CRO Out of Pocket Expenses or other vendor related expenses linked to the region and review assigned vendor invoices/spend on ad hoc basis and as applicable.
- Contribute to study-specific documents to account for region specific requirements or needs, such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archi

  • Regional Manager

    4 weeks ago

    Johannesburg, South Africa Shoprite Group Full time

    Closing Date 2024/02/27 - Reference Number SHO240219-7 - Job Title Regional Manager - Job Type Permanent - Location - Country South Africa - Location - Province Gauteng - Location - Town or City Johannesburg - Purpose of the Job House & Home, a division of The Shoprite Group, Africa's largest retailer, currently has an exciting opportunity available to join...

  • Regional Manager

    4 weeks ago

    Johannesburg, South Africa Shoprite Group Full time

    **Purpose of the Job**: House & Home, a division of The Shoprite Group, Africa's largest retailer, currently has an exciting opportunity available to join our team as a Regional Manager based in Johannesburg. To manage a group of stores through managers by providing support and guidance to ensure all goals and objectives set for the region are met. **Job...

  • Regional Manager

    5 days ago

    Johannesburg, South Africa Rain Full time

    **Job Purpose**: The Regional Manager will be responsible for managing a team of employees, ensuring the successful execution of business strategies, and building a positive and inclusive culture within the regional office. **Key Responsibilities**: - Manage day-to-day operations of the regional office, including overseeing all employees - Develop and...

  • Regional Manager

    6 days ago

    Johannesburg, South Africa FOUR POINT 0 Full time

    Renewable Energy company is looking for Regional Manager to join their vibrant team.The Regional Manager will oversee all business aspects within the designated region, primarily focusing on sales while encompassing operations, technical service, and customer support. Reporting directly to the Chief Commercial Officer, the Regional Manager will be critical...

  • Regional Manager

    2 weeks ago

    Johannesburg, South Africa Adzuna ZA B C2 Full time

    The Regional Manager will oversee all business aspects within the designated region, primarily focusing on sales while encompassing operations, technical service, and customer support. Reporting directly to the Chief Commercial Officer, the regional Manager will be critical in driving revenue growth, enhancing operational efficiency, and delivering...

  • Regional Manager

    5 days ago

    Johannesburg, South Africa Adzuna ZA B C2 Full time

    The Regional Manager will oversee all business aspects within the designated region, primarily focusing on sales while encompassing operations, technical service, and customer support. Reporting directly to the Chief Commercial Officer, the Regional Manager will be critical in driving revenue growth, enhancing operational efficiency, and delivering...

  • Regional Manager

    2 weeks ago

    Johannesburg, South Africa FOUR POINT 0 Full time

    The Regional Manager will oversee all business aspects within the designated region, primarily focusing on sales while encompassing operations, technical service, and customer support. Reporting directly to the Chief Commercial Officer, the regional Manager will be critical in driving revenue growth, enhancing operational efficiency, and delivering...

  • Regional Manager

    6 days ago

    Johannesburg, South Africa FOUR POINT 0 Full time

    The Regional Manager will oversee all business aspects within the designated region, primarily focusing on sales while encompassing operations, technical service, and customer support. Reporting directly to the Chief Commercial Officer, the Regional Manager will be critical in driving revenue growth, enhancing operational efficiency, and delivering...

  • Regional Manager

    6 days ago

    Johannesburg, South Africa FOUR POINT 0 Full time

    The Regional Manager will oversee all business aspects within the designated region, primarily focusing on sales while encompassing operations, technical service, and customer support. Reporting directly to the Chief Commercial Officer, the Regional Manager will be critical in driving revenue growth, enhancing operational efficiency, and delivering...

  • Regional Product Manager

    4 weeks ago

    Johannesburg, South Africa TalentCru Full time

    Are you ready to take on a dynamic role as a key player in the automotive industry? Join our team as a Regional Product Manager based in South Africa, reporting directly to the Regional Category Manager.As the Regional Product Manager, you will be at the forefront of portfolio management, development, and interface with the regional sales team. Your role as...

  • Regional Product Manager

    3 weeks ago

    Johannesburg, South Africa TalentCru Full time

    Are you ready to take on a dynamic role as a key player in the automotive industry? Join our team as a Regional Product Manager based in South Africa, reporting directly to the Regional Category Manager. As the Regional Product Manager, you will be at the forefront of portfolio management, development, and interface with the regional sales team. Your role as...

  • Regional Sales Manager

    4 weeks ago

    Johannesburg, South Africa Mass Staffing Projects Full time

    **Job Information** - Location- Johannesburg- Salary- R780k - R600k- Job Type- Permanent- Education- Matric & Degree/Diploma in Business or Life Sciences- Experience- 3+ years’ experience as a Regional Sales Manager- Reference- REGSM56- - pharmacy.jobs(at)staffingprojects.co.za- Fax- 0866023398We are looking for a Regional Sales Manager for a...

  • Regional Sales Manager

    4 weeks ago

    Johannesburg, South Africa VALMET SOUTH AFRICA (PTY) LTD Full time

    Valmet's Flow Control business line is a global leader in flow control solutions and services. Our valves and valve automation technologies are known for quality, reliability and highest safety. Our customers operate in oil and gas refining, pulp, paper and bioproducts industry, chemicals and other process industries. With our market-leading expertise,...

  • Regional Sales Manager

    4 weeks ago

    Johannesburg, South Africa Pollock and Associates Full time

    Regional Sales Manager FMCG / Food & Bev /Agri Johannesburg North, Johannesburg - Gauteng - South Africa As a Regional Sales Manager, your primary responsibility is to achieve product distribution, display, and volume objectives for strategic products within your assigned geographical region. You will lead and manage the Sales team, ensuring alignment with...

  • Clinic Development Centre

    4 weeks ago

    Johannesburg, South Africa Novo Nordisk Full time

    Are you ready to make the next step in your professional development in a global expanding company? Join Novo Nordisk as Clinic Development Centre (CDC) Project Manager and get a life-changing career! This role is based in Johannesburg, South Africa and directly reports to CDC Clinical Research Manager. **The position** As CDC Project Manager, you will be...

  • Regional Sales Manager

    4 weeks ago

    Johannesburg, South Africa Job Crystal Full time

    A payment solutions provider is looking for a Regional Sales Manager in Durban to manage and be responsible for his/her territory against the new business acquisition targets across 3 Group Products, as well as overall retention of the client base. The Regional Manager’s responsibilities include sourcing and retaining solid talent, managing, and leading...

  • Regional Sales Manager

    4 weeks ago

    Johannesburg, South Africa JV Human Capital Full time

    **Responsibilities**: - Create regional sales plans and targets in alignment with business objectives. - Support Dealer Network with operation - Evaluate Dealership and individual performances. - Report on regional sales results - Forecast quarterly and annual targets, budgets. - Develop new Dealership staff. - Prepare and review the annual budget for the...

  • Regional Manager

    2 weeks ago

    Johannesburg, South Africa Call Centre Staffing Full time

    Sales Manager wanted to manage a large region with various retail outlets. **Responsibilities** Performance management IR issues Sales reports Manage a team of Supervisors and escalations from the stores. **Requirements**: at least 5 years sales management experience in a face to face environment Own vehicle Business management, marketing or sales...

  • Regional Manager

    7 days ago

    Johannesburg North, South Africa Esteem Recruitment Full time

    **Key Responsibilities** - Manage Regional and store performance - Turnover - Profit - Net contribution - New accounts - Stock losses - Turnover per head -TPH (Productivity) - Cost - Controllable expenses - New accounts - Customer satisfaction (experience measurement) - Business and operational plans, objective setting, priority setting, scheduling, etc. -...

  • Regional Manager

    7 days ago

    Johannesburg, South Africa Matched Recruitment Full time

    My client, a National Bargaining Council is currently looking for an experienced, educated and strong Regional Manager for Gauteng. The purpose of the role is to manage regional operations and ensure the best use of resources to enforce the Industry Collective Agreement through sound internal processes, administration, dispute resolutions and compliance...