Associate Clinical Research Manager

2 weeks ago

Midrand, South Africa MSD Full time

With support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Associate Clinical Research Manager could be responsible for a particular study for a country or a cluster.

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Responsibilities include, but are not limited to:

- Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate Manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required.
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports Clinical Research Associates as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs).
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with eTMF and other key systems in assigned studies.
- Escalates as needed different challenges and issues to Therapeutic Area Head/ Clinical Research Director/Country Clinical Quality Manager.
- Identifies and shares best practices.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- As a customer-facing role, this position will build business relationships and represent our Company with investigators.
- Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with Clinical Research Director, Therapeutic Area Head and Regional Operations.
- Collaborates internally with Headquarter functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across the trials. Consult with Human Health as needed.

**Qualifications, Skills & Experience**

**Skills**:

- Knowledge in Project Management and/or site management.
- Strong organizational skills with demonstrated success in related role or discipline required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA-Head or CRD
- Requires understanding of local regulatory environment.
- Scientific and clinical research knowledge is required.
- Understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Ability to function as a key link between Country Operations and Clinical Trial Teams
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Ability to manage processes (and controls), productivity, quality and project delivery.
- Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking.
- Ability to work efficiently in a remote and virtual environment.
- Aptitude for building leadership skills that enable and drive alignment with the goals, purpose and mission.
- Ability to identify problems, conflicts and opportunities early, analyses and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, and 5) resolution of conflictive situations.
- Understand cultural diversity.
- Stron

  • Clinical Research Manager

    4 weeks ago

    Midrand, South Africa MSD Full time

    This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...

  • Associate Clinical Operations Manager Ii

    6 days ago

    Midrand, South Africa MSD Full time

    **Brief Description of Position**: This role is accountable for performance and compliance for assigned protocols in **SOUTH AFRICA and OTHER AFRICAN COUNTRIES** in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight...

  • Associate Country Clinical Quality Manager South

    4 days ago

    Midrand, South Africa MSD Full time

    Under the guidance of the Regional Director, Clinical Quality Management (RCQM) and in close collaboration with the Country Clinical Quality Manager (CCQM), the Associate CCQM supports the oversight of specific CQM activities in the respective country/cluster. The role requires the ability to properly support the implementation of local/global processes /...

  • Medical Manager, Oncohematology

    4 weeks ago

    Midrand, South Africa AbbVie Full time

    **Company Description** **Job Description** Medical Manager, Oncohematology** **Summary**: Represent the affiliate’s medical/scientific voice of expertise for assigned product(s) and relevant therapeutic areas. Provide medical / scientific expert advice / guidance to key customers for assigned products and relevant therapeutic areas, including scientific...

  • Clinical Pathologist

    4 weeks ago

    Midrand, South Africa IDEXX Full time

    IDEXX reference laboratories is a global network united by a shared commitment to enhancing pet care where the true strength in our name is the people behind it. Our reference laboratories make it possible for our customers to discover more with our unrelenting commitment to innovation, personalized support, guidance, and expertise, while providing the most...

  • Research Methodology Lecturer

    4 weeks ago

    Midrand, South Africa Eduvos Full time

    **Job Advert Summary**: **Eduvos **is looking to hire the services of an** Independent Contractor Research Methodology **Lecturer for our part-time structure, on a part-time basis.*** **Type of appointment**: **Independent Contractor (part-time; flexible workhours agreement)** **Purpose**: - To lecture Commerce-related modules, in the faculty on a...

  • Application Specialist X-Ray

    6 days ago

    Midrand, South Africa Ultra Personnel Full time

    Must be familiar with General Radiography and Fluoroscopy equipment, both analogue as well as latest DR based digital systems, as well as CR products. Mammography and bone density is a requirement.CBCT and CT/MRI experience will be an advantageTraining end-users on the correct operation of the equipment in line with company standardsAttending key...

  • Application Specialist X-Ray

    6 days ago

    Midrand, South Africa Ultra Personnel Full time

    Must be familiar with General Radiography and Fluoroscopy equipment, both analogue as well as latest DR based digital systems, as well as CR products. Mammography and bone density is a requirement.CBCT and CT/MRI experience will be an advantageTraining end-users on the correct operation of the equipment in line with company standardsAttending key...

  • Application Specialist X-Ray

    5 days ago

    Midrand, South Africa Adzuna ZA B C2 Full time

    Must be familiar with General Radiography and Fluoroscopy equipment, both analogue as well as latest DR based digital systems, as well as CR products. Mammography and bone density is a requirement.CBCT and CT/MRI experience will be an advantageTraining end-users on the correct operation of the equipment in line with company standardsAttending key...

  • Wardrobe Associate

    4 weeks ago

    Midrand, South Africa Crew Life at Sea Full time

    **Uniform Distribution**: - Issue clean and properly sized uniforms to hotel staff members based on their respective roles. - Keep accurate records of uniform distribution to ensure that each staff member receives the appropriate attire. **Inventory Management**: - Maintain an organized inventory of uniforms, including tracking the number of items...

  • Pharmacy Manager

    4 weeks ago

    Midrand, South Africa Clicks Group Limited Full time

    **Listing reference**: click_015176**Listing status**: Online- **Position summary** **Industry**:Wholesale & Retail Trade - **Job category**:Pharmaceutic**Location**:Midrand - **Contract**:Permanent**Remuneration**:Market Related - **EE position**:Yes**Introduction** - To ensure the efficient operation of the dispensary and the clinic and to ensure service...

  • Medical Sales and Application Specialist

    4 weeks ago

    Midrand, South Africa Ultra Personnel Full time

    Grade 12 certificate as a minimum requirementRadiography / Sonography qualification and working experience is requiredPrevious sales experience would be an advantageOwn transport is essentialDuties:Developing an in-depth knowledge of the Ultrasound product range and services providedResponsible for the sales of the ultrasound products, including maintaining...

  • Medical Sales and Application Specialist

    3 weeks ago

    Midrand, South Africa Adzuna ZA B C2 Full time

    Grade 12 certificate as a minimum requirementRadiography / Sonography qualification and working experience is requiredPrevious sales experience would be an advantageOwn transport is essentialDuties:Developing an in-depth knowledge of the Ultrasound product range and services providedResponsible for the sales of the ultrasound products, including maintaining...

  • Medical Sales and Application Specialist

    3 weeks ago

    Midrand, South Africa Ultra Personnel Full time

    Grade 12 certificate as a minimum requirementRadiography / Sonography qualification and working experience is requiredPrevious sales experience would be an advantageOwn transport is essentialDuties: Developing an in-depth knowledge of the Ultrasound product range and services provided Responsible for the sales of the ultrasound products, including...

  • Cyber Security Specialist

    3 weeks ago

    Midrand, South Africa Gijima Holdings Full time

    RESPONSIBILITIES:Administration of Vulnerability Management Security Solutions and researching, designing & developing additional protection technologiesInstallation, management & support of the following Products: Tenable.IO and associated products and Qualys and associated productsPresenting vulnerabilities in client meetings at a CIO/CEO levelKeeping...

  • Cyber Security Specialist

    3 weeks ago

    Midrand, South Africa Gijima Holdings Full time

    RESPONSIBILITIES: Administration of Vulnerability Management Security Solutions and researching, designing & developing additional protection technologies Installation, management & support of the following Products: Tenable.IO and associated products and Qualys and associated products Presenting vulnerabilities in client meetings at a CIO/CEO level Keeping...

  • Regulatory Affairs Associate

    6 days ago

    Midrand, South Africa Alcon Full time

    At Alcon, we are driven by the meaningful work we do to help our patients see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...

  • Head of Department: Engineering Faculty

    4 weeks ago

    Midrand, South Africa The Academic Institute of Excellence Full time

    The institute has a job opening for a **Head of Department: Engineering **within our **academic structure**. The position requires a highly motivated individual who will do both teaching and carrying out research. We’re in search of an individual who is capable of providing strong academic leadership with a vision to deliver a quality driven academic...

  • Social Media Manager

    6 days ago

    Midrand, South Africa TiAuto Investments Pty Ltd Full time

    **Objectives of this role**: Work closely with retail manager, design team and digital team to meet company objectives. Developing social strategy and grow staple of brands social media accounts. Stay active and abreast with technologies associated with social media as well as platform updates. **Responsibilities include**: (For multiple brands +-...

  • Product Manager

    4 weeks ago

    Midrand, South Africa LightWare LiDAR Full time

    **MAIN PURPOSE**: Craft and drive the strategy for growing a successful and profitable portfolio of products throughout their lifecycles, by understanding market needs, defining the product vision, and collaborating with engineering, sales, marketing, and technical support to ensure revenue and customer satisfaction goals are met. **AREAS OF...