Associate Country Clinical Quality Manager South

2 weeks ago

Midrand, Gauteng, 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 / procedures, the identification of opportunities for process improvement, and continuous improvement initiatives.

In addition, the Associate CCQM supports audits, inspections as well as Quality Control and local training activities.

Secondary Language(s) Job Description**:

Qualifications:

  • Bachelor's Degree or equivalent in relevant health care area.

Experience:

  • A minimum of 46 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
  • Knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
  • Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
  • Experience of participating in crossfunctional teams of business professionals, Experience of leading a crossfunctional team is a plus.
  • Experience of participating in audits and inspections, preferably with experience of a direct support.
  • Experience of coordinating and delivering training sessions is a plus.

Skills:

  • Superior oral and written communication skills in an international environment.
  • Good project management, organizational and prioritization skills.
  • Good teamwork and leadership skills, including the ability to resolve conflicts.
  • Ability to analyze, interpret, and solve problems.
  • Ability to think objectively and with creativity and innovation

Regulations & Processes:

  • Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
  • In close collaboration with local country operations management, supports the CCQM in managing the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
  • Local expert for any qualityrelated local processes.
  • Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).
  • Supports continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports continuous improvements activities at the local/regional level.

Training:

  • Supports local trainings (as needed).

Quality Control (QC) Activities:

  • In conjunction with the local country operations management, supports the CCQM in the coordination, and oversight of all QC activities. This includes to ensure a proper execution of the Inhouse Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
  • In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
  • On a regular basis and in collaboration with local country operations, supports the CCQM during identification of local trends, rootcauseanalysis (if necessary), and the development of local action plans (incl. sharing of results and training of local country operations, if required).

Audits & Inspections:

  • Supports activities during the preparation / ongoing / followup phase of an audit or inspection.
  • In cooperation with local country operations and/or headquarters, supports rootcause analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
  • On a regular basis and in collaboration with local country operations, supports the CCQM during identification of local trends, rootcauseanalysis (if necessary) and the development of local action plans (incl. sharing of results and training of local country operations, if required).

Quality / Compliance Issue Escalation:

  • Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
  • If indicated, escalates significant quality/compliance issues per company process and supports investigations (fact finding, rootcauseanalysis) as well as the reporting of 'Serious Breaches', if applicable.
  • Local POC for escalations of Privacy Breaches that occurred in clinical trials, or supports local POC for escalations of Privacy Breaches, if necessary.

Clinical Supplies GCP Investigations

  • Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
  • Coordinates GCP Investi

  • Associate Country Clinical Quality Manager South

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    It is critical that, for all Organisation-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Associate CCQM position has an important impact in achieving those objectives. Under the guidance of the Regional Director, Clinical Quality Management (RCQM) and in...

  • Country Clinical Quality Manager

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    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.It is critical that, for all company-sponsored clinical trials, patient...

  • Associate Clinical Research Manager

    2 weeks ago

    Midrand, Gauteng, 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...

  • Associate Clinical Operations Manager Ii

    2 weeks ago

    Midrand, Gauteng, 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 of the Sr....

  • Associate Clinical Operations Manager 1

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    Brief Description of Position:This role is accountable for performance and compliance for assigned protocols in a country 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 of the Sr. COM, Head COMs or CRD, the...

  • Associate Clinical Research Associate

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    With support of Senior Clinical Research Associate/Clinical Research Associate and/or CRA Manager, the Associate CRA acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.Primary Responsibilities: Develops strong site relationships and ensures continuity of site...

  • Clinical Operations Manager

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. Clinical Operations Manager, Head COMs or...

  • Associate Clinical Operations Manager II

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    Job DescriptionBrief Description of Position:This role is accountable for performance and compliance 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. Under the oversight of the COM Lead, Head COMs or...

  • Associate Clinical Operations Manager II

    3 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    Job DescriptionBrief Description of Position:This role is accountable for performance and compliance 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. Under the oversight of the COM Lead, Head COMs or...

  • Country Head Medical Affairs

    2 weeks ago

    Midrand, Gauteng, South Africa Novartis Full time

    Summary:The Country Medical Affairs Head is the lead country medical representative, responsible for adopting and executing the near- and long-term medical strategy coming from Global/International, forging bold strategic partnership with the healthcare communities and governmental entities. Manage and develop the overall performance of the medical unit in...

  • Clinical Research Associate

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    The role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Sr. Clinical Research Associate

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or Clinical Research Director, the person ensures compliance of study conduct with ICH/Good Clinical Practice and country regulations, our company's policies and procedures, quality standards and adverse event reporting...

  • Clinical Research Associate

    4 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally...

  • Clinical Research Associate

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally...

  • Clinical Research Associate

    4 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally...

  • Clinical Research Associate

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally....

  • Associate Clinical Research Associate

    2 weeks ago

    Midrand, Gauteng, South Africa MSD Full time

    Brief Description of PositionWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site...

  • Clinical Operations Manager

    6 days ago

    Midrand, Gauteng, South Africa MSD Full time

    Job DescriptionThis 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 of the COM lead, Head...

  • Clinical Applications Specialist

    2 weeks ago

    Midrand, Gauteng, South Africa Alcon Full time

    Position PurposeThe Clinical Applications Specialist position covers South Africa and is responsible for training customers (Surgeons and Staff) on the approved utilization of Alcon products to ensure safe and appropriate use for optimal patient outcomes.He/She will also have to partner with other Alcon functions.Major Accountabilities Provide clear and...

  • Clinical Operations Manager

    2 weeks ago

    Midrand, Gauteng, South Africa Edge Executive Search Full time

    Are you a dynamic leader with a passion for driving excellence in healthcare operations? Look no further our client is seeking a talented individual to fill the crucial role of Clinical Operations Manager. As part of the dedicated team, you'll play a pivotal role in driving and implementing clinical operations functions across the dialysis units, aligning...