Country Clinical Quality Manager at IQVIA

IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services,...

 

Country Clinical Quality Manager

  • Job TypeFull Time
  • QualificationBA/BSc/HND
  • Experience
  • LocationNairobi
  • Job FieldMedical / Healthcare 

Essential Functions

  • Adopt and implement the global Quality Management Plan within the scope of the assignment, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.;
  • Cooperate closely with the relevant  business and other stakeholders, support maintaining focus on quality in project delivery.
  • Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
  • Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
  • Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.);
  • Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
  • Inform  Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
  • Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
  • May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs.
  • Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
  • Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
  • Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.

Qualifications

  • Bachelor's Degree Bachelor's Degree or equivalent qualification  Req
  • Equivalent combination of education, training, and experience.
  • Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
  • Knowledge of National and International Regulations and Drug Development processes.
  • Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
  • Knowledge of IQVIA corporate standards and SOPs.
  • Good organizational, interpersonal and communication skills.
  • Good judgement and decision-making skills.
  • Strong influencing and negotiation skills.
  • Strong computer skills including Microsoft Office applications.
  • Excellent problem solving skills.
  • Ability to travel within the region/country.
  • Ability to lead and motivate a clinical team.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
  • Fluent in English.

Method of Application

Interested and qualified? Go to IQVIA on jobs.iqvia.com to apply

Comments

Post a Comment

Popular posts from this blog

Operations Associate at Kopo Kopo Inc

Kopo Kopo was launched in 2012 where we partnered with Safaricom to bring Lipa na M-Pesa Buy Goods service to small and medium businesses throughout Kenya and, today, we serve thousands of businesses from salons to restaurants to office supply stores, to schools. We have since partnered with other aggregator and mobile money partners with the ultimate goal of helping businesses leverage mobile payments. We are grateful for our unusual journey and look forward to helping our merchants in growing and prosper in the years ahead.   Operations Associate Job Type Full Time Qualification BA/BSc/HND Experience Location Nairobi Job Field Customer Care  Salary Range KSh 50,000 - KSh 100,000/month The Job:   The role will combine aspects of customer service and operations duties. Ultimately, you will be responsible for quickly solving problems for businesses that rely on Kopo Kopo’s technology. You will ensure that Kopo Kopo’s information systems are kept up to date, and will engage...
Read more

Senior Communications Officer at Natural State

Through large-scale restoration and rewilding, NATURAL STATE secures biodiversity, sequesters and stores carbon, and helps achieve the Sustainable Development Goals. Our goal at the NATURAL STATE research centre is to develop technology and financial systems that will catalyse large-scale restoration globally as well as help train future leaders for this...   Senior Communications Officer Job Type Full Time Qualification BA/BSc/HND Experience 8 years Location Nairobi Job Field Media / Advertising / Branding  Senior Communications Officer to lead our communications strategy, focusing on scientific, climate, and nature restoration initiatives. The ideal candidate will play a pivotal role in enhancing our brand presence, driving engagement, and conveying the impact of our work on preserving and restoring natural ecosystems. This position requires a blend of communications expertise, strategic thinking, and a deep understanding of climate, nature restoration, and scientific topics...
Read more

Project Director at LVCT Health

LVCT Health is an indigenous Kenyan non-governmental and not-for-profit organization established in 2001. We are driving Kenya towards HIV prevention, with an ultimate goal of reducing HIV infections to zero. We offer integrated HIV services through development of models that are scaled up to the national models. We also carry out sexual and reproductive ...   Project Director Job Type Full Time Qualification MBA/MSc/MA Experience 7 - 10 years Location Kiambu Job Field Medical / Healthcare  Job purpose The Project Director will be responsible for providing overall strategic and technical oversight to the Dhibiti Project in Central region. This includes responsibility for the technical, monitoring and evaluation and financial and operations components of the project. S/he will work closely with the Program Director and other directors/managers to ensure adherence to technical and contractual requirements of the grant, achievement of targets and project alignment to institutiona...
Read more