Vacancy Details
Employer: Kontak Recruitment
Quality Manager | Clinical Research Operations (JB4805)
Remote, for applicants living in South Africa
Market-Related
Duration: Permanent
We are seeking a highly skilled Quality Manager with expertise in clinical research operations to uphold and enhance the quality of our client's clinical trials. The ideal candidate will have a background as a Clinical Research Associate (CRA) with experience in pharmaceutical companies or Contract Research Organizations (CROs). This role will involve working closely with clinical operations and regulatory teams to ensure compliance with Good Clinical Practice (GCP) and relevant industry standards.
This is a remote-based position with occasional travel to clinical trial sites and partner locations.
Minimum Requirements:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (required).
Advanced degree (Master’s or PhD) or equivalent experience in clinical research or pharmaceutical quality management (preferred).
Minimum of 5 years of experience in clinical research, focusing on quality assurance or quality management.
Experience as a CRA, ideally within a pharmaceutical company or CRO.
Strong familiarity with Good Clinical Practice (GCP), ICH guidelines, and regulatory compliance standards.
Proven experience auditing clinical trial sites and implementing corrective actions.
Strong communication, analytical, and problem-solving skills.
Ability to work collaboratively in cross-functional teams.
Duties and Responsibilities:
Clinical Trial Quality Oversight:
Implement and manage the quality management system (QMS) within clinical operations.
Ensure adherence to GCP, Standard Operating Procedures (SOPs), and regulatory requirements.
Oversee data quality from clinical trials, ensuring accuracy and consistency.
Conduct quality control audits of trial sites, identifying gaps and recommending corrective actions.
Compliance and Regulatory Management:
Ensure compliance with local and international regulatory standards (ICH-GCP, FDA).
Collaborate with regulatory bodies, ensuring proper documentation of clinical research activities.
Provide guidance on quality and compliance issues to research teams and senior management.
Process Improvement and Risk Management:
Identify risks in clinical trial processes and develop mitigation strategies.
Lead initiatives to improve process efficiency and maintain high-quality standards.
Conduct root cause analysis and implement corrective and preventive actions (CAPA).
Training and Development:
Develop and deliver quality assurance training for clinical staff.
Ensure team members are updated on regulatory changes and quality standards.
Mentor junior staff, especially CRAs, in quality assurance practices.
Collaboration with Key Stakeholders:
Coordinate with clinical operations, data management, regulatory affairs, and project management teams.
Collaborate with external partners to ensure outsourced research adheres to quality standards.
Audit Preparation and Reporting:
Lead internal and external audits, including sponsor audits and regulatory inspections.
Present audit reports, quality metrics, and compliance findings to senior management.
Address audit findings with timely corrective actions.
Please do not apply using Scanned CVs, no supporting documentation is required at this point, this will be requested later.
IMPORTANT: We specialize in specific niche fields. Regret that we are unable to provide assistance for any fields outside of this scope. Fields can be viewed on our website.
Kontak Recruitment Disclaimer:
Equal opportunity: All backgrounds are welcomed, with no bias. All are considered based on requirements.
Job specifics: Requirements mirror advertisement, duties may adjust for client needs.
Fair process: Fair assessment, only shortlisted candidates contacted due to volume.
Privacy: Data processed as per Privacy Policy. By applying, you agree to data handling. We safeguard applicant info.
Candidate verification: Candidates selected by the client are verified. False info may disqualify or end employment via the client.
Offer clarity: Advert is not a binding offer. Written offers based on pre-employment conditions.
No direct link: Advert is not tied to Kontak Recruitment. We assist in the employment process ONLY.
Applicant Responsibility: Upon applying, confirmation of receipt for a specific advert is given. If no confirmation is received, you must verify with Kontak Recruitment.
Candidate Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (required).
Advanced degree (Master’s or PhD) or equivalent experience in clinical research or pharmaceutical quality management (preferred).
Minimum of 5 years of experience in clinical research, focusing on quality assurance or quality management.
Experience as a CRA, ideally within a pharmaceutical company or CRO.
Strong familiarity with Good Clinical Practice (GCP), ICH guidelines, and regulatory compliance standards.
Proven experience auditing clinical trial sites and implementing corrective actions.
Strong communication, analytical, and problem-solving skills.
Ability to work collaboratively in cross-functional teams.
17 people have applied for this job. 674 people have viewed this job.
About Kontak Recruitment
Kontak Recruitment is a Pastel Certified Recruiter which specializes in the recruitment of personnel on all career levels including the placement of temporary, contract as well as permanent staffing. We enjoy the personalized approach with regards to out candidates focusing on their needs and requirements as well as a personalized approach with our clients in delivering an excellent service.
Kontak Recruitment conducts business in an ethical and honest manner. We aim at building long term relationships that are to the mutual benefit of all parties. We offer a responsible and personalized service to clients and candidates. We encourage an employment environment that provides equal opportunities for all employees. All positions and applications remain confidential protecting the rights and interests of both the client and the candidates.
Our core focus is delivering a staffing solution in the niche fields of Pastel Consultants,finance as well as office support. As part of this service offering we include extensive reference and qualification checks as well as a criminal and credit check. Our focus is quality and we will present the most efficient and integrated ways of satisfying the skills need within the company.
Permanent staff placements – We strive to find the right fit and providing support to client and candidate during the first three months of the employment.
Temporary and Contract placements – We offer immediate access to staff on all levels on a flexible basis. Kontak Recruitment administers the payroll and all statutory returns.
Terms and Conditions Available on Request
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