Overall Purpose of the Position:
As a Clinical Trial Quality Assurance Manager (QAM), you will play a pivotal role in ensuring the integrity, compliance, and quality of our clinical trials, including when TASK takes on the role and responsibilities of Sponsor in quality oversight and management of a clinical trial on behalf of a sponsor / grant studies. You will collaborate closely with cross-functional teams to set -up, implement, oversee, and maintain quality assurance processes and systems throughout the lifecycle of clinical trials, from study set -up to closeout.
Key Performance Areas (KPAs) & Responsibilities include, but not limited to:
• Assisting with sponsor oversight when TASK is taking on sponsor responsibilities: budgeting for contracting Clinical Research Associate's (CRA), performing study risk analysis together with the appointed principal investigator (PI), drafting / reviewing monitoring plans, collating quotes from contracted CRA's and CRA selection according to budget allowance, setting up service level agreements with appointed CRA and overseeing the execution of the monitoring plan by reviewing and approving follow up letters and sponsor reports and electronic Trial master file maintenance by CRA, reviewing CRA invoices and reconcile keeping within the set budget from first visit to last visit.
• Developing, implementing, reviewing, and maintaining clinical quality assurance procedures, documents and systems to ensure compliance with clinical trial regulatory requirements, industry standards, and company policies (example TASK as Sponsor, TASK QA Manual; Site Quality Manual; TASK SOPs, Project clinical monitoring plan).
• Conducting risk assessments, study, and system audits to identify areas for improvement and ensuring adherence to clinical trial protocols, SOPs, regulatory guidelines, Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) guidelines.
• Providing feedback, guidance and support to study teams, sponsor, and project funders on quality assurance in general.
• Creating and evaluating policies and procedures for compliance with applicable clinical trial regulations / guidelines and providing recommendations to management for continuous process improvements.
• Supporting the general start-up functions around setting up a clinical trial at an approved research site – overseeing training requirements for staff to work on the trial, assisting PI's with creation of delegation log and assigning tasks, attending, and presenting at site initiation visits.
• Performing internal inspections and monitoring activities at clinical trial sites to assess compliance with study protocols, GCP and regulatory requirements and formally report on observations and follow up until resolved.
• Investigating deviations, non-conformances, and quality incidents, assisting with major incident report investigations, root cause analysis, and implementing corrective and preventative actions where needed together with the research sites.
• Ensuring the follow-up of major and critical audit findings (internal and external audits) to ensure that appropriate actions have been taken and have adequately resolved the issues identified and ensure the documentation and reporting.
• Assisting in external audit / inspection preparations, attending audits / inspections, as needed.
• Ensuring the Quality Assurance shared drive is maintained and up to date to reflect the status of QA responsibilities for example active studies, audits, templates, manuals, SOPs, tools used etc.
• Organizing and delivering training to other teams to improve and support quality and compliance.
• Collaborating with external vendors and partners to ensure the quality and integrity of outsourced activities, such as central laboratory testing and sample analysis.
• May be requested to assist with central temperature monitoring system (CTMS) oversight and staff SOP and training oversight platform (KRONUS)
Ideal Requirements
• Tertiary qualification in any health sciences preferred.
• Strong knowledge and 2-4 years of work experience in local and international regulations and clinical research quality standards governing clinical trials, including GCP, GCLP, FDA and EU, enabling candidate to work independently, will take preference.
• Demonstrated experience in clinical trial project management, CRA oversight and management, implementing and overseeing clinical quality assurance systems, clinical CRA budgets and assessing processes and identifying needs within clinical trials, is essential.
• Managing clinical quality processes of multiple trials and / or at multiple sites.
• Proficient in MS Office, e.g. Word, Excel and PowerPoint, Microsoft 360.
• Proven background in working in the clinical research industry.
• Valid driver's license.
• Valid ICH and SA GCP certification.
Key Personal Inherent Characteristics
• Ability to work independently and collaboratively in a fast-paced, multidisciplinary (international) clinical research environment.
• Excellent communication skills – building and maintaining effective interpersonal relationships on various levels with diverse groups of coworkers, managers and clients.
• Ability to be adaptable and flexible in a forever changing environment.
• Good problem solving, risk analysis and negotiation skills.
• Self-starter – can work independently and show initiative.
• Effective people and system management, organization, communication, team orientation, and leadership skills.
• Ability to manage multiple projects.
Details: Area: Parow, Cape Town
Contract Type: 24 Months Fixed Term (with potential to extend based on operational requirements) Applications Close: 21 June 2024
Please indicate in your application that you are applying for the above-mentioned position.
If you have not received a response within one month, your application was most likely unsuccessful.
TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.
Meeting our employment equity goals will be acknowledged during the recruitment process.
By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa's Protection of Personal Information Act and understand your rights and obligations under this Act.
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