Clinical Research Quality Assurance Manager

2 weeks ago

Cape Town, South Africa TASK Full time

**Overall Purpose of the Position**:
The clinical research QA Manager (CR-QAM) will create, maintain and oversee the implementation of the TASK Clinical Quality Management System (QMS) (as applicable to the research sites) comprising of a Quality Assurance Manual (QAM) and a research Site Quality Manual (SQM). The CR-QAM references and implements tasks as described in the QA Manual, Good Clinical Practice (GCP) and TASK Standard Operating Procedures (SOP’s) for day-to-day operations and ensures that the protocols of various studies and the TASK research SQM is implemented by all TASK sites according to the study budgets.

When TASK is taking on the role of a Site Management Organisation (SMO) and / or Sponsor the CR-QAM may get involved and be responsible to perform internal monitoring and / conduct GCP audits at the sites and /or help draft a sponsor monitoring plan, get quotes and contract external monitors (alias CRAs) within the allowed budget and oversee the implementation of the plan as well as other sponsor responsibilities as guided by good clinical practice(GCP) guidelines.

**Key Performance Areas (KPAs) & Responsibilities include, but not limited to**:

- Attending investigator meetings (IM) and/or site initiation visit (SIV) to ensure a thorough knowledge and understanding of study protocols and expected procedures and requirements to identify the possible need for SOP and / or staff training delegation or to implement systems.
- Reading and analysing protocols, SOP’s and manuals.
- Drafting and maintaining the clinical QA Manual, audit tools and research Site Quality Manual (SQM).
- Conducting an annual review of the QA Manual and SQM to analyse the implementation and efficiency of quality and inspection systems and tools and discussing with QA Head (QAH) for final approval and roll out.
- Assisting QAH in drafting TASK SOP’s and policies as required as well as study specific SOP’s / policies when requested.
- Ensuring SOP’s/policies stay current by assisting QAH in reviewing and updating SOP’s within three years after approval date or as processes change or new information becomes available. Managing SOP distribution system and training on them.
- Assisting in identify training needs, implement, coordinate via internal or external programs and maintaining clinical training modules and tracking records to ensure current records for training of staff to prove qualification (non-protocol specific) and competency as per job description and delegated tasks.
- Assisting with coordinating and scheduling / overseeing relevant clinical equipment services when needed and coordinate annual calibration of all clinical equipment by maintaining a system to control, replace, receive, and distribute equipment and calibration certificates between sites and maintain an equipment inventory list per site and TASK overall.
- Assisting in planning and conducting internal /sponsor audits on protocols, systems, procedures and other QA and QC activities and document outcome, analyse data to identify areas for quality improvement (QI).
- Assisting with duties when TASK is delegated as the Sponsor of a trial.
- Assisting with developing monitoring plans according to protocol and budgets.
- Obtaining quotes for external monitoring services.
- Oversight of external monitors - ensure adherence to monitoring plan and timelines, review reports and provide feedback to QAH or sponsors.
- Investigating, overseeing, and managing company and protocol risk mitigation and reporting to QA Head.
- Investigating and overseeing customer / sponsor complaints and non-compliance issues and reporting to QA Head.
- Assisting sites in audit preparations, coordinate and support site during external audits.
- Evaluating audit findings and implement appropriate corrective and preventative actions (CAPA).
- Sharing the workload across the team, offering support to ensure that QA key indicators are monitored, trends are identified and reported. Ensuring regular feedback on overall QA/QC status of TASK to QA Head (QAH).
- Providing professional guidance to team members with complex issues.
- Assisting in drafting clarifying MEMO’s and / or Note to file when needed and ensure record keeping thereof as well as record of any general QA findings.
- Ensuring QA job descriptions are current and implemented by conducting performance appraisals if needed.
- Contributing to hiring decisions, when required.
- Performing miscellaneous job-related duties as assigned.
- Managing the QA and Academy feedback during Friday operational meetings.

**Ideal Requirements**
- Bachelors or BSc degree in any health sciences preferred
- Valid GCP certificate
- Knowledge and experience in Clinical Research will be an advantage
- Two to four years’ working experience as a monitor (CRA) / in a quality assurance role will take preference.
- Three to five years’ experience in a management role within the related pharmaceutical industry or Contract Research Or

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