Tahiya Zaman

As the Research Quality & Governance Manager of the trust I lead the Quality Department in the RD&I department.

I guide, support & implement QMS processes to ensure GCP compliance for all research activity being conducted at the trust.

Achievements in my role so far:

• Quality Management Classroom Training delivered to the whole RD&I department
• Written, Reviewed & Approved 4 Quality Management SOPs & 11 Research Delivery SOPs.
• Enhanced the SOP training process to make it streamlined for Research Delivery Teams to stay compliant
• CAPA stipulated to address ongoing GCP compliance issues amongst PIs & study teams
• Completing a L3 Teaching Award
• Governed & Chaired regular Quality Management Review Meetings

Working closely with study managers across several global teams to effectively run: start-up, close out and ongoing clinical trials within the clinical operations function.

Responsibilities of the role included:

• Supporting vendors & functions stay GCP compliant by sharing and recording mandatory training on all relevant study documents.
• Performing regular QC activities of the TMF and guiding other functions to perform their QC activities per SOP guidelines.
• Presenting TMF metrics, documentation updates, and vendor set up status in wider team meetings.
• Document development & management of documents such as: Storyboard & TMF Plan.
• Reviewing & amending documents such as ICFs per template & drug AE updates.
• Using accession numbers with central lab applications to track sample activities.
• Tracking of study invoices and purchase order updates ensuring that relevant contracts and budget information are up to date.
• Performing data management activities e.g. producing open query reports to feedback to the wider team

I was promoted from a clinical trial’s assistant to an administrator/coordinator role to assist breast oncology and haematology studies.

Responsibilities of the role included:

• Working with consultants and Principal Investigators to coordinate and setup audits.
• Producing data sharing agreements and completing & submitting contracts to sponsor.
• Organising SIVs to initiate recruitment to studies.
• Reviewing CRFs for internal & external audits
• Feeding back figures & recruitment progress in governance meetings.

Working predominantly on a Breast Cancer Predict trial to determine the risk of breast cancer in women.

Responsibilities of the role included:

• Working with a multi-disciplinary team including medical oncologist and principal investigator to recruit participants on to the trial
• Calculating risk scores using a software program and mammogram information using patient records
• Working with family history clinics and research nurses to gather data from pedigrees and drug history to provide an accurate assessment of breast cancer risk.