Open to opportunities

Miranda Naidoo

@mirandanaidoo

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Experienced Lead Data Manager with a strong background in clinical research.

South Africa

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What I'm looking for

I am looking for opportunities that allow me to leverage my clinical research expertise while fostering a collaborative and innovative work environment.

I am an all-rounded, energetic, and ambitious individual with over 7 years of clinical research experience. Currently, I serve as a Lead Data Manager (LDM) on the AMGEN FSP, focusing on oncology and hematology studies. My role involves independently managing data management services for global clinical research projects, leading communication, project execution, and oversight with both internal and external team members. I ensure that customer requirements are met with high standards of care, demonstrating my commitment to excellence in all aspects of my work.

In addition to my role as a Data Team Lead, I mentor and coach other Data Team Leads, sharing my expertise in database lock, early site closure, and final lock phases. My extensive experience includes coordinating clinic flow, quality control, regulatory compliance, and study implementation for numerous HIV vaccine and COVID-19 clinical trials. I possess in-depth knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines, which I apply diligently to ensure compliance and quality in all my projects.

Experience

Work history, roles, and key accomplishments

Current

Data Team Lead (Data Manager)

Current

IQVIA

Jun 2022 - Present (3 years 1 month)

Managed data management services for global clinical research projects, serving as the primary point of contact for customer data management deliverables. Led communication, project execution, and oversight with internal and external teams to ensure quality database development, maintenance, and close-out activities.

Data Management Project Management Clinical Research Database Development Quality Control Stakeholder Engagement Regulatory Compliance Mentorship Oncology

Clinical Trial Coordinator

CAPRISA - Centre for the AIDS Programme of Research in South

Nov 2020 - May 2022 (1 year 6 months)

Coordinated all regulatory activities for HIV Vaccine and COVID-19 studies, including submitting protocols and consent documents for ethics/IRB approval. Ensured compliance with GCP standards and managed logistical and scheduling issues.

Regulatory Affairs Clinical Trials GCP Data Management Quality Control Datafax Compliance

Quality Control Officer

CAPRISA - Centre for the AIDS Programme of Research in South

Aug 2018 - Oct 2020 (2 years 2 months)

Performed quality control on participant files, informed consent forms, and electronic data capture across multiple studies. Ensured accurate data entry from source notes and managed query resolution to minimize data discrepancies.

Quality Control Data Entry Data Management Query Resolution

Intern

CAPRISA Centre for the AIDS Programme of Research in South

Jan 2018 - Dec 2018 (11 months)

Provided administrative support, including managing participant scheduling and reimbursements. Assisted with updating and maintaining investigator regulatory files and compiling submissions to regulatory bodies.

Administrative Support Regulatory Affairs Quality Control Datafax Regulatory Submissions Clinical Research

Consultant

Invotech Innovation Technology Business Incubator

Feb 2018 - Dec 2018 (10 months)

Assisted with screening new clients, administering psychological assessments, and inducting new clients into the incubator. Reviewed quarterly reports and helped manage the TIA Seed Fund.

Business Incubation Reports Client Induction Administrative Support Stakeholder Engagement

Business Support Officer

Invotech Innovation Technology Business Incubator

Jun 2014 - Dec 2017 (3 years 6 months)

Managed general administration, mentored clients, and identified service providers. Planned and organized workshops, trainings, and presentations, while also screening new clients and managing logistics.

Administrative Support Mentoring Event Planning Stakeholder Engagement Project Management Program Coordination Contract Facilitation Monitoring and Evaluation Business Development

Subconsultant

Lima Rural Development Foundation

Feb 2014 - Mar 2014 (1 month)

Reviewed site plans of Municipalities regarding the CWP and wrote socio-economic analyses for various sites. Developed detailed village and site plans for Municipalities.

Report Writing Community Work Programme Rural Development Project Analysis Research Documentation

Subconsultant

Ithunga Development

Feb 2014 - Mar 2014 (1 month)

Reviewed CWP monthly progress and close-out reports, consolidating various site reports into a single comprehensive report. Ensured accurate and timely reporting for development projects.

Reports Data Consolidation Progress Reports Project Management Community Work Programme Data Analysis Documentation Administrative Support Communication

Tutor

University of Kwa-Zulu Natal

Feb 2012 - Oct 2013 (1 year 8 months)

Provided tutoring services to students and was responsible for marking assignments, class activities, practicals, and examinations. Supported student learning and academic assessment.

Tutoring Academic Support Education Teaching Assessments Communication

Administration Clerk

Zululand Engineering

Dec 2011 - May 2014 (2 years 5 months)

Performed data capturing, managed creditors and remittances, and handled filing and letter writing. Provided general administrative support, including answering phones and using MS Word and Excel.

MS Word MS Excel Creditor Management Remittances Administrative Support Pastel & Payroll

Education

Degrees, certifications, and relevant coursework

University of Kwa-Zulu Natal Pietermaritzburg

Masters, Education & Development

Obtained a Master's degree in Education & Development. The curriculum covered educational theories and developmental practices.

University of Kwa-Zulu Natal Pietermaritzburg

Bachelor of Social Science Honours, Psychology

Completed a Bachelor of Social Science Honours degree with a specialization in Psychology. This program deepened understanding of psychological principles and research.

St Catherine’s High School Empangeni

High School Diploma, General Studies

Grade: English Home Language (74), Afrikaans First Additional Language (73), Mathematics (82), Life Orientation (75), Geography (88), History (83), Physical Sciences (57)

Activities and societies: Certificate for Toastmasters International Youth Leadership & Communication Course (2007). Merit Awards in Mathematics and Geography (2007 and 2008). Rhind Floating Trophy for Geography (2008). Sports House Captain (2008). Awarded the Cyril Morillion Floating Trophy for the most public-spirited Matric student (2008).

Completed secondary education with strong performance in English Home Language, Afrikaans First Additional Language, Mathematics, Life Orientation, Geography, History, and Physical Sciences.