プロフィール詳細

プロジェクトを作成

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Timeo M.に依頼

United Kingdom

Clinical Trial Manager. Provide clinical research expertise for all phase (I to III) trials globally

プロフィール概要

I am an experienced Clinical Trial Manager with extensive expertise in the planning, coordination, and delivery of clinical research across the pharmaceutical, biotechnology, and healthcare sectors. Throughout my career, I have successfully managed complex, multi-centre clinical trials from study start-up through close-out, ensuring compliance with ICH-GCP, regulatory requirements, study protocols, and quality standards while delivering projects on time and within budget. My expertise spans the full clinical trial lifecycle, including study start-up, site selection and activation, vendor and CRO management, Trial Master File (TMF) oversight, risk-based trial management, project planning, budget management, clinical operations, inspection readiness, and cross-functional stakeholder coordination. I have worked collaboratively with investigators, sponsors, ethics committees, regulatory authorities, data management, pharmacovigilance, medical affairs, and external vendors to ensure the successful execution of clinical research programmes. I have a strong track record of leading multidisciplinary teams, managing global and regional clinical studies, developing study documentation, reviewing essential trial documents, monitoring study progress through key performance indicators, identifying operational risks, and implementing effective mitigation strategies to maintain study quality and timelines. As a consultant, I support pharmaceutical companies, biotechnology firms, CROs, academic institutions, digital health companies, and research organisations that require flexible clinical operations expertise. My consulting services include: Clinical trial project management Clinical operations strategy and oversight Study start-up planning and execution Vendor and CRO selection and management Trial Master File (TMF) review and optimisation GCP compliance and quality management SOP development and review Clinical research documentation review Risk management and study governance Inspection and audit readiness Clinical operations process improvement Research project coordination Clinical trial feasibility assessments Training and mentoring of clinical research professionals In addition to operational leadership, I provide strategic advice to organisations seeking to improve the efficiency, quality, and regulatory compliance of their clinical research programmes. I am particularly interested in supporting emerging biotech companies and research teams that require experienced clinical operations leadership on a flexible or project-based basis. I am recognised for my analytical thinking, attention to detail, collaborative leadership style, and ability to solve complex operational challenges while maintaining the highest standards of patient safety, data integrity, and regulatory compliance. I welcome opportunities to collaborate on clinical research projects globally, whether providing short-term specialist support, ongoing project management, or strategic consulting throughout the clinical development process.

専門分野

• ☆ Data Analysis
• ☆ Data Collection
• ☆ Data Management
• ☆ Leadership
• ☆ Clinical Trials
• ☆ Clinical Trial Design
• ☆ Infectious Disease
• ☆ Pulmonology/Respiratory Disease
• ☆ Tuberculosis
• ☆ Project Management
• ☆ Risk Management

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Technical Writing

Research Scientific and Technical Research, Systematic Literature Review

Consulting Digital Strategy Consulting, Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Data Processing, Data Insights

職務経験

University of Oxford

- 現在

Clinical Trial Manager

University of Oxford

10月 2023 - 6月 2026

Clinical Trials Coordinator

Kamuzu University of Health science (KUHeS)

8月 2022 - 9月 2023

Clinical Trials Coordinator

Malawi Liverpool Welcome research program

12月 2020 - 7月 2022

Research Clinical Officer

Dignitas International Organisation

9月 2015 - 12月 2017

学歴

MSc in Clinical Trials (London School of Hygiene and Tropical Medicine (LSHTM))

University Of London

12月 2020 - 12月 2023

BSC in Public Health

ShareWorld University

1月 2016 - 11月 2018

Diploma in Clinical Medicine

Malawi Adventist University ( Malamulo College of Health Sciences)

4月 2012 - 1月 2013

認定資格

• PRINCE2 Practitioner- Project management

  PeopleCert

  4月 2026 - 現在

• Essential guide on grant applications

  NIHR

  4月 2024 - 現在

• Leadership and Management in health

  University of Washington

  1月 2021 - 現在

• Risk Management

  Malawi Liverpool Wellcome trust

  1月 2021 - 現在

• CH-GCP (E6 R3)

  NIHR, University of Oxford

  1月 2026 - 12月 2026

出版物

JOURNAL ARTICLE

Burke RM, Nyirenda SK, Mtenga T, Twabi HH, Joekes E, Walker NF, Nyirenda R, Gupta-Wright A, Nliwasa M, Fielding K, et al.(2025). Enhanced Tuberculosis Diagnosis With Computer-aided Chest X-ray and Urine Lipoarabinomannan in Adults With HIV Admitted to Hospital (CASTLE Study): A Cluster Randomized Trial . Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

Timeo Mtenga, Rachael M Burke, Saulos K Nyirenda, Hussein H Twabi, Elizabeth Joekes, Naomi F Walker, Rose Nyirenda, Ankur Gupta-Wright, Marriott Nliwasa, Katherine Fielding, et al. (2024). Enhanced Tuberculosis Diagnosis With Computer-aided Chest X-ray and Urine Lipoarabinomannan in Adults With HIV Admitted to Hospital (CASTLE Study): A Cluster Randomized Trial . Clinical Infectious Diseases.

Gerber F, Semphere R, Lukau B, Mahlatsi P, Mtenga T, Lee T, Kohler M, Glass TR, Amstutz A, Molatelle M, et al.(2024). Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: Protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi . PloS one.

Felix Gerber, Robina Semphere, Blaise Lukau, P.A. Mahlatsi, Tristan Lee, Michaela Kohler, Tracy R. Glass, Alain Amstutz, Mamello Molatelle, et al., Timeo Mtenga (2023). Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi . PLOS ONE.

Timeo Mtenga (2023). The impact of Covid-19 on Tuberculosis (TB) care among admitted medical patients in Zomba, Malawi: a cross-sectional study . The Global Health Network Collections.

PREPRINT

Gerber F, Semphere R, Lukau B, Mahlatsi P, Mtenga T, Lee T, Kohler M, Glass TR, Amstutz A, Molatelle M, et al.(2023). Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi .

RESEARCH TECHNIQUE

Timeo Mtenga, Oliver FitzGerald, Laura Coates, Stephen R. Pennington, Teresa Grohmann, Michaela Koehm, Rudolf Horvath, Mari Hoff, Burkhard Moller, Theodoros Dimitroulas The protocol of a patient-driven on-line prospective European observational cohort aiming to determine risk factors for the development of psoriatic arthritis (PsA) amongst people living with psoriasis:.