Validations Manager

Location: Africa

Job ID: 00013

Department: Global Evidence and Access

Job Description

In this position, you will own the operational execution of clinical validation studies at all assigned international sites. Reporting to the Evidence & Access Lead, where s/he sets strategy and owns external relationships, your role as the Validations Manager will be to design, supervise and manage analytical studies, feasibility studies, clinical trials and implementation studies from conception to finalization. Core requirements are to ensure protocols are followed, data are clean and audit-ready, blinding is enforced, reagents and samples are tracked, and every step from site initiation visit (SIV) to database lock is documented to a standard that will withstand WHO PQ and CE-IVDR regulatory scrutiny. The successful candidate will co-supervise a clinical research associate, responsible for quality clinical outcomes and site electronic Trial Master File (eTMF) support.

Responsibilities

  • Managing multi-centre diagnostic trials and studies, with the primary focus on feasibility, evaluation and demonstration studies that enable WHO review and regulatory approval
  • Primary site contact for all protocol questions, reagent issues, logistics coordination, and reporting
  • With partner sites, coordinate study ethics and regulatory submissions
  • Lead site feasibility assessments, prepare SIV and training packages, work closely with collaborators and study sponsors, conduct monitoring visits, monitor enrolment against targets
  • Coordinate preparation and characterisation of evaluation sample panels: reference strain sourcing, aliquot storage, periodic quality checks
  • Building capacity at investigational sites, providing ongoing training and monitoring (including travel to sites) to review study progress, ensure protocol compliance and data integrity
  • Setting up and maintaining TMF for clinical trials as well as helping sites establish Investigational Site Files – ethics approvals, site agreements, SIV records, training logs, monitoring reports, protocol amendments, correspondence
  • Writing of reports, publications and scientific presentations (incl. travel for presentations)
  • Ensure site activities comply with ICH-GCP E6 (R3) and applicable local requirements; ISO 20916:2019 and ICMR-CDSCO protocols impose equivalent quality obligations

Requirements

  • 3–6 years in IVD or clinical diagnostics research with hands-on site-level study conduct responsibility
  • BSc/MSc in biomedical sciences, clinical microbiology, medical laboratory science, or tropical medicine. Advanced degree preferable.
  • Practical understanding of diagnostic accuracy study design: sensitivity/specificity, reference standard limitations, blinding requirements
  • Scientific and/or technical understanding of the design and development of diagnostics
  • Experience and track record of planning and conducting clinical studies
  • Relevant experience working in low and middle-income countries
  • Ability to multitask and work in a rapidly changing environment, across different time zones
  • Ability to work collaboratively in teams of multi-cultural backgrounds; effective communication
  • GCP certification current or obtainable within 3 months of hire; TMF documentation experience
  • ISO 20916:2019 or WHO PQ/CE-IVDR submission-quality study experience; prior CRA or clinical monitor experience at a CRO or academic research organisation
  • Strong written English

Essential — Africa Instance (additional)

  • Prior work in sub-Saharan Africa or Middle East health system; knowledge of ≥1 African regulatory authority ethics and device evaluation requirements
  • Strong technical knowledge of TB, HIV, STIs and hepatitis diagnostics and laboratory standards

Essential — LATAM Instance (additional)

  • Portuguese and/or Spanish professional proficiency
  • Direct experience coordinating studies in LATAM: CONEP/CEP ethics, ANVISA import processes, or REBEC registry
  • Familiarity with arboviral, tropical disease diagnostics (Dengue, Chikungunya, Malaria and emerging pandemic threats) and laboratory standards

How to Apply

Closing date for applications: 10 July 2026
Interested candidates should submit a CV and a cover letter, specifying the position (Africa or LATAM) being applied for, and statement on your right of work in country of choice

Experience

  • 3-6

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PLEASE READ THIS NOTICE CAREFULLY. IT APPLIES TO ALL PERSONS WHO VIEW THIS WEBSITE. THESE MATERIALS ARE NOT DIRECTED AT OR INTENDED TO BE ACCESSED BY PERSONS LOCATED OUTSIDE INDIA. THESE MATERIALS ARE BEING MADE AVAILABLE ON THIS WEBSITE TO COMPLY WITH SECURITIES AND EXCHANGE BOARD OF INDIA (ISSUE OF CAPITAL AND DISCLOSURE REQUIREMENTS) REGULATIONS, 2018, AS AMENDED.

Investors should read the Draft Red Herring Prospectus and seek professional advice before taking any action.

IMPORTANT: You must read and agree with the terms and conditions of the following disclaimer before continuing.

The following disclaimer applies to the draft red herring prospectus of Molbio Diagnostics Limited (the “Company”) dated August 22, 2025 (the “Draft Red Herring Prospectus”) filed with the Securities and Exchange Board of India (“SEBI”) and hosted on this website in connection with the initial public offering of the equity shares (“Equity Shares”) of the Company (the “Offer”). You are advised to read the following notice carefully before accessing the Draft Red Herring Prospectus. In accessing the Draft Red Herring Prospectus, you agree to be bound by the following terms and conditions, including any modifications to them from time to time.

Access to the Draft Red Herring Prospectus does not constitute a recommendation by the Company, the members of the Syndicate (as defined in the Draft Red Herring Prospectus) or any of their respective affiliates or any other person to subscribe to the Equity Shares offered in the Offer.

The Draft Red Herring Prospectus is directed at, and is intended for distribution to, and use by, residents of India only. The information in this portion of our website, including the Draft Red Herring Prospectus, is not for publication or distribution, directly or indirectly, in or into the United States. The contents of the Draft Red Herring Prospectus is for your information only, and you acknowledge that access to the Draft Red Herring Prospectus is intended for use by you only and you agree not to forward the Draft Red Herring Prospectus on to any other person, internal or external to your company, in whole or in part, or otherwise provide access via e-mail or otherwise to any person. Any person into whose possession the DRHP comes is required to inform himself or herself about and to observe any such restrictions. BRLMs and/or its affiliates or their respective directors, officers and employees are not soliciting any action based on any of the information contained on this website, including the DRHP, and such information should not be construed as an offer, or invitation or offer to sell or the solicitation of any offer to buy or subscribe for or purchase any security. No part of the contents of the Draft Red Herring Prospectus shall be copied or duplicated in any form by any means or redistributed.

The Draft Red Herring Prospectus has been hosted on this website as prescribed under Regulation 26(1) of the Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) Regulations, 2018, as amended. Our Company has taken all necessary steps to ensure that the contents of the Draft Red Herring Prospectus as appearing on this website are identical to the Draft Red Herring Prospectus filed with the SEBI. You are reminded that documents transmitted in electronic form may be altered or changed during the process of transmission and consequently, neither the Company nor the BRLMs any of its affiliates accepts any liability or responsibility whatsoever in respect of alterations or changes which have taken place during the course of transmission of electronic data.

The Draft Red Herring Prospectus does not constitute an offer to sell or an invitation to subscribe to the securities offered in any jurisdiction to any person to whom it is unlawful to make an offer or invitation in such jurisdiction and is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where (a) distribution or use of such information would be contrary to law or regulation; or (b) the Company or any of its affiliates would by virtue of such distribution become subject to new or additional registration, licensing or other regulatory requirements. The Equity Shares offered in the Offer have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“U.S. Securities Act”) or any state securities laws in the United States, and unless so registered, may not be offered or sold within the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and in accordance with any applicable U.S. state securities laws. Accordingly, the Equity Shares are being offered and sold only outside the United States in ‘offshore transactions’ in compliance with Regulation S under the U.S. Securities Act and the applicable laws of the jurisdictions where such offers and sales are made.

Any person into whose possession the Draft Red Herring Prospectus comes is required to inform himself or herself about and to observe any such restrictions. Neither the Company, BRLMs nor any of its affiliates is soliciting any action based on the Draft Red Herring Prospectus, and it should not be construed as an offer to sell or the solicitation of an offer to buy any securities. Potential investors should not rely on the Draft Red Herring Prospectus for any investment decision.

Any decision on whether to invest in the equity shares described in the Draft Red Herring Prospectus may only be made after a red herring prospectus has been filed with the Registrar of Companies, Goa, Daman and Diu at Panaji and the SEBI and must be made solely on the basis of such red herring prospectus, as there may be material changes in the red herring prospectus compared to the Draft Red Herring Prospectus. Invitations to subscribe to or purchase the equity shares in the Offer will be made only pursuant to the red herring prospectus if the recipient is in India or the preliminary offering memorandum for the Offer, which comprises the red herring prospectus and the preliminary international wrap for the Offer, if the recipient is outside India. No person outside India is eligible to Bid for equity shares in the Offer unless that person has received the preliminary offering memorandum for the Offer, which shall contain the selling restrictions for the Offer outside India.

Any potential investor should note that investment in equity shares involves a high degree of risk and for details relating to such risk, please see the section titled “Risk Factors” of the red herring prospectus, when available.

Neither the Company, BRLMs, nor any of its affiliates will be responsible for any loss or damage that could result from interception and interpretation by any third parties of any information being made available to you through this website. The Company and its affiliates cannot and do not guarantee the accuracy, timeliness or completeness of the information being made available to you in the Draft Red Herring Prospectus beyond the date of the Draft Red Herring Prospectus. The information contained in the Draft Red Herring Prospectus may not be updated since its original publication date and may not reflect the latest updates. The Company and its affiliates will not be responsible for any loss to any person or entity caused by any shortcoming, defect or inaccuracy which may have inadvertently or otherwise crept into the website. Neither the Company, any of its affiliates nor their directors, officers and employees will be liable or have any responsibility of any kind for any loss or damage that you incur in the event of any failure or disruption of this website, or resulting from the act or omission of any other party involved in making this website or the data contained therein available to you, or from any other cause relating to your access to, inability to access, or use of the website or these materials.

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The documentation contained in these pages is posted solely to comply with Indian legal and regulatory requirements. Making the information contained herein available in electronic format does not constitute an offer to sell, the solicitation of an offer to buy, or a recommendation to buy or sell securities of the Company in the United States or in any other jurisdiction, including without limitation, India.

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Legal Disclaimer – Important

PLEASE READ THIS NOTICE CAREFULLY. IT APPLIES TO ALL PERSONS WHO VIEW THIS WEBSITE. THESE MATERIALS ARE NOT DIRECTED AT OR INTENDED TO BE ACCESSED BY PERSONS LOCATED OUTSIDE INDIA. THESE MATERIALS ARE BEING MADE AVAILABLE ON THIS WEBSITE TO COMPLY WITH SECURITIES AND EXCHANGE BOARD OF INDIA (ISSUE OF CAPITAL AND DISCLOSURE REQUIREMENTS) REGULATIONS, 2018, AS AMENDED.

Investors should read the Draft Red Herring Prospectus and seek professional advice before taking any action.

IMPORTANT: You must read and agree with the terms and conditions of the following disclaimer before continuing.

The following disclaimer applies to the draft red herring prospectus of Molbio Diagnostics Limited (the “Company”) dated August 22, 2025 (the “Draft Red Herring Prospectus”) filed with the Securities and Exchange Board of India (“SEBI”) and hosted on this website in connection with the initial public offering of the equity shares (“Equity Shares”) of the Company (the “Offer”). You are advised to read the following notice carefully before accessing the Draft Red Herring Prospectus. In accessing the Draft Red Herring Prospectus, you agree to be bound by the following terms and conditions, including any modifications to them from time to time.

Access to the Draft Red Herring Prospectus does not constitute a recommendation by the Company, the members of the Syndicate (as defined in the Draft Red Herring Prospectus) or any of their respective affiliates or any other person to subscribe to the Equity Shares offered in the Offer.

The Draft Red Herring Prospectus is directed at, and is intended for distribution to, and use by, residents of India only. The information in this portion of our website, including the Draft Red Herring Prospectus, is not for publication or distribution, directly or indirectly, in or into the United States. The contents of the Draft Red Herring Prospectus is for your information only, and you acknowledge that access to the Draft Red Herring Prospectus is intended for use by you only and you agree not to forward the Draft Red Herring Prospectus on to any other person, internal or external to your company, in whole or in part, or otherwise provide access via e-mail or otherwise to any person. Any person into whose possession the DRHP comes is required to inform himself or herself about and to observe any such restrictions. BRLMs and/or its affiliates or their respective directors, officers and employees are not soliciting any action based on any of the information contained on this website, including the DRHP, and such information should not be construed as an offer, or invitation or offer to sell or the solicitation of any offer to buy or subscribe for or purchase any security. No part of the contents of the Draft Red Herring Prospectus shall be copied or duplicated in any form by any means or redistributed.

The Draft Red Herring Prospectus has been hosted on this website as prescribed under Regulation 26(1) of the Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) Regulations, 2018, as amended. Our Company has taken all necessary steps to ensure that the contents of the Draft Red Herring Prospectus as appearing on this website are identical to the Draft Red Herring Prospectus filed with the SEBI. You are reminded that documents transmitted in electronic form may be altered or changed during the process of transmission and consequently, neither the Company nor the BRLMs any of its affiliates accepts any liability or responsibility whatsoever in respect of alterations or changes which have taken place during the course of transmission of electronic data.

The Draft Red Herring Prospectus does not constitute an offer to sell or an invitation to subscribe to the securities offered in any jurisdiction to any person to whom it is unlawful to make an offer or invitation in such jurisdiction and is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where (a) distribution or use of such information would be contrary to law or regulation; or (b) the Company or any of its affiliates would by virtue of such distribution become subject to new or additional registration, licensing or other regulatory requirements. The Equity Shares offered in the Offer have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“U.S. Securities Act”) or any state securities laws in the United States, and unless so registered, may not be offered or sold within the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and in accordance with any applicable U.S. state securities laws. Accordingly, the Equity Shares are being offered and sold only outside the United States in ‘offshore transactions’ in compliance with Regulation S under the U.S. Securities Act and the applicable laws of the jurisdictions where such offers and sales are made.

Any person into whose possession the Draft Red Herring Prospectus comes is required to inform himself or herself about and to observe any such restrictions. Neither the Company, BRLMs nor any of its affiliates is soliciting any action based on the Draft Red Herring Prospectus, and it should not be construed as an offer to sell or the solicitation of an offer to buy any securities. Potential investors should not rely on the Draft Red Herring Prospectus for any investment decision.

Any decision on whether to invest in the equity shares described in the Draft Red Herring Prospectus may only be made after a red herring prospectus has been filed with the Registrar of Companies, Goa, Daman and Diu at Panaji and the SEBI and must be made solely on the basis of such red herring prospectus, as there may be material changes in the red herring prospectus compared to the Draft Red Herring Prospectus. Invitations to subscribe to or purchase the equity shares in the Offer will be made only pursuant to the red herring prospectus if the recipient is in India or the preliminary offering memorandum for the Offer, which comprises the red herring prospectus and the preliminary international wrap for the Offer, if the recipient is outside India. No person outside India is eligible to Bid for equity shares in the Offer unless that person has received the preliminary offering memorandum for the Offer, which shall contain the selling restrictions for the Offer outside India.

Any potential investor should note that investment in equity shares involves a high degree of risk and for details relating to such risk, please see the section titled “Risk Factors” of the red herring prospectus, when available.

Neither the Company, BRLMs, nor any of its affiliates will be responsible for any loss or damage that could result from interception and interpretation by any third parties of any information being made available to you through this website. The Company and its affiliates cannot and do not guarantee the accuracy, timeliness or completeness of the information being made available to you in the Draft Red Herring Prospectus beyond the date of the Draft Red Herring Prospectus. The information contained in the Draft Red Herring Prospectus may not be updated since its original publication date and may not reflect the latest updates. The Company and its affiliates will not be responsible for any loss to any person or entity caused by any shortcoming, defect or inaccuracy which may have inadvertently or otherwise crept into the website. Neither the Company, any of its affiliates nor their directors, officers and employees will be liable or have any responsibility of any kind for any loss or damage that you incur in the event of any failure or disruption of this website, or resulting from the act or omission of any other party involved in making this website or the data contained therein available to you, or from any other cause relating to your access to, inability to access, or use of the website or these materials.

If you are not permitted to view the materials on this website or are in any doubt as to whether you are permitted to view these materials, please exit this webpage.

To access this information, you must confirm by pressing on the button marked “I Confirm” that, at the time of access you are located and resident in India. If you cannot make this confirmation, you must press the button marked “I Do Not Confirm”.

The documentation contained in these pages is posted solely to comply with Indian legal and regulatory requirements. Making the information contained herein available in electronic format does not constitute an offer to sell, the solicitation of an offer to buy, or a recommendation to buy or sell securities of the Company in the United States or in any other jurisdiction, including without limitation, India.

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Legal Disclaimer – Important

PLEASE READ THIS NOTICE CAREFULLY. IT APPLIES TO ALL PERSONS WHO VIEW THIS WEBSITE. THESE MATERIALS ARE NOT DIRECTED AT OR INTENDED TO BE ACCESSED BY PERSONS LOCATED OUTSIDE INDIA. THESE MATERIALS ARE BEING MADE AVAILABLE ON THIS WEBSITE TO COMPLY WITH SECURITIES AND EXCHANGE BOARD OF INDIA (ISSUE OF CAPITAL AND DISCLOSURE REQUIREMENTS) REGULATIONS, 2018, AS AMENDED.

Investors should read the Draft Red Herring Prospectus and seek professional advice before taking any action.

IMPORTANT: You must read and agree with the terms and conditions of the following disclaimer before continuing.

The following disclaimer applies to the draft red herring prospectus of Molbio Diagnostics Limited (the “Company”) dated August 22, 2025 (the “Draft Red Herring Prospectus”) filed with the Securities and Exchange Board of India (“SEBI”) and hosted on this website in connection with the initial public offering of the equity shares (“Equity Shares”) of the Company (the “Offer”). You are advised to read the following notice carefully before accessing the Draft Red Herring Prospectus. In accessing the Draft Red Herring Prospectus, you agree to be bound by the following terms and conditions, including any modifications to them from time to time.

Access to the Draft Red Herring Prospectus does not constitute a recommendation by the Company, the members of the Syndicate (as defined in the Draft Red Herring Prospectus) or any of their respective affiliates or any other person to subscribe to the Equity Shares offered in the Offer.

The Draft Red Herring Prospectus is directed at, and is intended for distribution to, and use by, residents of India only. The information in this portion of our website, including the Draft Red Herring Prospectus, is not for publication or distribution, directly or indirectly, in or into the United States. The contents of the Draft Red Herring Prospectus is for your information only, and you acknowledge that access to the Draft Red Herring Prospectus is intended for use by you only and you agree not to forward the Draft Red Herring Prospectus on to any other person, internal or external to your company, in whole or in part, or otherwise provide access via e-mail or otherwise to any person. Any person into whose possession the DRHP comes is required to inform himself or herself about and to observe any such restrictions. BRLMs and/or its affiliates or their respective directors, officers and employees are not soliciting any action based on any of the information contained on this website, including the DRHP, and such information should not be construed as an offer, or invitation or offer to sell or the solicitation of any offer to buy or subscribe for or purchase any security. No part of the contents of the Draft Red Herring Prospectus shall be copied or duplicated in any form by any means or redistributed.

The Draft Red Herring Prospectus has been hosted on this website as prescribed under Regulation 26(1) of the Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) Regulations, 2018, as amended. Our Company has taken all necessary steps to ensure that the contents of the Draft Red Herring Prospectus as appearing on this website are identical to the Draft Red Herring Prospectus filed with the SEBI. You are reminded that documents transmitted in electronic form may be altered or changed during the process of transmission and consequently, neither the Company nor the BRLMs any of its affiliates accepts any liability or responsibility whatsoever in respect of alterations or changes which have taken place during the course of transmission of electronic data.

The Draft Red Herring Prospectus does not constitute an offer to sell or an invitation to subscribe to the securities offered in any jurisdiction to any person to whom it is unlawful to make an offer or invitation in such jurisdiction and is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where (a) distribution or use of such information would be contrary to law or regulation; or (b) the Company or any of its affiliates would by virtue of such distribution become subject to new or additional registration, licensing or other regulatory requirements. The Equity Shares offered in the Offer have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“U.S. Securities Act”) or any state securities laws in the United States, and unless so registered, may not be offered or sold within the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and in accordance with any applicable U.S. state securities laws. Accordingly, the Equity Shares are being offered and sold only outside the United States in ‘offshore transactions’ in compliance with Regulation S under the U.S. Securities Act and the applicable laws of the jurisdictions where such offers and sales are made.

Any person into whose possession the Draft Red Herring Prospectus comes is required to inform himself or herself about and to observe any such restrictions. Neither the Company, BRLMs nor any of its affiliates is soliciting any action based on the Draft Red Herring Prospectus, and it should not be construed as an offer to sell or the solicitation of an offer to buy any securities. Potential investors should not rely on the Draft Red Herring Prospectus for any investment decision.

Any decision on whether to invest in the equity shares described in the Draft Red Herring Prospectus may only be made after a red herring prospectus has been filed with the Registrar of Companies, Goa, Daman and Diu at Panaji and the SEBI and must be made solely on the basis of such red herring prospectus, as there may be material changes in the red herring prospectus compared to the Draft Red Herring Prospectus. Invitations to subscribe to or purchase the equity shares in the Offer will be made only pursuant to the red herring prospectus if the recipient is in India or the preliminary offering memorandum for the Offer, which comprises the red herring prospectus and the preliminary international wrap for the Offer, if the recipient is outside India. No person outside India is eligible to Bid for equity shares in the Offer unless that person has received the preliminary offering memorandum for the Offer, which shall contain the selling restrictions for the Offer outside India.

Any potential investor should note that investment in equity shares involves a high degree of risk and for details relating to such risk, please see the section titled “Risk Factors” of the red herring prospectus, when available.

Neither the Company, BRLMs, nor any of its affiliates will be responsible for any loss or damage that could result from interception and interpretation by any third parties of any information being made available to you through this website. The Company and its affiliates cannot and do not guarantee the accuracy, timeliness or completeness of the information being made available to you in the Draft Red Herring Prospectus beyond the date of the Draft Red Herring Prospectus. The information contained in the Draft Red Herring Prospectus may not be updated since its original publication date and may not reflect the latest updates. The Company and its affiliates will not be responsible for any loss to any person or entity caused by any shortcoming, defect or inaccuracy which may have inadvertently or otherwise crept into the website. Neither the Company, any of its affiliates nor their directors, officers and employees will be liable or have any responsibility of any kind for any loss or damage that you incur in the event of any failure or disruption of this website, or resulting from the act or omission of any other party involved in making this website or the data contained therein available to you, or from any other cause relating to your access to, inability to access, or use of the website or these materials.

If you are not permitted to view the materials on this website or are in any doubt as to whether you are permitted to view these materials, please exit this webpage.

To access this information, you must confirm by pressing on the button marked “I Confirm” that, at the time of access you are located and resident in India. If you cannot make this confirmation, you must press the button marked “I Do Not Confirm”.

The documentation contained in these pages is posted solely to comply with Indian legal and regulatory requirements. Making the information contained herein available in electronic format does not constitute an offer to sell, the solicitation of an offer to buy, or a recommendation to buy or sell securities of the Company in the United States or in any other jurisdiction, including without limitation, India.

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