Nandhakumar Muruganantham Email & Phone Number

Singapore

• Responsible for managing end to end large scale global and regional clinical trials which involves leading an internal project team and external stakeholders to ensure right first-time project execution.• Successfully conducted a mobile App pilot clinical trial for one of the major bio-pharmaceutical clients which paved the way for transformational clinical trial management of the future.• Analyze & resolve the real time issues by providing valuable suggestions to the sponsor and medical monitor with factual study data. • Leveraging my knowledge of medical device regulations and standards to ensure compliance and quality of the clinical trial data and procedures aligning with the clinical study requirement. • Assessing Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.• Lead inventory management process for testing kits by meticulous planning and coordination with the different logistics counterparts across pan-Asia Pacific region.• Collaborating with cross functional global & regional operations teams to foresee and trouble shoot the root cause of any potential issue and manage issue resolution.• Manage comprehensive review of study documentations and trial database to prevent any non-compliance on the agreed scope of work.• Subject matter expert for LIMS database, conduct verification checks and run various reports to analyze the study trial data points and coordinate with the clinical operations team to streamline the healthcare procedures.• Core team lead for successful delivery of the new dashboard development to manage clinical trials.• Manage various business dashboard validations by writing test cases, performing dry runs and User Acceptance Test prior to the production release.

Singapore

• Managing the clinical studies (Phase I to IV) as per organizational standards, sponsor & protocol specific requirements without any project related issues and problems.• Foreseeing and developing solutions for any potential issues and proactively resolving to mitigate the study related risks.• Ensure outputs are delivered in line with organizational standards, protocol specific requirements and client expectations and providing regular project status reports to the CRA, Sponsor and/or the company as applicable.• Overseeing and managing the timely closure of all departmental escalated queries at all stages of the study and work closely with the internal, cross functional & external team members to support the study.• Delivered overall 42 projects at a time (21 each of global & regional) in one financial year which was best in class for the business and this led to consider me for promotion to Senior Project Coordinator.• Received recognition and appreciation for excellent project delivery by a key account client, Bristol-Myers Squibb (leading global bio pharmaceutical company). Also received employee recognition Silver Award for the same from Q Squared Solutions Pte Ltd.

Singapore

• Configured and maintained the client database for clinical trials in the Laboratory Information Management Systems (LIMS).• Successfully worked on multiple portals to maintain study database in order to comply with client protocol and expectations.• Configure kit design, label specifications, requisition printing, sample entry, analysis and onward storage in the system for different types of studies such as safety, anatomical pathology, companion diagnostics, alien import and long-term storage for specimen management studies etc.• Responsible for managing the Lab Vantage platform to track the sample shipment and drive data management team to map, integrate & import the data within the instruments and LIMS systems.• With the solid experience in the downstream process of the Laboratory Information Management Systems (LIMS), later moved to the project management side of the laboratory operations and services.

Singapore

• Successfully conducted basic and applied research on novel Anti-Microbial peptides for emerging wide range of Eye related fungal diseases and Investigated the impact of intrinsic properties of different antimicrobial peptides against wide range of microorganisms on both in vitro and in vivo studies.• Designed and optimized assays to study the effectiveness of the antimicrobial peptides on microorganisms such as bacteria (Staphylococcus aureus, MRSA and Pseudomonas); Yeast (Candida sp.) and Fungus (Fusarium and Aspergillus sp.). Cared for and studied rodents for different in vivo testing of antimicrobial peptides.• Interpreted research findings and summarized preclinical data into reports which helped our research group to get the Sing Health grant of SGD 150,000 and got Cooperative Basic Research Grant 2013 worth of SGD 1 Million.• My research data has been published as 5 scientific papers in the leading journals.

Chennai, India

• In the start-up company, took leadership responsibility for both technical and marketing activities.• Provided technical Resource for Undergraduate and Graduate students and trained them in the field of Microbiology, Molecular Biology, Immunology, Plant Tissue Culture etc.• Led extensive market research and collaboration activities with top universities in the city to promote the lab through giving lectures and presentations to students on specific scientific topics. • Drove business development activities like presenting business plan to the Director of Micro- Small-Medium Enterprises, for acquiring Government of India’s accreditation and funding.• My article about the company was published in the supplement of leading News Daily “The Hindu - Educational Plus” in both the city and the state editions. This publication helped improve our business visibility and attracted a number of offers.

Oxford, United Kingdom

MSc Biotechnology - Graduate ResearchBaculovirus DNA genomes are normally infectious for Trichoplusia ni insect cell lines after introduction via liposome-mediated transfection. There are two main reasons that why it is producing infectious particles are either the host cell itself would have got that DNA by origin or it would have been transformed into the cell line from the past viral infection. To thrive deep further, we are going to delete some more genes by bacterial recombination system in the viral genome to study its effect in the insect cell line.• Baculovirus are 100% safe to express recombinant proteins in humans• It’s easy to manipulate and highly efficient than Pox, Adeno or Retro virus• Moreover, it can also be used for vaccine production in gene therapy• Done a complete study of genome sequencing of an insect cell line infected with baculovirus.• Successfully deleted lef1 and lef2 genes which are essential for baculovirus replication.• Performed liposome-mediated transfection for viral infection.• Viral replication and gene knock out experiments were confirmed by doing PCR, QPCR and Electrophoresis techniques.

Master Of Science (Msc), Biotechnology, Merit

Bachelor Of Technology (B.Tech.), Biotechnology, 8.804 Cgpa