Summary
Overview
Work History
Education
Skills
Certification
Additional Info
About Me
Other Information
Timeline
Accomplishments
Work Availability
Work Preference
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Loshini R. Moorthy

Loshini R. Moorthy

Global Study Management Associate
Shah Alam

Summary

Dear Sir / Madam / HR Managers.

My Name is Loshini R. Moorthy. I have a bachelor’s degree in nursing from SEGi College, Kuala Lumpur with Qualified Annual Nursing Board Practice Certification (APC) and Certified in Good Clinical Practice (CGP). I am a cooperative and helpful team player with good interpersonal skills. I am very hard-working and ready to meet new challenges. I have the confidence and determination to succeed in my career. I have been exposed to highly sensitive issues and confidential information and therefore trustworthy. I am able to work independently with minimum supervision. To add more, I am an excellent team player, highly energetic, and perfection oriented. I have good administrative and people skills and will give my 100% commitment in anything I do. I'm applying for this position to enhance my knowledge and explore a new working environment. I hope you can consider my application. I would very much appreciate it if I was given the opportunity to work in your esteemed organization. Experienced with managing diverse tasks and supporting team initiatives. Utilizes organizational skills and attention to detail to enhance operational efficiency. Track record of effective collaboration and problem-solving in fast-paced settings.

Thank you,

Regards,

Loshini R. Moorthy

Overview

12
12
years of professional experience
2021
2021
years of post-secondary education
14
14
Certifications
3
3
Languages

Work History

Global Study Management Senior Associate

BeiGene Malaysia Sdn Bhd
04.2024 - 09.2024
  • The GSMA maintains the vendor contact list in collaboration with relevant CST stakeholders. The gCSM/gSMA regularly sends the contact list/s to the appropriate stakeholders to ensure all information remains current.
  • The gSMA works collaboratively with the Project Manager (PM) to support project management activities in accordance with local regulations and ICH GCP guidelines.
  • Ensure set up and ongoing maintenance of operational project plans, Timelines and study tracking tools and systems (such as CTMS, eTMF, and Financial Force), as required.
  • Take a lead role to provide support services to the team on regional studies while coordinating with the regional Clinical Support teams.
  • Prepare study templates and share them with the project team as needed such as ISF templates, Project Plans, and study tools.
  • Provide support to the PM on project finances as delegated such as SVT development, vendor invoices review and tracking, review of project level reports, and assist with project finance end-of-month activities (e.g. Revenue recognition).
  • Industry: - Research & Clinical Development
  • Specialization: - Project Management
  • Role: - GSMA
  • Position Level: - Senior
  • Mentored junior associates, fostering professional growth and helping them reach their full potential.
  • Completed daily logs for management review.
  • Drafted common document templates to reduce time spent creating documents from scratch.
  • Trained and supervised employees on office policies and procedures.
  • Managed data and correspondence to secure information across complex landscapes of organizational departments.

Project Specialist

Novotech
06.2022 - 04.2024
  • The Project Specialist (PS) works collaboratively with the Project Manager (PM) to support project management activities in accordance with local regulations, ICH GCP guidelines, Novotech/client SOPs, and the Project Agreement to deliver the project on time and to budget. PS also works in partnership with the PM to mitigate risk and ensure customer satisfaction related to assigned projects.
  • The Project Specialist should liaise with the Clinical teams and assist the PM with the delivery of the project from start-up through to the Closeout phase.
  • Project Specialist is expected to have a sound understanding of the drug development and clinical trial process, ICH GCP, and international and local regulatory requirements.
  • Assist the PMs to manage project deliverables, cost control, and risk management activities.
  • Ensure set up and ongoing maintenance of operational project plans, timelines, and study tracking tools and systems (such as CTMS, eTMF, and Financial Force), as required.
  • Take a lead role to provide support services to the team on regional studies while coordinating with the regional Clinical Support teams.
  • Prepare study templates and share them with the project team as needed such as ISF templates, Project Plans, and study tools.
  • Provide support to the PM on project finances as delegated such as SVT development, vendor invoices review and tracking, review of project level reports, and assist with project finance end-of-month activities (e.g., revenue recognition).
  • Liaise with client/alliance partner team members as delegated by the PM.
  • Assist the PM and Project Director (PD) with maintaining project CTMS compliance. Produce and review metrics reports, conduct gap and trend analysis, compliance monitoring, highlighting “red flags” and follow up for resolution.
  • Organize and support PM/LCRA to prepare project communications, agenda, and presentations comprising study data for study team meetings (internal and external) and prepare meeting minutes.
  • Assist the PM in vendor management activities to ensure delivery to contract as delegated.
  • Provide support to the PM in all start-up activities of the project such as tracking of submissions/approvals and preparation and review of activation forms and associated documentation.
  • Responsible for TMF Management on assigned projects including set up, management, and reviews plus support project audits as needed.
  • Ensure adherence to Company policies, SOPs, and procedures and be quality-minded in the performance of duties.
  • Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties and the performance of the study team, present a positive professional image of the company.
  • Industry: - Research & Clinical Development
  • Specialization: - Start-up and close-out trial phase
  • Role: - Project Specialist
  • Position Level: - Senior Project Specialist
  • Presented regular status updates to stakeholders, keeping them informed of progress toward established milestones.
  • Improved project efficiency by streamlining communication and collaboration among team members.
  • Coordinated cross-functional teams to achieve project objectives and meet deadlines.
  • Collaborated with stakeholders to define project scope, goals, and deliverables, ensuring alignment with business objectives.
  • Established clear lines of communication between all parties involved in projects, preventing misunderstandings or miscommunications from jeopardizing outcomes.
  • Maintained detailed documentation of project progress, facilitating smooth handovers and seamless transitions between phases.
  • Managed multiple projects simultaneously, ensuring timely completion and high-quality output.
  • Enhanced project visibility with creation of centralized project dashboard for real-time updates.
  • Facilitated training sessions for project management tools, enhancing team productivity.
  • Optimized resource allocation, resulting in cost savings and more efficient project execution.
  • Implemented quality control measures, significantly reducing errors and rework.
  • Managed project timelines to accommodate unexpected changes without compromising on deliverables.
  • Reduced project delivery times by coordinating efforts between teams, optimizing workflows for speed and efficiency.
  • Enhanced team collaboration by implementing weekly status meetings and open communication channels.
  • Reported regularly to managers on project budget, progress, and technical problems.
  • Tracked project and team member performance closely to quickly intervene in mistakes or delays.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.

Trial Capabilities Associate

Eli Lilly (Malaysia) Sdn. Bhd.
09.2021 - 06.2022
  • Manage and coordinate all the site and country-related clinical trial activities for the Australian and Indian Region.
  • Initiate investigator site activities, including collection and submission of regulatory documents, customization, and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent authority (CA) (where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully executed contracts, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.
  • Communicate with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
  • Communicate with Site Engagement and external party / clinical research organization to enable active collaboration during site activation, maintenance and close-out.
  • Manage investigator payments and any other financial transactions related to Trial Capabilities which include, but are not limited to, vendor creation and management, PO creation and maintenance, payment activities, country/site budget tracking, and payment-related issue resolution. Identify, communicate, and resolve issues.
  • Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
  • Leverage previous site/review board engagements to efficiently drive new work.
  • Escalate issues to align management and quality as appropriate.
  • Coordinate the management and delivery of clinical trial material to ensure support of site initiation.
  • Coordinate translation process for clinical trial documents and oversight of translation quality.
  • Populate internal systems to ensure the accuracy of trial/site performance.
  • Populate Trial Master Files and Libraries for future reference.
  • Provide feedback and shared learning for continuous improvement.
  • Anticipate and monitor dynamically changing priorities.
  • Understand and comply with procurements, legal and financial requirements, and procedures.
  • Understand, comply with, and reinforce local guidance regulations and guidance, Lilly Medical policies and procedures, and good clinical practices (GCP).
  • Industry: - Research & Clinical Development
  • Specialization: - Site Investigator & Negotiator
  • Role: - Trial Capabilities Associate
  • Position Level: - Site Manager
  • Established strong relationships with key stakeholders, facilitating effective communication across departments and teams.
  • Managed a diverse team of professionals, fostering an inclusive work environment that encouraged collaboration and innovation.
  • Improved project delivery times with implementation of streamlined communication strategy.

Study Coordinator

Sunway Medical Centre Sdn. Bhd.
05.2018 - 08.2021
  • Report to the head of CRC & Admin Manager.
  • Update Investigator database from hospital & Satellites, Investigator GCP list and feasibility log.
  • Manage & coordinate feasibility study received from Feasibility Team, meeting new & potential Investigators interested in feasibility questionnaires within timelines.
  • Monthly ISR report to ARM on ongoing clinical trials, new trials, and upcoming trials. - Informed and update ARM on any new potentials awarded ISR to site, preselection visits Meeting etc.
  • Assist in the preparing site for CRA’s site selection and site initiation visit meeting.
  • Guide Investigators on the payment process of study budget - To observe studies, perform in accordance with the protocol, SOP and applicable guidelines.
  • Identify and assist in recruitment of study subjects.
  • To ensure the good data quality and timely completion of Case Report Form (CRF) or e-CRF.
  • Handling and preparing specimen for vendor’s collection.
  • Collection of Investigational Product (IP) and manage the storage and record.
  • Manage orders, dispensing, maintaining and accountability of investigational product and clinical supplies.
  • Ensure PI identifies, report, complete and submit AE/SAE forms to Appropriate authorities.
  • Act as liaison between investigators and CRAs, preparing site for monitoring, audit and inspection and subsequent implementation of recommended corrective actions as appropriate.
  • Complete, review and store CRFs and source documents in timely manner.
  • Assist Investigator during subject’s clinic follow up.
  • Schedule and manage subject visits.
  • Coordinate with Sponsor in project closeout activities including disposal of IP, collecting materials for archiving and any other related activities.
  • Assist with preparing site documents for COV & archiving.
  • Industry: - Healthcare / Medical
  • Specialization: - Clinical Trial Support & Assistant
  • Role: - Senior Study Coordinator
  • Position Level: - Senior Executive (Level 4)
  • Streamlined communication between participants and research team, fostering effective collaboration and data collection.
  • Contributed to a positive work environment by fostering open communication, teamwork, and professional development opportunities for staff members.
  • Expedited study start-up timelines by efficiently coordinating site initiation visits, trainings, and equipment setup.
  • Improved data accuracy by implementing rigorous quality control measures during data collection and entry processes.
  • Provided comprehensive training to new staff members, ensuring seamless integration into existing workflows while maintaining high-quality work standards.
  • Maintained up-to-date knowledge of industry best practices, regulations, and advancements in clinical research coordination methodologies.
  • Enhanced patient satisfaction by efficiently coordinating and managing study schedules.
  • Facilitated timely enrollment of participants through targeted recruitment strategies.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.

Study Coordinator Level II

Clinical Research Malaysia
11.2014 - 04.2018
  • Report to the head of CRC & Admin Manager
  • Update Investigator database from hospital & Satellites, Investigator GCP list and feasibility log.
  • Manage & coordinate feasibility study received from the Feasibility Team, meeting new & potential Investigators interested in the feasibility questionnaires within timelines.
  • Monthly ISR report to ARM on ongoing clinical trials, new trials and upcoming trials.
  • Informed and updated ARM on any new potentials awarded ISR to site, pre selection visit Meetings etc.
  • Assist in the preparing site for CRA’s site selection and site initiation visit meeting.
  • Guide Investigators on the payment process of study budget
  • To observe studies, perform in accordance to the protocol, SOP and applicable guidelines.
  • Identify and assist in recruitment of study subjects.
  • To ensure the good data quality and timely completion of Case Report Form (CRF) or e-CRF.
  • Handling and preparing specimen for vendor’s collection.
  • Collection of Investigational Product (IP) and manage the storage and record - Manage orders, dispensing, maintaining and accountability of investigational product and clinical supplies.
  • Ensure PI identifies, report, complete and submit AE/SAE forms to appropriate authorities.
  • Act as liaison between investigators and CRAs, preparing site for monitoring, audit and inspection and subsequent implementation of recommended corrective actions as appropriate.
  • Complete, review and store CRFs and source documents in timely manner.
  • Assist Investigator during subject’s clinic follow up.
  • Schedule and manage subject visits.
  • Coordinate with Sponsor in project closeout activities including disposal of IP, collecting materials for archiving and any other related activities.
  • Assist with preparing site documents for COV & archiving.
  • Site: - Hospital Ampang, Ampang Jaya, Selangor.
  • Industry: - Healthcare / Medical
  • Specialization: - Medical Support & Assistant
  • Role: - Study Coordinator Level II
  • Position Level: - Senior Executive

Clinical Research Associate I

Veras Research Sdn. Bhd.
01.2014 - 10.2014
  • Responsible for performing all monitoring aspects of clinical trials and assist to set up, review and maintain project files to ensure compliance as stated in ICH E6 GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements.
  • Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring and close-out visits in accordance with sponsor’s and / or company’s standard operating procedures (SOPs) and study requirements with the highest standards.
  • Planning, develop, compile and / or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents.
  • Develop, compile and / or submit dossiers include initial / amendment / interim report / safety reporting to regulatory and / or ethics committee for review and follow up until approval, as required.
  • Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required.
  • Manage / support project(s) in the capacity of lead CRA role and / or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company.
  • Support / Assist in Site and CRO audit or inspection as required
  • Support business development activities (e.g., search new project related information. As for senior CRA, project bidding also) as required
  • Proactively identify and facilitate resolution of complex study problems and issues.
  • Actively work towards achieving good personal relationships with the project Team members
  • Assist in the development and implementation of recruitment strategies to increase patient randomization into the trial (e.g., investigator and research nurse meetings, update newsletters, advertising, and letters to GPs).
  • Work with the CRA to update the Patient Tracking Database – which includes details of patient recruitment into clinical trials, each individual’s progress through the trial, payments due to investigators, total paid to site, adverse events and other relevant patient related information.
  • Maintain a database that records details of clinical trial shipments, and in collaboration with the CRA ensure that there are adequate supplies of clinical trial material to meet project needs. Plan, order and distribute non-drug clinical trial supplies e.g., clinical report forms, diary cards.
  • Responsible for logging in received CRFs and transferring data from the CRFs into the database.
  • Assist the CRA during the preparation for the investigator study initiation meeting.
  • Industry: - Research & Clinical Development
  • Specialization: - Junior Support & Assistant
  • Role: - Clinical Research Associate I
  • Position Level: - Junior Executive

Staff Nurse

Sime Darby Medical Centre
03.2013 - 12.2013
  • The main front liner who renders nursing care to patients within Sime Darby Medical Centre.
  • Responsible of providing nursing leadership and is accountable for the coordination of clinical activities for the unit.
  • Makes professional judgement and decisions about nursing care.
  • Carries out specialist’s order in accordance to established standards of nursing practices, policies and procedures, charts and documents all accurately.
  • Ability to identify safety hazards and immediately initiate corrective actions.
  • Industry: - Health & Medical Centre
  • Specialization: - Nurse
  • Role: - Nurse
  • Position Level: - Entry Level / Fresh
  • Administered medications via oral, IV, and intramuscular injections and monitored responses.
  • Performed various nursing interventions such as wound dressing, vital sign monitoring, and specimen collection.
  • Monitored patients' conditions and reported changes in physical presentation, appearance, and behavior to discuss treatment with physicians.

Education

Bachelor's Degree - BSc Hons Professional Practice in Nursing

SEGi College Kuala Lumpur

Diploma - Diploma in Nursing

Sime Darby Nursing and Health & Science College

Skills

Advanced: - Ms Word, Good Clinical Practice Certified - (GCP), Qualified Nursing Board Certification (APC)

Certification

Certification of Participating in a Clinical Trial Hands–On Training - A Workshop Organised by Clinical Research Malaysia / 5th, 6th & 7th Nov 2014.

Additional Info

Preferred Work Location: - Perak, Selangor, Kuala Lumpur, Singapore & Oversea

About Me

  • Gender: - Female
  • Age: - 32 Years Old
  • Correspondence Address: - No. 2 -1 - 20, Block 2 Antilla 2, Jalan Anggerik Malaxis 31/171, Kota Kemuning, Seksyen 31, 40460 Shah Alam Selangor.
  • Nationality: - Malaysian
  • Marital Status: - Married

Other Information

  • Trainings & Workshop (I have attended):
  • 1. Certification of Participating in a Clinical Trial Hands–On Training - A Workshop Organised by Clinical Research Malaysia / 5th, 6th & 7th Nov 2014.
  • 2. Certification of Participating in a Pathfinder Forum in Rome, Italy - A Workshop Organised by Nova Nordisk A/S / 14th & 15th March 2015.
  • 3. Certification of Completion of Clinical Trial Management - A Workshop Organised by Clinical Research Malaysia / 26th & 27th April 2015.
  • 4. Certification of Completion of Creating a Clinical Trial Budget - A Workshop Organised by Clinical Research Malaysia / 27th July 2015.
  • 5. Certification of Participating in a “Franklin Covey” - Leadership Training - A Workshop Organised by Clinical Research Malaysia / 1st, 2nd & 3rd Sep 2015.
  • 6. Certification of Completion of Protocol Deviation Workshop for Study Coordinators - A Workshop Organised by Clinical Research Malaysia / 31st Mar 2016.
  • 7. Certification of Participating in a Haemophilia Study Result Forum in Paris, France - A Workshop Organised by Nova Nordisk A/S / 12th & 13th September 2016.
  • 8. Certification of Achievement in Microsoft Excel in 2013 ‘Intermediate’ - A Workshop Organised by InfoTrek on behalf of CRM / 30th September 2016.
  • 9. Certification of Achievement in Completing the SOP Training Level I - A Workshop Organised by Clinical Research Malaysia / 31st July & 01st August 2016.
  • 10. Certification of Achievement in Completing the SOP Training Level II - A Workshop Organised by Clinical Research Malaysia / 11th & 12th January 2017.
  • 11. Certification of Appreciation for being a Facilitator during ‘Protocol Deviation (PD) Workshop - A Workshop Organised by Clinical Research Malaysia / 20th May 2017.
  • 12. Certification of Participating in a ‘Basic Biostatic’ – Training - A Workshop Organised by Clinical Research Centre (CRC) Network, Ministry of Health Malaysia in Hospital Ampang / 13th & 14th September 2017.
  • 13. Certification of Participation in 11th National Conference for Clinical Research Forum - A Workshop Organised by Clinical Research Centre (CRC) Network, Ministry of Health Malaysia / 27th, 28th & 29th Sept 2017.
  • 14. Certification of Participation in National Hepatitis Symposium 2018 Conference - A Workshop Organised by Gastroenterology & Haematology Unit of Hospital Ampang and University Science Islam Malaysia / 1st & 2nd March 2018

Timeline

Global Study Management Senior Associate

BeiGene Malaysia Sdn Bhd
04.2024 - 09.2024

Project Specialist

Novotech
06.2022 - 04.2024

Trial Capabilities Associate

Eli Lilly (Malaysia) Sdn. Bhd.
09.2021 - 06.2022

Study Coordinator

Sunway Medical Centre Sdn. Bhd.
05.2018 - 08.2021

Study Coordinator Level II

Clinical Research Malaysia
11.2014 - 04.2018

Clinical Research Associate I

Veras Research Sdn. Bhd.
01.2014 - 10.2014

Staff Nurse

Sime Darby Medical Centre
03.2013 - 12.2013

Diploma - Diploma in Nursing

Sime Darby Nursing and Health & Science College

Bachelor's Degree - BSc Hons Professional Practice in Nursing

SEGi College Kuala Lumpur

Accomplishments

  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Collaborated with team of Project Specialist in the development of customised Veeva Study Reports

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference

Work Type

Full TimeContract Work

Work Location

On-SiteRemoteHybrid

Important To Me

Work-life balanceCareer advancementPersonal development programsCompany Culture

Languages

English
Advanced (C1)
Malay
Advanced (C1)
Tamil
Elementary (A2)

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Loshini R. MoorthyGlobal Study Management Associate