Study-start-up/qc Specialist

2 weeks ago


Singapore Labcorp Full time

Purpose:
Study Start Up/QC Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU/QC Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient recruitment time.

Scope:
The SSU/QC Specialist is responsible for the start-up of clinical trial activities in their assigned country/countries to achieve greenlight for selected sites. Specialist also performs quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines, local requirements and Bayer QSDs.

Major Tasks:

- Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP and Bayer QSDs
- Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study
- Prepare and submit regulatory and IRB/IEC documentation as required per country requirements and Bayer QSDs during the course of the study
- Preparation, tracking, and distribution of site start up documentation including Investigator Site File
- Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
- Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards
- Monitor internal start up KPIs across studies and identify and communicate trends
- Support start up process improvement implementation
- In collaboration with CRA, maintain and ensure accuracy of site information in Vault
- Assist with audits/inspections of relevant start up activities and/or eTMF
- Attend and actively participate in team meetings by providing site greenlight projections and timelines
- Provide input on site activation strategy
- Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva

Qualifications:

- The incumbent should have a Bachelor’s degree (or equivalent) and minimum of 2 years of experience in clinical development including start up/ regulatory process experience
- Understanding of ICH-GCP essential documentation and familiarity with country specific clinical trial regulations
- Demonstrated ability to quality review documents and identify discrepancies/inconsistencies preferred
- Ability to embrace Veeva Clinical Vault system and associated functionality
- Strong written and verbal English communication skills
- Flexibility to adapt to changing business needs and priorities
- Demonstrated organization skills and attention to detail
- Strong service orientation
- Ability to work independently and manage multiple tasks and priorities

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.



  • Singapore Premier Research Full time

    Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices. We're looking for a talented and energetic...


  • Singapore Start-ups Full time

    This is a part-time hybrid role for a Creative Marketing Specialist at Start-ups in Singapore. The role involves tasks such as marketing, branding, social media marketing, communication, content creation, and social media management. Work from home is acceptable and can be based anywhere. Qualifications Marketing and Branding skills Social Media Marketing...

  • Qc Specialist

    2 weeks ago


    Singapore MiRXES Pte Ltd. Full time

    **QC Specialist** MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection...


  • Singapore Start-ups Full time

    This is a part-time hybrid role for a Creative Marketing Specialist at Start-ups in Singapore. The role involves tasks such as marketing, branding, social media marketing, communication, content creation, and social media management.Key ResponsibilitiesDevelop and implement effective marketing strategiesCreate engaging brand contentManage social media...


  • Singapore START UP DEVELOPMENT PTE. LTD. Full time

    Job OverviewSTART UP DEVELOPMENT PTE. LTD. is seeking a highly skilled Site Manager to join our team. In this role, you will be responsible for leading construction projects from start to finish, ensuring they are completed on time, within budget, and to the highest quality standards. Your expertise in reinforced concrete structure work, formwork and rebar,...


  • Singapore RECRUIT EXPRESS PTE LTD Full time

    Job Overview:We are seeking a highly skilled QC Laboratory Specialist to join our team at Recruit Express Pte Ltd.The successful candidate will have extensive experience in QC lab for biological production, including PCR, ELISA, CE-SDS, IcIEF, HPLC, and endotoxin testing.You will be responsible for developing and preparing a QC lab schedule for execution,...


  • Singapore This is an IT support group Full time

    At our IT support group, we are seeking a highly skilled QC Laboratory Specialist to join our team. This is a fixed term role with a duration of one year.The successful candidate will be responsible for ensuring the quality and accuracy of laboratory results in compliance with cGMP regulations and other international guidelines.Support new equipment...

  • QC Analyst

    7 days ago


    Singapore RECRUIT EXPRESS PTE LTD Full time

    Roles & ResponsibilitiesSalary : up to $6kDuration : 6 monthsWorking Days & Hours: 8am - 5pm, Monday to FridayLocation : Tuas (has bus pickups from Tuas Crescent MRT)Job Description: Experience in QC lab for biological production (PCR, ELISA, CE-SDS, IcIEF, HPLC, endotoxin, etc…) Develop and prepare a QC lab schedule for execution from the Manufacturing...

  • QC Analyst

    5 days ago


    Singapore RECRUIT EXPRESS PTE LTD Full time

    Roles & ResponsibilitiesSalary : up to $6kDuration : 6 monthsWorking Days & Hours: 8am - 5pm, Monday to FridayLocation : Tuas (has bus pickups from Tuas Crescent MRT)Job Description: Experience in QC lab for biological production (PCR, ELISA, CE-SDS, IcIEF, HPLC, endotoxin, etc…) Develop and prepare a QC lab schedule for execution from the Manufacturing...

  • Qc Manager

    2 weeks ago


    Singapore Bio-Rad Laboratories Full time

    Responsibilities: - Provide leadership and manage a team of Quality Specialist and Manufacturing Doc Specialist, and Technicians to perform QC activities and achieve pre-determined quality objectives set by the company - Establish and manages QC systems that will enhance and maintain products that meet quality specifications and standards for product...

  • Start-up Lead 2

    6 days ago


    Singapore ICON Full time

    **Study Start Up Specialist** **Singapore/Malaysia** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of...

  • QC Specialist

    7 days ago


    Singapore Lonza Biologics Porriño SLU Full time

    Lonza Biologics Porriño SLU is seeking a highly skilled QC Specialist to join our team. As a key member of our quality control department, you will be responsible for conducting analytical testing and providing results in accordance with cGMP regulations.The successful candidate will have a strong background in biochemistry and analytical techniques,...

  • Qc Technician

    2 weeks ago


    Singapore JointHire Singapore Pte Ltd Full time

    **Job Title**: QC Technician (5 Days/South West/AWS) **Industry**: Oil / Gas / Petroleum **Salary**: SGD 1800 - 2500 **Location**: South West, Singapore **About Company**: Founded in 1964, our client has progressed from a reputable distributor and manufacturer to become Asia's leading value-added integration specialist for Gas, Welding and Safety. With...


  • Singapore Start-ups Full time

    We are seeking a highly motivated and creative Part-time Marketing Professional to join our team. As a Creative Marketing Specialist, you will be responsible for developing and implementing effective marketing strategies, creating engaging brand content, and managing social media presence and online platforms.About the RoleThe role involves working on...

  • QA & Qc Executive

    2 weeks ago


    Singapore LEK LIM NONYA CAKE TRADING PTE. LTD. Full time

    **QA & QC Executive** We are looking for a QA & QC Executive to join our R&Ddepartment. You will gain broad experience and will be able to work in a fun fast-paced environment with a broad scope to develop. This position will report directly to the Food Technologist. This position will be instrumental in driving & ensuring excellence in production, QA...

  • Qc Specialist

    1 week ago


    Singapore amaris Full time

    Job description About the job Lead projects for method validation/verification/transfer to introduce new or remediated QC methods for testing existing and new products. Prepare and maintain method validation/verification/transfer Protocols, Reports, ensuring compliance with GMP and other standards. Ensure timely release of methods and equipment to support...

  • Qc Specialist

    1 week ago


    Singapore Amaris Consulting Full time

    **Who are we?**: **Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,500 people spread across 5 continents and more than 60...


  • Singapore ROBIN VILLAGE DEVELOPMENT PTE. LTD. Full time

    Job OverviewWe are looking for a highly skilled Quality Assurance and Compliance specialist to join our team at ROBIN VILLAGE DEVELOPMENT PTE. LTD.. As a Senior QA/QC Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality and safety.In this role, you will be responsible for managing the Quality Assurance...

  • QC Specialist

    1 week ago


    Singapore Project UARU Full time

    About the RoleWe are seeking a highly skilled QC Specialist to join our team. As a key member, you will be responsible for establishing and managing laboratory systems to achieve safe and stable commissioning and startup of the new plant. Your responsibilities will include:Conduct method development, validation, and upkeep SOPs, calibration, and analytical...


  • Singapore Funding Societies | Modalku Group Full time

    **Funding Societies | Modalku** is the largest SME digital financing platform in Southeast Asia, expanding into a leading SME neobank. We are licensed and registered in Singapore, Indonesia, Thailand, Malaysia, and operating in Vietnam, and backed by Sequoia India, Softbank Vision Fund and SMBC bank amongst many others. Funding Societies | Modalku provides...