Study-start-up/qc Specialist

7 days 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.

  • Senior Global Start Up Specialist

    2 weeks ago

    Singapore beBeeClinicalResearch Full time $80,000 - $120,000

    Regulatory Submissions ManagerThe role of Regulatory Submissions Manager is to oversee the entire start-up process for clinical research studies. This involves efficiently managing all aspects of global start-up, performing quality checks on submission documents and site essential documents, preparing and approving informed consent forms, reviewing pertinent...

  • Qc Manager

    2 weeks ago

    West Singapore SUNWARD PHARMACEUTICAL PRIVATE LIMITED Full time

    **Location** - Singapore, West**Job Type** - Permanent**Salary** - $3,000 - $6,000 Per Month**Date Posted** - 13 hours agoAdditional Details **Job ID** - 138540**Job Views** - 1Roles & Responsibilities Responsible on daily quality control activities and ensure all activities are according to SOP and GMP requirements. - Laboratory management - Ensure QC...

  • QA & Qc Executive

    1 week 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 MIRXES PTE. LTD. Full time

    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 and provide...

  • QC Specialist I

    2 weeks ago

    Singapore Novartis Singapore Full time

    Summary Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP's and local/international regulations. About The Role Key Responsibilities: OOx/Deviation handling . CAPA definition -KPI trending -Ensure all...

  • QC Specialist I

    2 weeks ago

    Singapore Novartis Farmacéutica Full time

    Choose LocationChoose Location# QC Specialist I (Microbiology)REQ- Sep 11, 2025Singapore### SummaryEstablish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP's and local/international regulations.### About the...

  • QC Specialist I

    2 weeks ago

    Singapore Novartis Farmacéutica Full time

    Choose LocationChoose Location# QC Specialist I (Microbiology)REQ- Sep 11, 2025Singapore### SummaryEstablish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP's and local/international regulations.### About the...

  • QC Specialist I

    1 week ago

    Singapore Novartis Singapore Full time

    Summary Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP’s and local/international regulations. About The Role Key Responsibilities: OOx/Deviation handling . CAPA definition -KPI trending -Ensure all...

  • QC Specialist/ Senior QC Specialist

    16 hours ago

    Singapore F. Hoffmann-La Roche AG Full time

    QC Specialist/ Senior QC Specialist page is loaded## QC Specialist/ Senior QC Specialistlocations: Singaporetime type: Full timeposted on: Posted Todayjob requisition id: At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued,...

  • Qc Technician

    1 week ago

    Singapore CT Solutions (Pte. Ltd.) Full time

    Position: QC Technician - Well Established US Based Manufacturing MNC - Working hours: Monday - Friday (8.00am to 5.15pm) - Salary (commensurate with experience): up to $2,000 - Working Location: Tuas - Company transport provided - Duration: Permanent - Industry: Manufacturing **Main Responsibilities**: - Involved in QA/QC incoming and outgoing...