Study Start-Up Coordinator

23 hours ago

Singapore beBeeRegulatory Full time $80,000 - $120,000
Clinical Trial Specialist Job DescriptionJob Overview:We are seeking a Clinical Trial Specialist to join our team. The successful candidate will be responsible for managing clinical trial activities, including study start-up and ongoing study document management.Key Responsibilities:
  • Manage activities related to study start-up and ongoing study document management.
  • Serve as the point of contact for local study teams and external stakeholders.
  • Independently handle multiple country, study, and site level deliverables during start-up and maintenance, engaging with both internal and external business partners and vendors as needed.
  • Strategize and plan start-up activities to ensure successful recruitment and delivery.
  • Facilitate the preparation of Investigator Sites for clinical trials by reviewing and approving essential clinical trial and regulatory documents.
  • Assist local regulatory activities by preparing and submitting documents for Health Authorities, including follow-up until approval, and for Ethics Committees, including follow-up until approval.
  • Collaborate with various internal roles in country feasibility and site selection.
  • Work closely with internal study teams, external site staff, and country ethics committees/IRB to align tasks and priorities with defined study timelines.
  • Manage the preparation and approval of country Informed Consent Form (ICF) and ICF template, Site ICFs, Clinical Trial Package (CTP) documentation, and national registries update.
  • Ensure the electronic Trial Master File (eTMF) contains the relevant CTP regulatory documents for site activation and ongoing study management.
  • Review and translate drug/IMP labels when applicable.
  • Stay updated on country regulatory requirements and evolving regulations in collaboration with Regulatory and legal teams.
  • Provide support for Health Authority inspection, pre-inspection activities, audit preparation, and Corrective Action/Preventative Action preparation for local issues.
Required Skills and Qualifications:
  • Bachelor's degree in Life Sciences or equivalent.
  • 3+ years of industry experience, including handling trial startup activities, coordinating trial activities, and submitting to Health Authorities/Ethics Committees.
  • Profound understanding of GCP, ICH Guidelines, and country-specific regulatory environments.
  • Thorough knowledge of clinical research processes, regulations, and methodology.
  • Demonstrated organizational, planning, and decision-making skills.
  • Experience in leading or participating in cross-functional teams, task forces, or global initiatives.
  • Strong organization, time management, and prioritization skills with the ability to manage multiple tasks effectively.
  • Ability for critical thinking and risk analysis.
Benefits:
  • Opportunities for career growth and development.
  • A collaborative and dynamic work environment.
  • A competitive salary and benefits package.
  • Access to cutting-edge technology and resources.
  • Professional training and development opportunities.
How to Apply:

If you are a motivated and detail-oriented individual with a passion for clinical trials, please submit your application. We look forward to hearing from you.

  • Start-up Coordinator

    3 days ago

    Singapore beBeeStartup Full time $80,000 - $150,000

    Job Title: Start-up CoordinatorAs a Start-up Coordinator, you will oversee the initiation and activation of construction and installation activities to ensure they are completed efficiently. This includes planning and deploying teams to meet start-up schedules, developing protocols for systematic commissioning, and coordinating with Original Equipment...

  • CTA/ Study Start up Specialist

    1 day ago

    Singapore Syneos Health Full time

    CTA/ Study Start up Specialist (Mumbai Location)Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We specialize in translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. Our Clinical Development model revolves...

  • Study Start Up Submissions Coordinator

    2 weeks ago

    Singapore Medpace, Inc. Full time

    Job Summary: We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in the Singapore office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your...

  • Regulatory & Start-up Specialist

    3 days ago

    Singapore IQVIA Full time

    **Responsibilities**: - Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). - Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM...

  • Site Start-up Associate Ii

    5 days ago

    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...

  • Regulatory and Start Up Specialist

    6 days ago

    Singapore Precision for Medicine Full time

    Precision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition...

  • Start-up, Project Manager

    1 week ago

    Singapore Labcorp Full time

    The Local Start-Up Project Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments...

  • Start-up Lead 2

    2 weeks 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...

  • Regional Study Coordinator

    2 weeks ago

    Singapore Labcorp Full time

    In this role you will be responsible for managing clinical projects to ensure the successful delivery of all lab services, including kits shipment, sample testing and sample management of a clinical study for the Asia region - Act as regional liaison between Labcorp Central Lab Services (CLS) Global Study Manager and various CLS departments involved in the...

  • Regional Study Coordinator

    2 days ago

    Singapore LABCORP DEVELOPMENT (ASIA) PTE. LTD. Full time

    Join our talent pool for future needs Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities? If you are looking for a company where you can personally advance healthcare and make a difference in peoples' lives with your bold ideas...