Lilly
 

Career Opportunities

 
Job Posting Number
Job Description
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1

CLINICAL RESEARCH NURSE (CRN)

JOB DESCRIPTION:

  • Participates in the review of draft protocols.
  • Participates in recruitment activities via approved media, flyers and brochures. Identify and source for appropriate sites or avenues for subject recruitment.
  • Conducts and coordinates all general screening activities such as screening laboratory tests, clinical procedures and data documentation.
  • Ensures that recruitment/screening activities are in compliance with ICH-GCP (Good Clinical Practice), global and local SOP and guidelines, Singapore GCP and regulatory requirements.
  • Responsible for organising and managing the protocol set-up activities which involves the development of appropriate forms, labels, set-up medical equipment and arranging pre-study meetings.
  • Participates in clinical trial procedure/tasks as delegated by the Principal Investigator or designee.
  • Collects and verifies clinical trial data.
  • Demonstrates understanding and adheres to Good Clinical Practice, global and local policies and procedures and relevant regulatory requirements.

REQUIREMENTS:

  • Registered with Singapore Nursing Board.
  • Strong communication and customer relation skills.
  • Pleasant disposition, meticulous and systematic.
  • Able to multi-task and perform under pressure of strict timelines.
  • Computer literate.

We regret that only shortlisted candidates will be notified.

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2

LOCUM CLINICAL RESEARCH PHYSICIAN (3 – 6 months period)

Our mission is the conduct of research studies for novel drugs developed by Eli Lilly & Company. Our core area of interest and expertise is the conduct of First-in human, phase 1 and proof of concept studies, in healthy volunteers and in patients in the areas of neuroscience, diabetes and inflammatory disease. We also support appropriate academic studies in collaboration with local academic groups.

We are looking for a Locum Physician to act as a co-investigator in our unit. You must be a Singapore Registered Physician with minimum 3 years of medical practice (with some prior exposure to acute medicine) and competent in basic procedures such as drawing blood and placing cannulas. No clinical trial or research experience is needed, but we offer excellent clinical research training, experience of working for a MNC pharmaceutical company and deep engagement in design and implementation of clinical trials.

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3

CLINICAL PROJECT SPECIALIST

JOB DESCRIPTION:

Study Management

  • Manages study implementation from planning to closeout.
  • Liaises with the sponsor and site study team during the development phase of the protocol to ensure consistency and operational viability of a protocol.
  • Provides leadership in the review and development of study-related documents such as protocol, informed consent document, case report forms, source document worksheets, and CRU tools for study compliance (e.g. activity schedule and compliance checklist).
  • Manages process for study specific subject safety management.
  • Maintains oversight and performs checks on investigator trial master file.
  • Participates in the financial tracking of study activities and monitoring of study budget.
  • Responsible for the submission of all essential documents, amendments and reports to the ERB. Serves as the point of contact for all ERB related communication.
  • Leads in pre study meetings between sponsor and site study team.
  • Liaises with CRU operations team in logistics planning, study scheduling and training needs of site study team.
  • Coordinates with sponsor, and/or monitor on the timelines for Start-Up Meeting (SUM), site training, site initiation, site monitoring and close-out visits.
  • Serves as the focal point of study level communication between internal CRU team and external partners.
  • Tracks study timelines and provide study updates as required.
  • Identifies and communicates study status and issues that may impact on study timelines and deliverables. Escalates issues as appropriate.
  • Responsible for managing study related external vendors and collaborators (e.g. obtaining quotation for services, setting up contracts and agreements and conduct kick off meetings).

Study Implementation and Close-Out

  • Ensures timely reporting of all Serious Adverse Events (SAEs) to sponsor, local and global regulatory agencies as required.
  • Submits study status reports and updates to the ERB in a timely manner.
  • Facilitates and coordinates the resolution of any protocol issues with the site study team, sponsor and external vendors.
  • Coordinates and host all monitor site visits.
  • Coordinates and ensures prompt resolution of all data queries and monitoring issues.
  • Escalates unresolved quality or performance issues as necessary.
  • Coordinates delivery of study supplies (e.g. central laboratory kits, investigational products).
  • Coordinates archival of study documentation according to requirements.
  • Facilitates and collaborates with the CRU operations team in the planning, implementation and execution of studies with site study team.
  • Leads in preparation and sharing of study lessons learned.

REQUIREMENTS:

  • Diploma or Degree in Nursing, Science or health-related field (Health/Science/ Management).
  • At least 5 years of clinical research experience.
  • Experience in clinical trial study conduct processes.
  • Strong working knowledge of clinical pharmacology.
  • Excellent in organizational skills with a detailed outlook at things.
  • Strong leadership and interpersonal skills.
  • Highly flexible, motivated and proactive personality.
  • Proficient in Microsoft Office: Word, Excel, PowerPoint, etc.

To apply for the Clinical Project Specialist role, please send your resume to LCCPHR@lilly.com.

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