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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

LABORATORY SYSTEMS ASSOCIATE

JOB DESCRIPTION:

  • Establishes, develops, executes and completes installation records, qualification protocols and validation documentation.
  • Performs direct installation activities, such as creation, execution and completion of installation records.
  • Performs direct qualification activities, such as creation, execution and completion of qualification protocol (QMP, DQ/UR, IO, OQ, PQ and QSR).
  • Performs direct validation activities, such as creation, execution and completion of validation documentation (Validation plan, System Overview, Design Specifications, requirements, traceability matrix, Test Plan, Test cases, validation report, etc.) and supporting documents (i.e. Data Flow Diagrams).
  • Conducts validation or qualification tests of new or existing processes, equipment, or software, in accordance with internal protocols and where applicable, external standards.
  • Conducts routine review of validation or qualification documentation and processes to ensure compliance with internal or regulatory requirements.
  • Liaises with external parties on equipment and consumables.
  • Utilises various software applications, such as spreadsheet, relational databases, and electronic mail, to assemble or format data or test reports.
  • Performs entry and verification of data in laboratory systems and equipment.
  • Familiar with CSQ policies, procedures, SOPs and regulatory requirements for laboratory systems and equipment.
  • Tracks equipment issues/problems via an appropriate change control and problem management system.
  • Tracks equipment/system changes including but not limited to configuration change, access review or documentation update via an appropriate change and problem management system.

REQUIREMENTS:

  • Diploma or Degree in Life Sciences, Engineering, Information Systems or Computer Systems.
  • Preferable with biomedical and/or clinical research experience.
  • Good communication, time management and interpersonal skills.
  • Flexibility in work outlook.

We regret that only shortlisted candidates will be notified.

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3

CLINICAL PROJECT SPECIALIST

JOB DESCRIPTION:

  • 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, CRU tools for study compliance (e.g. activity schedule and compliance checklist).
  • Manages process for study specific subject safety management.
  • Maintains oversight 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.
  • 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.
  • 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.
  • Coordinates and host all monitor site visits. Coordinates and ensures prompt resolution of all data queries and monitoring issues.

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.
  • Highly flexible, motivated and proactive personality.

We regret that only shortlisted candidates will be notified.

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4

SCIENTIST (Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics)

JOB DESCRIPTION:

  • The design, execution and reporting of non-compartmental as well as population PK/PD modeling analyses and simulations for clinical trials
  • Utilizing in depth knowledge to develop best practices and new methodologies in modeling and simulation
  • Working with other members of your project team to provide timely deliverables to advance the development of both small and large molecules

REQUIREMENTS:

  • A good Honours Degree or Masters in Pharmacokinetics/Pharmacodynamics (PK/PD) or a related field such as Biological/Pharmaceutical Sciences, Pharmacology, Bioengineering and Computational Biology.
  • Previous industry (Pharma/Biotech) or academic experience in PK/PD analysis and modeling is preferred.
  • Working knowledge of relevant softwares such as WinNonlin, NONMEM, S-Plus, R or Matlab is highly desired.
  • Good understanding of clinical pharmacology (PK/PD and pharmacometrics) principles.
  • Fluency in the English language with excellent written and verbal communication skills.

We regret that only shortlisted candidates will be notified.

Apply Online