Clinical Project Specialist - 1 Yr Contract

LILLY CENTRE FOR CLINICAL PHARMACOLOGY PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Lilly Centre for Clinical Pharmacology PTE. LTD. is seeking a Study Manager to oversee clinical trial execution within the Clinical Research Unit in Singapore. The role ensures SOP/GCP compliance and acts as the primary liaison with sponsors, monitors, and ERB.

The ideal candidate brings a Diploma or Degree in Nursing, Science or health-related field with at least 5 years in clinical research, strong GCP knowledge, and proven leadership to drive study integrity and timelines.

Qualifications

• Diploma or Degree in Nursing, Science or health-related field.
• At least 5 years of clinical research experience.
• Excellent GCP knowledge and study conduct experience.

Responsibilities

• Manage study implementation from planning to closeout.
• Liaise with sponsor and site team during protocol development for viability.
• Lead review of study documents (protocol, consent, CRU tools).
• Coordinate risk assessments and mitigation plans for studies.
• Oversee maintenance of investigator trial master files and budgets.
• Serve as liaison between CRU, sponsor, ERB and monitors.
• Coordinate training, initiation, monitoring and close-out visits.
• Escalate quality or performance issues and coordinate study deliveries.

Skills

GCP knowledge

Project management

Leadership

Communication

Organizational skills

Proactive

MS Office

Education

Diploma or Degree in Nursing, Science or health-related field

Tools

Microsoft Office

Job description

PURPOSE OF THE JOB

Responsible for the effective management and implementation of clinical trials in the Clinical Research Unit (CRU) in compliance will all relevant Standard Operating Procedures (SOPs), Good Clinical Practice Guidelines (GCP) and relevant regulatory requirements.

Serves as the primary liaison between CRU study team and Sponsor on operational matters, Sponsor representatives (e.g. monitors, vendors) and Ethics/Institutional Review Board (ERB).

CORE JOB TASK

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).
• Coordinates with CRU team in the discussion of study risk assessment and oversees implementation of relevant mitigation plans.
• Manages process for study specific subject safety management.
• Responsible for maintenance and completeness of investigator trial master files.
• Assists with the financial tracking of study activities and monitoring of study budget.
• Serves as the primary liaison between CRU study team and external Sponsors, ERB and monitors.
• Coordinates with sponsor, and/or monitor on the timelines for site training, site initiation, site monitoring and close-out visits.
• Leads site study meetings and coordinates between sponsor and site study team on study requirements.
• Liaises with CRU operations team on logistics planning, study scheduling and training needs of site study team.
• Responsible for managing study related external vendors and collaborators (e.g. conduct kick off meetings), or overseeing similar external engagements lead by study team members as appropriate to each function.
• Tracks study timelines and provide study updates to Sponsor and CRU teams.
• Identifies and communicates study status and issues that may impact on study timelines and deliverables. Escalates issues as appropriate.

Study Implementation and Close-Out

• Ensures timely submission of all IRB required study documents, for example, protocol, protocol amendments, informed consent forms, questionnaires, etc.
• Coordinates with the PI to ensure timely submission of required reports to IRB: for examples, study status reports, IRB renewal, UPIRTSO, deviations, etc.
• Ensures timely reporting of Serious Adverse Events (SAEs) and Suspected Offences and Contraventions (SOC) to internal stakeholders (e.g. study PI, Principal Personal In Charge) and external stakeholders (e.g. sponsor, local and global regulatory agencies) as required.
• Facilitates and coordinates the resolution of any protocol issues with the site study team, sponsor and external stakeholders.
• 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.
• Works with other functions in the CRU to coordinate 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.

Others

• Reviews, updates and implements local standard operation procedures and work instructions as appropriate.
• Participates in projects or work improvement processes as required.
• Supports audit and inspection visits by Lilly and external agencies.

Required Qualifications and Experience

• Diploma or Degree in Nursing, Science or health-related field (Health/Science/ Management).
• At least 5 years of clinical research experience.

Required Skills

• Excellent GCP knowledge with experience in clinical trial study conduct processes.
• Excellent organizational and project management skills.
• Excellent verbal and written communication skills.
• Strong leadership and interpersonal skills.
• Highly flexible, motivated and proactive personality.
• Proficient in Microsoft Office: Word, Excel, PowerPoint, etc.

Other Information

• Familiar with operations of a CRU/phase 1 unit organization.
• Willing to travel when required.