Clinical Trial Manager

ICON plc
ICON plc
( Other )
asiaremotejobs.com  Remote (Asia | APAC Time Zone Permitted)

Job Type : Full-Time
Experience : 3 to 5 years
Education : Bachelor Degree

Job Detail
  • Attractive Compensation
  • Flexible Work Arrangement
  • Opportunity to grow with Global Pharma Company

KEY RESPONSIBILITIES:

Study Management Team Leader

  • Lead the Study Management Team (SMT), drive issue resolutions, and provide updates to all trial team members on the deliverable status
  • Ensure required reports are generated and available for real time tracking of trial status
  • Manage timely and accurate documentation, communicate trial progress and issue escalation

Site Selection, Enrollment, Trial Progress

  • Coordinate the data collection and prepare/drive the site selection decision process
  • Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level. Ensure the availability of robust recruitment/contingency plans for each region
  • Ensure timely and accurate documentation and communication of study progress and issue escalation.

Financial planning and tracking

  • Ensure continuous forecasting (CF), Quarter Close review and affiliate finances relative to the trial are completed in conjunction with the countries according to due dates/actions (in-house trials)
  • Ensure accurate budget management for assigned trials, in alignment with the Global Trial Leader, including the budget updates in line with scope & follow up on budget variances. This includes ensuring vendors and affiliate budgets are tracked according to plan. Updates are made to proactively account for scope changes

Document development and update

  • Create and update trial-specific documents such as, but not limited to, Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product (IMP) related documentation, Blinding Plan, country and site feasibility related documents
  • Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan

Cross functional Trial Management

  • Act as the primary contact person for the local teams within GCDO. Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit
  • Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge

REQUIREMENTS:

  • BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
  • Minimum of 8 years clinical trial management experience in the pharmaceutical industry or CRO.
  • Requires clinical research operational knowledge, strong project planning/management expertise and effective communication skills.
  • Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
  • Proven track record in successfully managing trials and leading country teams from start-up to database lock. Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.
  • Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.
  • Ability to independently manage multiple stakeholders. Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
  • Effective verbal and written communication skills leading to successful team collaboration.
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