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Clinical Trial Manager

13 hours, 32 minutes ago
Singapore, Australia
Senior
Project Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 4

Description

  • Serve as the primary clinical point of contact for the client and maintain effective study communications.
  • Collaborate with the Project Manager on monthly invoicing, budget variance management and project-specific resourcing issues.
  • Develop study-related clinical documents and training materials (clinical plans, ICF templates, CRF completion guidelines, trackers, PSV/SIV slides, manuals).
  • Generate site lists, drive site feasibility, identify enrollment risks, and develop country-level recruitment and retention strategies.
  • Lead internal clinical team meetings, set expectations for CRAs/CTAs, address CRA and site questions, and maintain an FAQ log.
  • Oversee site start-up, enrollment, maintenance and close-out activities, and support planning/conduct of investigator meetings.
  • Manage regulatory interactions: oversee submissions/approvals to Competent Authorities and IRB/ECs, and be accountable for eTMF implementation and management.
  • Develop clinical monitoring strategies, generate and use metric reporting (CTMS, query trends, monitoring reports) to ensure timelines and data quality, and collaborate with data management on cleaning timelines.
  • Collaborate with PM, CRAs and QA to develop and implement CAPAs, assist sites and staff with GCP audit preparation, and escalate CRA performance or site compliance issues as needed.
  • Manage investigational product processes (drug accountability/reconciliation), and—when needed—assume project management responsibilities, negotiate site budgets/contracts, manage clinical vendors, support business development, and perform or oversee clinical data reviews and line management tasks.

Requirements

  • Bachelor’s degree or equivalent combination of education/experience in a science or health-related field; advanced degree preferred.
  • Minimum 5–8 years of clinical research experience with significant clinical monitoring experience.
  • Oncology Phase I trial experience in Australia preferred.
  • Experience preparing study documents, site start-up and feasibility activities, and developing monitoring strategies.
  • Experience with Microsoft Office products (Outlook, Word, Excel, PowerPoint).
  • Excellent communication, interpersonal and organizational skills, attention to detail, and a customer-service orientation.
  • Ability to travel domestically and internationally, including overnight stays.
  • Willingness to support business development and to assume project management or line management responsibilities as required.

Interested in this position?

Apply directly on the company website

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