DOCS Clinical Trial Manager in Topeka, Kansas
Clinical Trial Manager
Ref #: 23611
Employment type: Permanent - Full-Time
Location: US - Nationwide (home-based)
DOCS is searching for Clinical Trial Managers for global execution of clinical trials within Oncology, Pulmonary Hypertension, Infectious Disease or Vaccines, within agreed timelines and budget, in alignment with all the applicable SOPs and regulatory requirements. This is home-based position for someone with 4-8 years of global trial management experience from a CRO or Pharmaceutical company.
Main focus is on trial management supervision, planning and coordination. Includes trial set-up, execution, analysis and reporting (includes trial closure) and post-study activities. Measures study progress against agreed upon timelines to milestones.
Ensure accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes.
Ensure enrollment commitments meet the projected enrollment across the regions at the clinical trial level, monitors patient recruitment at the global level, and ensure timely and accurate documentation and communication of study progress and issue escalation.
Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes.
Ensure deliverables are carried out according to the trial plan. Provides updates to all appropriate Clinical Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status according to trial plan.
Strong interaction with cross-functional teams and external vendor groups.
Must have a BA/BS or higher education
4-8 years of Clinical Operations Management experience.
At least 3 years of experience managing global trials and teams in a virtual environment
Vendor Management/CRO Management experience required
Clinical Trial Management experience in one of the following areas is required: Oncology, Pulmonary Hypertension, Infectious Disease or Vaccines.
DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment