Medical Monitor

2 hours, 10 minutes ago
Full-time
Mid Level
Operations
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986

Description

  • Provide unbiased medical guidance to clinical sites and internal and external study operations teams.
  • Support clinical safety, project, and data management by reviewing critical study materials at study start-up and throughout the study.
  • Review data listings, interim data sets, and final data sets to identify safety issues, gaps, and follow-up needs.
  • Provide medical guidance on protocol compliance, patient eligibility, investigational product questions, and protocol ambiguities.
  • Review out-of-range laboratory values, cumulative laboratory values, and protocol deviation data according to study-specific procedures.
  • Create and follow a study-specific medical monitoring plan when applicable.
  • Participate in the development, review, and finalization of protocols, amendments, Clinical Study Reports, and study plans.
  • Provide medical input into data collection tools, feasibility, site selection, and site initiation activities.
  • Attend, lead, and contribute to medical monitoring teleconferences and cross-functional study discussions.
  • Develop and deliver therapeutic, compound, investigator, and internal training materials and presentations.

Requirements

  • Medical degree required.
  • 4-6 years of related experience, with substantial ongoing job-related training.
  • Strong understanding of the drug development process, ICH, and Good Clinical Practice (GCP).
  • Strong written, verbal communication, and presentation skills.
  • Ability to exercise sound clinical judgment in complex and unexpected trial situations.
  • Strong analytical and critical thinking skills for reviewing patient data and identifying safety signals.
  • Previous experience in clinical trials preferred, especially in a CRO environment.
  • Must be fluent in English.
  • Experience with medical monitoring, protocol review, or clinical study reporting is preferred.
  • Ability to work effectively with internal teams, sponsors, and external study personnel.

Benefits

  • $99,500 - $166,000 annual salary.
  • Bonus eligibility.
  • Remote work arrangement.
  • Full-time, permanent position.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Team Coordinator

TSMG Professional Services

Team Coordinator for a remote AI/ML data collection and device testing project in Denmark, supporting participant operations and session coordination for medical consumer device usability studies.

Machine Learning
10 minutes ago

Energy Savings Assistance Field Trainer

Resource Innovations 251-1K Renewable Electricity

Resource Innovations is hiring an ESAP Field Trainer in California to provide hands-on contractor training, technical support, and quality oversight for weatherization work in PG&E territory.

CRM Salesforce
10 minutes ago

Client Operations Specialist (1770035824-T1-PH-S1) - Remote PH

A boutique wealth management firm is hiring a remote client service and operations specialist to support advisors with account administration, custodial processes, and high-touch client service.

10 minutes ago

Programming Specialist

Tech Firefly 251-1K Internet Software & Services

The Programming Specialist supports Entertainment Partnerships at a media company by managing content licensing and programming operations across inbound titles, policy reviews, scheduling, and partner coordination.

SQL
25 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers