Do you want to be a part of a team that gives hope to patients with rare and life-threatening diseases?
Do you thrive in an innovative, growth-oriented environment?
At WEP Clinical, we are looking for an experienced Medical Monitor interested in joining us in an exciting phase of high growth and helping us shape the future of clinical research.
Role Objectives: The Medical Monitor acts as the key medical and scientific resource for clinical trial protocols and Expanded Access Programs (EAPs), supporting the accurate and effective execution of studies.
They provide guidance to investigators and internal/external teams to ensure proper implementation and adherence to study protocols.
The Ideal Candidate: Detail-orientedProactiveCollaborativeWhat You'll Do: Serve as the primary contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, ensuring consistent protocol interpretation and clarification.Monitor clinical trials and Expanded Access Programs (EAPs) to ensure participant safety, data accuracy, and protocol compliance, addressing medical issues as they arise.Lead conference calls with investigators to discuss inclusion/exclusion criteria and provide support for site selection and patient recruitment.Act as the primary medical expert for clinical trial protocols, ensuring full comprehension and adherence by investigators and study teams.Review adverse events (AEs), serious adverse events (SAEs), and safety-related reports to ensure timely documentation and reporting.Provide causality assessments of AEs, particularly for those requiring expedited reporting to regulatory authorities.Collaborate with Data Safety Monitoring Boards (DSMBs) and safety committees to evaluate ongoing trial data and ensure participant safety.Provide ongoing training and support to investigators, site staff, and teams on the protocol and therapeutic area.Contribute medical input on study design, endpoints, and trial methodology, and ensure alignment with protocol and treatment guidelines.Work with clinical operations, regulatory, and project management teams to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and safety reporting.What You'll Need: Medical Doctor (MD) degree or PhD in health-related field required.At least 5+ years of relevant clinical research experience, preferably medical monitoring.Ability to travel internationally and domestically up to 25%.Experience in EAP / CUP / NPP is preferred.Proven experience in protocol development, implementation, and interpretation.Experience in safety monitoring, adverse event reporting, and medical data review in the context of clinical trials.In-depth knowledge of clinical trial design, regulatory requirements, and drug development processes.Computer literacy and proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.What sets us apart: WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available.
WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team: WEP has many initiatives to encourage wellness, growth and development, and team relationships.
Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI: At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values.
We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include: Expanded Access Programs (EAPs)Named Patient Programs (NPPs)Clinical Trial Supplies (Comparator & Ancillaries)Wren Nursing (Clinical Trial Home Nursing & Clinical Education)Hospital Supply of Unlicensed MedicinesWEP Clinical is a smoke-free, drug-free, and alcohol-free work environment. WEP Clinical is an equal-opportunity employer.
WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual's race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law.
This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination.
WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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