Medical Monitor Associate Job in Ellicott City, Maryland US
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. In a highly fragmented industry, we are one of a small group of organizations with the capability and expertise to conduct clinical trials and development projects on either a local or global basis. We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated "full service" solution.
The successful candidate will assist the Medical Monitor in communications between clinical study site and project staff regarding protocol questions; assist with the review and interpretation of clinical study data; writing, editing, compiling and QC of documents; ensuring the accuracy and quality of applicable written deliverables, and of scientific and clinical research, review, and medical monitoring activities.,
Role Responsibility
- Assist the Medical Monitor in communications between study site, ICON project staff, and sponsors regarding protocol or other study-related questions, including documenting, tracking, following-up on all issues
- Assist the Medical Monitor in the review, analysis and interpretation of data from clinical studies, including data files, tables, figures and listings
- Assist the Medical Monitor in the writing, review, editing and QC of applicable documents, including proposals, synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, case report forms, data validation specifications, manuscripts, clinical development plans and analysis plans, ensuring that they meet scientific and regulatory standards as applicable
Oversee or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review or other study-related meetings
- Assist in preparing scientific, process and capability presentations for prospective clients (Business Development, Bid Defense) and for presenting at conferences and professional meetings
- Participate in and/or lead process improvement initiatives such as establishing and improving document standards, process mapping documentation, SOP authoring, review and revision, gap analysis and resolution of department training plans SOPs or other procedures
- Participate and assist management in defining and managing applicable cost models, project timelines and budgets, and improve efficiencies of processes with respect to quality, cost and time
Assist in growing and managing the CRD resource library (eRoom), including relevant literature, example documents, style guides and templates
- Resolve issues and escalate problems as necessary
- Undertake other reasonably related duties as may be assigned from time to time.
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (10%) domestic and/or international
Experience Qualification
- BS/BA in a biomedical science plus additional medical and/or relevant scientific education. Advanced degree (Masters, PhD, MD, or local equivalent) a strong plus
- Minimum of 4 years of relevant experience in early clinical drug development, clinical pharmacology, clinical research, regulatory science and preparing applicable clinical research documentation in a pharmaceutical company and/or CRO environment.
- Knowledge of scientific and regulatory requirements applicable to early phase clinical studies
- Excellent written and verbal communication skills, clinical data-interpretation skills, strong interpersonal and leadership skills, ability to independently plan, organize, prioritize and multi-task in a fast-paced environment.
- Excellent computer skills to include MS Word, Excel, PowerPoint, Visio; scientific graphing (e.g. SigmaPlot, Origin, Prism, Patient Profiles) a plus
Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive compensation and an exceptional benefits package that includes: Medical, Dental, and Vision Insurance, Flexible Spending Accounts, Short Term and Long Term Disability, Life and ADD Insurance, 401K Plan with matching contributions, a generous program of Vacation, Holidays and Personal Time Off and more.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.