Full Job Description
Title: Medical Monitor
Location: Trenton, NJ
Start date: ASAP
The Medical Monitor works with stakeholders across the organization to design and monitor strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives in Fibrosis
The Medical Monitor reviews and interprets clinical data, guides appropriate recommendations and decisions, and contributes substantially to regulatory submissions.
Works with the relevant team members and partners to develop clinical protocols and related documents, including informed consent forms, data monitoring committee charters, investigator brochures, clinical study reports, and clinical regulatory documents including integrated summaries and clinical overviews.
In collaboration with pharmacovigilance, designs and implements safety monitoring plans for clinical trials.
Monitors one or more clinical trials for appropriate adherence to protocols, safety and experimental rigor.
Addresses relevant clinical queries from study sites.
In collaboration with the Clinical Trial Lead, writes responses to study-related Institutional review Board/Ethic Committee and Health Authority questions.
Reviews and cleans data from clinical trials.
Provides key contributions to clinical documents and deliverables in support of regulatory submissions.
Cultivates relationships with thought leaders and investigators, and gathers input on disease areas and design of clinical programs.
Provides clinical support to medical affairs and commercial colleagues.
Attend weekly update meeting with core team (PM, DM, stats)
Attend weekly meetings with CRO and/or other vendors Help CRO respond to site and HA questions about the protocol
Monthly review of Jreview and CRO data listings and QNET lab data. Attend monthly safety meetings with CRO
Review daily lab alerts and SAEs. Communicate with CRO regarding follow-up.
Monthly review of protocol deviations
Attend and present at Investigator meetings
Present study updates at CPT
Monthly participation in MST
DBL (final listing review, review of blinded TLF, review protocol deviations, participate in all DBL meetings)
CSR writing (review final TLFs, work with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings)
Topline results presentation
Other tasks may be required as determined during the project
MD/PhD required, preferably with an understanding of Fibrosis
At least 10 years of experience in clinical or translational research or in clinical practice in a relevant field.
Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results.
Understanding of the fundamentals of protocol development and execution, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock.
Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements.
Ability to work consistently in a matrixed environment with relevant teams such as operations, statistics, regulatory, pharmacovigilance and biomarkers.
The candidate should have excellent communication skills and experience delivering effective presentations on both technical and nontechnical subjects.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.