Medical Monitor- Oncology Research
Clinical | (Remote) | Full Time
We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move your medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide your therapy through the most critical development milestones from the lab to planning your regulatory and clinical strategy. Our ultimate goal? To help patients.
The Medical Monitor (MM) provides medical expertise and oversight for clinical research trials. The MM ensures the clinical integrity of trial subjects, provides patient safety accountability, and is an expert medical reference for investigative sites and trial team members. The MM helps to ensure that each research trial is in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and meets overall clinical objectives.
Review protocol, protocol amendments, Investigational Brochure, and any other applicable trial documents during initial trial design through trial close.
Respond to site and Health Authority questions about the protocol and study design.
Review and contribute to creation of clinical trial plans such as the Medical Monitoring Plan and Safety Management Plan.
Participate in trial risk assessment and mitigation planning.
Attend project Kick-off Meetings (KOMs) and Site Initiation Visits (SIVs) as requested by the Sponsor.
Serve as physician-to-physician contact for Investigator sites, provide medical expertise for questions, and resolve trial-related issues for items such as patient eligibility, inclusion/exclusion criteria, and patient safety.
Attend ad-hoc teleconferences and routine meetings with the TD2 project team, Sponsor, PI, and/or clinical trial site staff as requested to discuss and provide guidance on patient dosing, adverse events, protocol outcomes, overall medical safety and other issues related to the study.
Conduct routine review of study data in a variety of formats, including electronic and/or paper Case Report Forms (CRF).
Review patient safety data throughout the clinical trial, including review of laboratory results, adverse events (AEs), serious adverse events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and/or complex clinical events. Respond to safety events and queries from safety personnel within specified reporting timeframes. Ensure accuracy of SAE attribution and severity.
Attend and present data at clinical trial safety and dose escalation meetings and participate in discussions for recommendations of dose modifications.
Perform medical coding review and approve coded terms.
Review research site prospective clinical protocol deviation requests and provide guidance on actions as needed.
Use medical and oncology expertise to participate in drug development strategy for clinical trials. Provide medical guidance on trial design during client calls and bid defense meetings.
Assist with selection of new employee and contract MMs, including mentoring and training as needed.
Work in a matrix environment, interacting with the entire Clinical Operations team and leadership of other TD2 departments. Participate in scientific and medical training for the TD2 team.
Contribute information and/or review of information for industry meetings or publications as requested.
Maintain appropriate MM training requirements as per the TD2 Training Matrix to include:
Good Clinical Practice (GCP)
Health Privacy (HIPAA)
Human Subjects in Research
Review of project specific protocol and Investigational Brochure
Applicable TD2 SOPs and CWGs
Perform other related duties as assigned.
MD or DO degree with experience in oncology and pharmacovigilance/medical safety required.
Minimum of 3 years’ of pharmaceutical industry experience, of which at least 2 years must be in the field of oncology and 1 year must be in pharmacovigilance or related area.
Required Specialized/Technical Skills:
Fully trained in all aspects of investigational clinical trials and experience as a medical monitor (Phases I–IV).
Ability to critically evaluate medical/scientific information and provide feedback.
Experience managing projects in a matrix environment, coordinating activities, and adhering to tight timelines.
Knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials.
Proven ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches.
Proven experience working in cross-functional project teams.
Excellent verbal and written communication with strong interpersonal skills.
Experience with Microsoft Office tools and applicable business software.
Must be leadership oriented.
Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.