Medical Monitor, EU
For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.
Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.
We do things differently than large CROs and would love to have you join our Veristat team!
The Medical Monitor serves as the medical expert for assigned clinical trials. S/he is responsible to provide input into the design and conduct of clinical trials, review and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc), assess and interpret safety data, and contribute to investigator, other site staff and clinical study team training. The Medical Monitor is the main point of contact for Investigators for medical and protocol related questions. S/he will provide medical knowledge and expertise to the day-to-day operations of clinical research studies by answering medical questions coming from the study team.
The Medical Monitor will also assist the department head in the development and execution of patient safety and pharmacovigilance activities. S/he must provide oversight of study patients’ safety matters. S/he works closely with other departments, sponsors, and investigator sites to ensure that proper plans are in place to ensure proper medical oversight.
As a Medical Monitor You Will...
- Work as primary or back-up Medical Monitor for assigned clinical trials which includes being readily available to advise on trial related medical questions or problems during the conduct of the trial.
- Be responsible for reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting.
- Provide review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
- Consult with internal and external stakeholders and experts to assist in the development and assisting in the design and conduct of clinical trials including the drafting of protocols and amendments.
- Assist with business development activities, including participation in bid defenses, and the development of business proposals as it pertains to Medical Affairs.
- Develop and/or review operational, medical monitoring, and safety plans for awarded studies.
- Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection.
- Lead and/or participate in scientific and medical training to other Veristat team members and outside clients, investigators, and other site staff as it pertains to assigned studies.
- Monitor patient safety by acting as a medical monitor and/or in the development and conduct of a DSMB.
- Ensure activities related to SAEs are conducted in accordance with applicable SOP’s and regulations.
- Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
- Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
- Liaise with investigator and Safety Manager to review AEs/SAEs on behalf of the Sponsor.
- Work within the Medical Affairs team to ensure compliance with applicable regulations and standard operating procedures.
- Assist in the development and maintenance of standard documents regarding safety and medical monitoring processes and procedures.
- Support and participate in other activities of other divisions in the Medical Affairs department as applicable, including but not limited to medical coding.
- Lead by example and model core values in all actions; ensure a positive, respectful team environment, fostering collaboration and development.
Experience & Minimum Requirements:
- Doctor of Medicine (MD) with strong leadership skills including a minimum of 5 years direct experience in the pharmaceutical industry, preferably in a medical monitoring role, required.
- Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.
- US and EU experience preferred.
- Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
- Excellent project management skills, written and oral communication, organizational, and interpersonal skills are required.
- Proficiency in English (written and verbal) required.
- Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities.
- Action-oriented and resilient in a fast-paced environment and with the ability to build and lead effective project teams, motivate others, delegate, and make and implement decisions in a matrixed environment.
- Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members.
- Ability to mentor and delegate.