In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms. You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study.
Medical Oversight
- Provide clarity on general protocol questions, and medical guidance for protocols as required.
- Serve as medical expert providing guidance on patient eligibility, and investigational product related questions.
- Document contacts in accordance with Alimentiv or study specific procedures.
- Consult with Alimentiv Medical Director(s), Sponsor Medical group and/or Safety about medical questions pertaining to the indication/compound under study.
- Observe and identify safety issues and other trends as appropriate.
- Provide consultation on the unbinding of trial participants/site staff to subject treatment allocation.
- Review individual, out of range laboratory values following study-specific laboratory guidelines and alert values (as appropriate). Review cumulative laboratory values according to the study plans.
- Review protocol deviation data and recommend protocol changes as appropriate.
- Create and follow a study-specific medical monitoring plan if applicable.
- Provide medical review of study level data, to identify gaps and areas requiring additional safety-related follow-up.
- Participate in the development, review and finalization of protocols, amendments, Clinical Study Reports, as required.
- Provide medical input into data collection tools, study plans (e.g., monitoring, statistical analysis plans, etc.).
- Provide medical input into study feasibility, site selection and site initiations as required.
- Attend and lead medical monitoring teleconferences at regularly scheduled intervals throughout the study, if required.
Knowledge
- Maintain a thorough working knowledge of protocol(s) and the current Investigator Brochure(s) with particular attention to those aspects relating to safety data involving human subjects.
Training
- Participates in the development and maintenance of medical educational materials.
- Provide internal training to Alimentiv operational teams on specific diseases, drug targets, pharmacology, protocol requirements etc., as needed to support execution of client studies or general acquisition to appropriate medical knowledge as required by the organization.
- Assist with the development of investigator training and meeting support materials.
- Attend and present at investigator meetings and CRA training meetings.
Qualifications
- The successful candidate must have a medical degree with a strong understanding of the drug development process, ICH and Good Clinical Practices. Typically, this person will hold about 4-6 years of related experience with substantial on-going job-related training.
- Strong written and verbal communication and presentation skills, enabling effective interactions with team members within Alimentiv, client company personnel and prospective sponsors.
- You must have the ability to exercise sound clinical judgment in addressing protocol ambiguities and unforeseen medical scenarios that arise during trial conduct. Strong analytical and critical thinking skills are essential for identifying safety signals, evaluating complex patient data, and recognizing emerging trends across study populations to ensure subject protection and data integrity.
- Previous experience in clinical trials is preferred especially in navigating complex medical scenarios within a CRO environment.
- Must be fluent in English.