PpThe Medical Monitor Dermatology provides medical and scientific support to clinical research programs. The Medical Monitor will perform thorough data review to ensure data integrity and subject safety oversight, and will communicate with sites, investigators, and internal project team members to ensure questions are promptly addressed. /p h3This role will be perfect for you if /h3 ul liYou are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project /li liYou skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials /li liYou are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary /li /ul h3Responsibilities /h3 h3Protocols and projects /h3 ul liKeep current on study protocol, study protocol amendments, Investigator’s Brochure (IB), additional safety information made available during the course of the study, and relevant clinical research guidelines involving the therapeutic indication. /li liDevelop or review Medical Monitoring plan. /li liProvide project team training on study protocol and/or therapeutic area/indication. /li liPrepare for, attend, and present at Investigators’ Meetings. /li liPrepare for and attend Safety Review Meetings, as needed. /li liProvide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters. /li liProvide ongoing medical support during the study to investigators, site personnel, and monitors. /li liProvide advice to the sites on protocol-related issues including questions related to the protocol inclusion and exclusion criteria, concomitant medications/medical conditions, follow-up visits due and guidance on prohibited medication. /li liReview lab critical values and alerts. /li liAssess the impact of any prohibited medication taken on study and evaluate any appropriate action for the subject. /li liEvaluate the appropriateness of any dropout subject replacement. /li liProvide emergency unblinding code‑break of randomized treatment assignment. /li /ul h3Medical advisory role (clinical sites) /h3 ul liProvides 24-hour, 7 days a week, on-call service for urgent trial‑related safety issues, questions on the protocol, or other safety concerns. /li liProvides first line contact for investigators, site personnel, and monitors regarding study related medical/safety issues and resolution of study protocol and subject eligibility issues. /li liProvides advice to the clinical team staff / sites to answer any medical questions related to patient eligibility, and safety or clinical issues during the trial. /li liAssesses the impact of any prohibited medication taken on study and evaluates any appropriate action for the subject. /li liEvaluates the appropriateness of any dropout subject replacement. /li /ul h3Data Activities /h3 ul liProvide project-related medical consultation to the Indero, formerly Innovaderm project team members during business hours throughout the duration of the study. /li liEscalate to the Project Manager or Sponsor any issues requiring medical input and significant safety or data integrity concerns identified during review of data or site contact. /li liAttend meetings with Indero, formerly Innovaderm project team members (PM, DM, stats, CRO) and/or Sponsor, as required. /li liVerify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study. /li liReview subject safety‑related data listings/tools for the purpose of identifying potential trends, unreported protocol deviations related to safety assessments, AEs, and SAEs; and address safety concerns. /li liReview protocol deviation listings to address potential safety concerns; perform impact assessment; and identify any potential trends. /li liReview coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly. /li liAssess if any stopping rule was met and evaluate any appropriate action or follow up with the subject, if applicable. /li liReview clinical study report. /li liParticipate in the Central Monitoring activities with site data signal detection and risk management activities for the safety portion; participate in the safety review for RBM and central monitoring. /li /ul h3Safety Medical Monitoring and SAE Reporting Activities /h3 ul liProvide medical review of SAE form, and reviews SAE causality assigned by the Investigator. /li liWrite and/or review SAE narratives. /li liWork with the Pharmacovigilance Services provider or Marketing Authorization Holder (MAH) to review SAEs and follow-up on outstanding safety queries, interact with Sponsor and discuss safety issues with sites, as needed. /li liProvide assistance in pharmacovigilance activities. /li liAssist Indero, formerly Innovaderm/Sponsor in choosing safety committee members. /li liServe as a non‑voting member of the safety committee to convene and organize proceedings, as applicable. /li liDevelop operating guidelines in conjunction with committee members and submit these to Sponsor for review. /li liSupport business development activities with proposal development and sales presentations. /li liParticipate in feasibility discussions relating to specific project proposals. /li liAssist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities. /li liPerform other related duties as assigned or requested by the Chief Medical Officer. /li /ul h3Requirements /h3 h3Education /h3 ul liMedical degree; /li liCompleted residency training in Dermatology is an asset. /li /ul h3Experience /h3 ul liMinimum of 5 years of relevant experience in clinical research in a CRO, pharmaceutical, or biopharmaceutical company (Medical Monitor, Medical affairs, Medical Director, Safety). /li liMinimum 3 years experience in CRO or pharmaceutical industry in clinical research, with experience as medical monitor/medical reviewer/drug safety physician for clinical trials. /li /ul h3Knowledge And Skills /h3 ul liExcellent knowledge of the drug development process. /li liAbility to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus. /li liOutstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment. /li liAbility to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities. /li liExcellent verbal and written communication skills as well as interpersonal skills. /li liClient-focused approach to work. /li liGood knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. /li /ul h3Our company /h3 pAt Indero, formerly Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. /p h3Perks /h3 ul liPermanent full‑time position /li liFlexible schedule /li liHome‑based position /li liOngoing learning and development /li /ul h3Work location /h3 pThe successful candidate for this position is given to work remotely anywhere in Spain or Poland. /p h3About Indero, formerly Innovaderm /h3 pIndero, formerly Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formerly Innovaderm continues to grow and expand in North America and Europe. /p pIndero, formerly Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals; Indero, formerly Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero, formerly Innovaderm only accepts applicants who can legally work in Spain or Poland. /p /p #J-18808-Ljbffr