PMedical Monitor, Dermatology, Poland or Spain About The Position /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. /ppbThis role will be perfect for you if : /b /pulliYou are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project. /liliYou skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials. /liliYou are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary. /li /ulpRESPONSIBILITIES /ppbProtocols and projects /b /ppMore specifically, as required by the projects’ scope of work, the Medical Monitor will : /pulliKeep 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. /liliDevelop or review Medical Monitoring plan. /liliProvide project team training on study protocol and / or therapeutic area / indication. /liliPrepare for, attend, and present at Investigators’ Meetings. /liliPrepare for and attend Safety Review Meetings, as needed. /liliProvide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters. /liliProvide ongoing medical support during the study to investigators, site personnel, and monitors. /liliProvide 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. /liliReview lab critical values and alerts. /liliAssess the impact of any prohibited medication taken on study and evaluate any appropriate action for the subject. /liliEvaluate the appropriateness of any dropout subject replacement. /liliProvide emergency unblinding code-break of randomized treatment assignment. /li /ulpbMedical advisory role (clinical sites) /b /pulliProvides 24-hour, 7 days a week, on-call service for urgent trial-related safety issues, questions on the protocol, or other safety concerns. /liliProvides first line contact for investigators, site personnel, and monitors regarding study related medical / safety issues and resolution of study protocol and subject eligibility issues. /liliProvides advice to the clinical team staff / sites to answer any medical questions related to patient eligibility, and safety or clinical issues during the trial. /liliAssesses the impact of any prohibited medication taken on study and evaluates any appropriate action for the subject. /liliEvaluates the appropriateness of any dropout subject replacement. /li /ulpbData Activities /b /pulliProvide project-related medical consultation to the Innovaderm project team members during business hours throughout the duration of the study. /liliEscalate 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. /liliAttend meetings with Innovaderm project team members (PM, DM, stats, CRO) and / or Sponsor, as required. /liliVerify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study. /liliReview 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. /liliReview protocol deviation listings to address potential safety concerns; perform impact assessment; and identify any potential trends. /liliReview coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly. /liliAssess if any stopping rule was met and evaluate any appropriate action or follow up with the subject, if applicable. /liliReview clinical study report. /liliParticipate 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 /ulpbSafety Medical Monitoring and SAE Reporting Activities /b /pulliProvide medical review of SAE form, and reviews SAE causality assigned by the Investigator. /liliWrite and / or review SAE narratives. /liliWork 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. /liliProvide assistance in pharmacovigilance activities. /liliAssist Innovaderm / Sponsor in choosing safety committee members. /liliServe as a non-voting member of the safety committee to convene and organize proceedings, as applicable. /liliDevelop operating guidelines in conjunction with committee members and submit these to Sponsor for review. /liliSupport business development activities with proposal development and sales presentations. /liliParticipate in feasibility discussions relating to specific project proposals. /liliAssist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities. /liliPerform other related duties as assigned or requested by the Chief Medical Officer. /li /ulpRequirements /ppEducation /ppbExperience /b /pulliMinimum of 5 years of relevant experience in clinical research in a CRO, pharmaceutical, or biopharmaceutical company (Medical Monitor, Medical affairs, Medical Director, Safety). /liliMinimum 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 /ulpbKnowledge and skills /b /pulliExcellent knowledge of the drug development process. /liliAbility to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus. /liliOutstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment. /liliAbility to organize and work efficiently on several projects, each with specific requirements and / or shifting priorities. /liliExcellent verbal and written communication skills as well as interpersonal skills. /liliClient-focused approach to work. /liliGood knowledge of good clinical practices. /li /ulpbOur company /b /ppAt 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. /ppAs a Medical Monitor, you will be eligible for the following perks : /pulliPermanent full-time position. /liliHome-based position. /liliOngoing learning and development. /li /ulpbWork location /b /ppThe successful candidate for this position is given to work remotely anywhere in Spain or Poland. /ppbAbout Innovaderm /b /ppInnovaderm 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, Innovaderm continues to grow and expand in North America and Europe. /ppInnovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. /ppInnovaderm only accepts applicants who can legally work in Spain or Poland. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr