Job Description

The 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

This role will be perfect for you if

:

You are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project You skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials You are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary

RESPONSIBILITIES

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Protocols and projects

More specifically, as required by the projects' scope of work, the Medical Monitor will:

Keep 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. Develop or review Medical Monitoring plan. Provide project team training on study protocol and/or therapeutic area/indication. Prepare for, attend, and present at Investigators' Meetings. Prepare for and attend Safety Review Meetings, as needed. Provide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters Provide ongoing medical support during the study to investigators, site personnel, and monitors Provide 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 Review lab critical values and alerts. Assess the impact of any prohibited medication taken on study and evaluate any appropriate action for the subject. Evaluate the appropriateness of any dropout subject replacement. Provide emergency unblinding code-break of randomized treatment assignment.

Medical advisory role (clinical sites)

Provides 24-hour, 7 days a week, on-call service for urgent trial-related safety issues, questions on the protocol, or other safety concerns. Provides first line contact for investigators, site personnel, and monitors regarding study related medical/safety issues and resolution of study protocol and subject eligibility issues. Provides advice to the clinical team staff / sites to answer any medical questions related to patient eligibility, and safety or clinical issues during the trial. Assesses the impact of any prohibited medication taken on study and evaluates any appropriate action for the subject. Evaluates the appropriateness of any dropout subject replacement.

Data Activities

Provide project-related medical consultation to the Indero project team members during business hours throughout the duration of the study. Escalate 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. Attend meetings with Indero project team members (PM, DM, stats, CRO) and/or Sponsor, as required. Verify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study. Review 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. Review protocol deviation listings to address potential safety concerns; perform impact assessment; and identify any potential trends. Review coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly. Assess if any stopping rule was met and evaluate any appropriate action or follow up with the subject, if applicable. Review clinical study report. Participate 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.

Safety Medical Monitoring and SAE Reporting Activities

Provide medical review of SAE form, and reviews SAE causality assigned by the Investigator. Write and/or review SAE narratives Work 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. Provide assistance in pharmacovigilance activities Assist Indero/Sponsor in choosing safety committee members. Serve as a non-voting member of the safety committee to convene and organize proceedings, as applicable. Develop operating guidelines in conjunction with committee members and submit these to Sponsor for review. Support business development activities with proposal development and sales presentations. Participate in feasibility discussions relating to specific project proposals. Assist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities. Perform other related duties as assigned or requested by the Chief Medical Officer.



Requirements:

PROFILE

Education

Medical degree; Completed residency training in Dermatology, is an asset

Experience

Minimum of 2 years of relevant experience in clinical research in a CRO, dermatology clinical trials, pharmaceutical, or biopharmaceutical company (Medical Monitor, Medical affairs, Medical Director, Safety).

Knowledge and skills

Excellent knowledge of the drug development process. Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus. Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment. Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities. Excellent verbal and written communication skills as well as interpersonal skills. Client-focused approach to work; Good knowledge of good clinical practices.


Our company:

The work environment

At 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.



In this position, you will be eligible for the following perks:

Flexible work schedule Permanent full-time position Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) Option to work from home anywhere in Canada or from our headquarters in Montreal (in accordance with company policies and public health directives) Ongoing learning and development

About Indero

Indero, 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 continues to grow and expand in North America and Europe.

Indero

is committed to providing equitable treatment and equal opportunity to all individuals. As such,

Indero

will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.



Description - Fr:



Relevant du Gestionnaire Moniteur medical, affaires medicales, le Moniteur medical ou le Moniteur medical II, Canada fournit un soutien medical et scientifique aux programmes de recherche clinique.

Ce poste sera parfait pour vous si

:

Vous etes habile a etablir des relations de travail positives avec toutes les parties prenantes (sites cliniques, collegues, sponsors ) dans un projet de recherche clinique. Vous equilibrez habilement les exigences strictes des protocoles de recherche clinique avec les realites des essais cliniques. Vous etes capable d'interpreter efficacement de gros volumes de donnees et de situations, de prendre position et de conseiller si necessaire.

RESPONSABILITES

Protocoles et projets

Se tient au courant du protocole de l'etude, des modifications du protocole de l'etude, de la brochure de l'investigateur (IB), des informations de securite supplementaires mises a disposition au cours de l'etude et des directives de recherche clinique pertinentes impliquant l'indication therapeutique. Elabore ou examine le plan de surveillance medicale et examine le plan de rapport de securite le cas echeant. Fournit une formation a l'equipe de projet sur le protocole d'etude et / ou les domaines therapeutiques. Se prepare aux reunions d'enqueteurs et y assiste. Fournit une consultation medicale liee au projet aux membres de l'equipe de projet Innovaderm (pendant les heures normales de bureau) pendant toute la duree de l'etude. Participe aux activites liees au developpement des affaires au besoin.

Role de conseil medical (sites cliniques)

Fournit un service de garde 24 heures sur 24, 7 jours sur 7 pour les problemes de securite urgents lies aux essais, les questions sur le protocole ou d'autres problemes de securite. Fournit un contact de premiere ligne pour les investigateurs, le personnel du site et les moniteurs concernant les problemes medicaux / de securite lies a l'etude et la resolution du protocole d'etude et les problemes d'eligibilite des sujets. Fournit des conseils au personnel / aux sites de l'equipe clinique pour repondre a toutes les questions medicales liees a l'eligibilite des patients et aux problemes de securite ou cliniques pendant l'essai. Evalue l'impact de tout medicament interdit pris sur l'etude et evalue toute action appropriee pour le sujet. Evalue la pertinence de tout remplacement de sujet. Participe activement dans des rencontres de developpement des affaires Agit a titre de conseiller et d'expert en la matiere pour des taches demandant une expertise medicale en dermatologie (revue de documents, conseiller des collegues, partenaires et clients).

Activites de donnees

Examiner les listes de donnees relatives a la securite afin d'identifier les tendances potentielles, les ecarts de protocole non signales lies aux evaluations de la securite, aux EI et aux EIG; et aborder les problemes de securite. Evalue si une regle d'arret a ete respectee et evalue toute action appropriee ou suivi avec le sujet, le cas echeant. Examine les alertes des laboratoires et coordonne le suivi approprie avec les sites d'etude. Examine des parties du rapport d'etude clinique, au besoin. Escalade au gestionnaire de projet ou au sponsor tout probleme necessitant une intervention medicale et des problemes importants de securite ou d'integrite des donnees identifies lors de l'examen des donnees ou du contact avec le site.

Activites de surveillance medicale de securite et de rapport SAE

Verifie l'exactitude medicale des donnees de securite du sujet et maintient une evaluation continue du profil de securite de l'etude. Fournit une rupture de code d'urgence de liberation de l'insu de l'assignation de traitement aleatoire, le cas echeant.


Profil recherche:

PROFIL RECHERCHE

Education

Diplome de medecine (MD). Les candidats avec une education et une formation en medecine complete a l'exterieur du Canada sont consideres et encourages a postuler. Notez que ce poste

ne requiert pas

de permis pour pratique (role de medecin non pratiquant).

Experience

Minimum de 2 annees d"experience pertinente en recherche clinique dans un CRO, en etudes cliniques en dermatologie, une compagnie pharmaceutique ou biopharmaceutique (Medecin moniteur, affaires medicales, directeur medical, securite medicale).

Aptitudes et connaissances

Excellentes competences en communication orale et ecrite en anglais, le francais est un atout majeur. Excellente connaissance du processus de developpement des medicaments et des bonnes pratiques cliniques. Solides competences interpersonnelles et capacite a communiquer efficacement avec les sites, les collegues et les clients. Capacite a travailler en partenariat avec un groupe multidisciplinaire de collegues, y compris la traduction de concepts en approches pratiques et la promotion du consensus. Capacite exceptionnelle a travailler de maniere autonome avec un minimum de supervision, capacite a travailler efficacement au sein d'une equipe et environnement matriciel. Capacite a organiser et a travailler efficacement sur plusieurs projets, chacun avec des exigences specifiques et / ou des priorites changeantes.



Notre entreprise:

NOTRE ENTREPRISE

L'environnement de travail

Chez Indero, vous travaillerez avec des collaborateurs competents et dynamiques. Nos valeurs sont la collaboration, l'innovation, la fiabilite et la reactivite. Nous offrons un environnement de travail stimulant et des possibilites d'avancement interessantes.



Dans ce poste, vous beneficierez des conditions suivantes :

Flexibilite sur l'horaire Poste permanent a temps plein Gamme d'avantages sociaux (assurances medicales, dentaire, vision, regime de retraite, vacances, journees personnelles, clinique medicale virtuelle, rabais sur le transport en commun, activites sociales) Option de travailler a la maison (au Canada), ou a partir de nos bureaux a Montreal (en fonction des politiques de l'entreprise et des directives de la sante publique). Formation et developpement continu

A propos d'Indero

Indero est une entreprise de recherche clinique contractuelle (CRO) specialisee en dermatologie. Depuis ses debuts en 2000, notre entreprise a taille humaine beneficie d'une solide reputation autant pour la qualite de la recherche effectuee que pour la qualite des soins offerts, depassant les attentes de ses clients. Base a Montreal, Indero continue aujourd'hui sa croissance en Amerique du Nord et en Europe.

Indero s'engage a assurer une approche equitable ainsi que des opportunites equivalentes pour tous les candidats. A ce titre, Indero fournira sur demande des accommodations aux candidats ayant un handicap, et ce, a travers toutes les etapes du processus de recrutement, si demande.

Indero accepte uniquement les candidats pouvant legalement travailler au Canada.

Le genre masculin est utilise sans discrimination et dans le seul but d'alleger le texte.



Brand name:


Indero