Strategist, Patient Recruitment

2 months ago


Montreal, Canada Innovaderm Research Full time

The Strategist, Patient Recruitment & Site Engagement works with the Associate Director, Patient recruitment and the Specialist, Digital Marketing Specialist in supporting patient recruitment strategies and site engagement.



This role will be perfect for you if:

  • Have experience with patient recruitment programs and strategy
  • Have experience with NA and EU clinical trials
  • You understand GDPR and EU regulations for clinical trials and you are able to support US/CAN studies
  • Have experience as a study coordinator at a large study site managing multiple trials


More specifically, the Strategist, Patient Recruitment and Site Engagement must:


  • Develop the project level recruitment strategy plan in collaboration with the Patient Recruitment Team.
  • Inform and train project team on recruitment strategy in collaboration with the Project Manager and/or CTM.
  • Participate in BD handover, Kick off Meeting as well as Investigator meeting.
  • Attend internal and external core and cross-functional team meetings.
  • Provide patient recruitment training slides for SIV and/or CRA training.
  • Develop site recruitment materials based on approved recruitment strategy.
  • Work in collaboration with regulatory team to obtain approval of materials.
  • Manage translations through the selected vendor(s) or local qualified translators and review of recruitment materials, where applicable.
  • Manage distribution of materials to sites, where applicable.
  • Monitor the progression of subject enrolment to ensure the target can be achieved and propose improvements in recruitment and retention strategies, as necessary, in collaboration with the Project Manager/CTM and/or clinical team. Identify risks, and plan risk management strategies.
  • Work collaboratively with the clinical team for site communication and support.
  • Collaborate with Project Team members to create recruitment models based on information obtained during feasibility, site initiation, actual recruitment performance.
  • Assists the Project Manager on client’s request for recruitment and advertisement.
  • Interacts directly with clients to establish and gain client input on recruitment strategies and budgets.
  • When applicable, offers guidance to sites on ways to achieve their recruitment target using their advertisement budget.
  • When applicable, review site advertisement for alignment to protocol and obtains Sponsor approval.
  • When applicable, ensure the assigned study has been set-up and maintained appropriately in Clinago as per internal processes. 
  • When applicable, ensure sites are onboarded and trained on the Clinago platform for central campaign initiative.
  • When applicable, work with sites and monitor referrals from central campaign to ensure follow up is occurring at the site level.
  • Ensure that all project relevant documentation is sent for filing in eTMF and archiving.
  • Coordinate global advertisement IRB submission and approval process.


Our company:


OUR COMPANY

 

The work environment

 

At 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)
  • Possibility of working from home in Canada or from our headquarters in Montreal
  • Ongoing learning and development

 

 

About Innovaderm

 

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

 

 

Innovaderm 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.

 

Innovaderm only accepts applicants who can legally work in Canada.



Description - Fr:

Le stratégiste. recrutement de patients et engagement des sites, travaille avec le directeur associé du recrutement des patients et le spécialiste du marketing numérique pour soutenir les stratégies de recrutement des patients et l'engagement des sites,


Ce rôle sera parfait pour vous si :


  • Vous avez de l'expérience en matière de programmes et de stratégies de recrutement de patients
  • Vous avez de l'expérience en matière d'essais cliniques en Amérique du Nord et dans l'Union européenne.
  • Vous comprenez les réglementations GDPR et UE pour les essais cliniques et vous êtes en mesure de soutenir les études US/CAN.
  • Vous avez de l'expérience en tant que coordonnateur d'étude sur un grand site d'étude gérant plusieurs essais.


Plus précisément, le stratégiste, recrutement de patients et engagement des sites doit :


  • Élaborer le plan de stratégie de recrutement au niveau du projet en collaboration avec l'équipe de recrutement de patients. 
  • Informer et former l'équipe de projet sur la stratégie de recrutement en collaboration avec le chef de projet et/ou le responsable des essais cliniques (CTM).
  • Participer à la remise des BD, à la réunion aux réunions de lancement ainsi qu'à la réunion des investigateurs.
  • Participer aux réunions internes et esternes de l'équipe principale et de l'équipe interfonctionnelle
  • Préparer des présentations PowerPoint de formation sur le recrutement des patients pour la visite d'initiation et ARC.
  • Élaborer des documents de recrutement pour le site sur la base de la stratégie de recrutement approuvée.
  • Travailler en collaboation avec l'équipe règlementaire pour obtenir l'approbation des documents
  • Gérer les traductions par l'intermédiaire du (des) fournisseur(s) sélectionné(s) ou de traducteurs locaux qualifiés et réviser le matériel de recrutement, le cas échéant.
  • Gérer la distribution du matériel aux sites, le cas échéant.
  • Suivre la progression du recrutement des sujets pour s'assurer que l'objectif peut être atteint et proposer des améliorations dans les stratégies de recrutement et de rétention, si nécessaire, en collaboration avec le chef de projet/CTM et/ou l'équipe clinique. Identifier les risques et planifier des stratégies de gestion des risques.
  • Travailler en collaboration avec l'équipe clinique pour la communication et le soutien au site.
  • Collaborer avec les membres de l'équipe de projet pour créer des modèles de recrutement fondés sur les informations obtenues lors de l'étude de faisabilité, de l'ouverture du site et des performances réelles en matière de recrutement.
  • Aider le chef de projet à répondre aux demandes de recrutement et de publicité du client
  • Interagir directement avec les clients pour établir et obtenir leur avis sur les stratégies et les budgets de recrutement.
  • Le cas échéant, donner des conseils aux sites sur la manière d'atteindre leur objectif de recrutement en utilisant leur budget publicitaire.
  • Le cas échéant, il révise la publicité du site pour s'assurer qu'elle est conforme au protocole et obtient l'approbation du client.
  • Le cas échéant, s'assure que l'étude assignée a été mise en place et maintenue de manière appropriée dans Clinago, conformément aux processus internes.
  • Le cas échéant, veille à ce que les sites soient intégrés et formés sur la plateforme Clinago pour l'initiative de campagne centrale.
  • Le cas échéant, travaille avec les sites et contrôle les références de la campagne centrale pour s'assurer que le suivi est effectué au niveau du site.
  • Veiller à ce que toute la documentation relative au projet soit envoyée pour être classée dans le système eTMF et archivée.
  • Coordonner le processus de soumission et d'approbation de l'IRB pour la publicité internationale.


Profil recherché:

PROFIL IDEAL



Éducation 

  • BA / BS requis, de préférence en communication ou dans un domaine connexe avec 3 ans d'expérience pertinente


Expérience 

  • Au moins deux ans d'expérience professionnelle pertinente dans le secteur des biotechnologies, de l'industrie pharmaceutique, desCRO ou dans le domaine de la santé et de la médecine.


Aptitudes et connaissances 

  • Connaissance des bonnes pratiques cliniques, des bonnes pratiques cliniques et des règlementations applicables.
  • Bonne connaissance des réglementations/directives européennes
  • Anglais parlé et écrit, espagnol ou français un atout
  • Expérience dans un environnement de site de recherche un atout
  • Expérience de la gestion d'un groupe de défense des patients, un atout
  • Expérience dans les stratégies de recrutement des patients
  • Aptitude à résoudre les problèmes, bonne capacité d'adaptation, polyvalence et grand souci du détail.
  • Solides compétences en matière d'organisation, de communication, de résolution de problèmes et d'exécution de tâches multiples.
  • Bonne connaissance des bonnes pratiques cliniques et des réglementations/directives applicables de Santé Canada et de la Food and Drug Administration (FDA).


Notre entreprise:

NOTRE ENTREPRISE

 

L’environnement de travail

 

Chez Innovaderm, vous travaillerez avec des collaborateurs compétents et dynamiques. Nos valeurs sont la collaboration, l’innovation, la fiabilité et la réactivité. Nous offrons un environnement de travail stimulant et des possibilités d’avancement intéressantes.

 

Dans ce poste, vous bénéficierez des conditions suivantes :

  • Flexibilité sur l’horaire
  • Poste permanent à temps plein
  • Gamme d’avantages sociaux (assurances médicales, dentaire, vision, régime de retraite, vacances, journées personnelles, clinique médicale virtuelle, rabais sur le transport en commun, activités sociales)
  • Possibilité de travail à la maison à long terme au Canada ou à nos bureaux à Montréal
  • Formation et développement continu

 

À propos d’Innovaderm

 

Innovaderm est une entreprise de recherche clinique contractuelle (CRO) spécialisée en dermatologie. Depuis ses débuts en 2000, notre entreprise à taille humaine bénéficie d’une solide réputation autant pour la qualité de la recherche effectuée que pour la qualité des soins offerts, dépassant les attentes de ses clients. Basé à Montréal, Innovaderm continue aujourd’hui sa croissance en Amérique du Nord et en Europe.

 

Innovaderm s’engage à assurer une approche équitable ainsi que des opportunités équivalentes pour tous les candidats. À ce titre, Innovaderm fournira sur demande des accommodations aux candidats ayant un handicap, et ce, à travers toutes les étapes du processus de recrutement, si demandé.

 

Innovaderm accepte uniquement les candidats pouvant légalement travailler au Canada.

 

Le genre masculin est utilisé sans discrimination et dans le seul but d'alléger le texte.

 


IDEAL PROFILE


Education

  • BA/BS required, preferably in Communications or related field with 3 years relevant experience 


Experience 

  • Minimum of 2 years of relevant work experience in the biotechnology, pharmaceutical or CRO or health/medical communication industry


Knowledge and skills

  • Knowledge of good clinical practice, ICH standards and applicable regulations
  • Good knowledge of European regulations/guidelines
  • English spoken and written, Spanish or French an asset
  • Experience in a research site environment an asset
  • Experience managing Patient advocacy group an asset
  • Experience in Patient recruitment strategies
  • Problem solving skills, good adaptability, versatile, and great attention to details
  • Strong organizational, communication, problem-solving and multi-tasking skills
  • Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.




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