We are hiring

We are always looking for talented and dynamic people with unique and creative ideas who can actively contribute to the growth of our business.

What we have to offer

An exciting and dynamic business environment
The opportunity to take on a high level of responsibility
The freedom for personal and professional development

View openings in:

Job description

Type of Position: Full time/ Permanent

Department/Business Unit: Clinical Operations

Definition: The Associate Director of Clinical Operations (CRA) will manage a group of Clinical Research Associates and will coordinate their monitoring activities. She/he will assists the COO in overseeing the general management of the Clinical Operations department’s staff and services. Contributes to the ongoing improvement of the overall efficiency of the Clinical Operations department including interdepartmental relation. Collaborates cross-functionally with the Director, Clinical Operations to ensure client’s satisfaction.

Essential Functions: The following duties represent the principle job duties however they are not all inclusive:

  • Assists with developing and executing the departmental objectives
  • Collaborates with Business Development department in developing Service Agreement proposals and participates in bid defense presentations
  • Tracks staff resource utilization, assists with allocation of clinical study/project to appropriate staff and ensures adequate staff support of each clinical study/project
  • Attends Internal and Sponsor Kick-Off meetings
  • Assures that clinical studies/projects are conducted in compliance with Service Agreement (including deliverables and timelines), and applicable regulations and Standard Operating Procedures
  • Provides leadership to the site management team, project management, oversight to plan and conduct clinical studies/projects concurrently
  • Oversees planning, preparation and presentations at Investigator’s Meeting
  • Participates in the quality control processes Approves Project Plans, Monitoring Plans, CRA Quality Oversight Plans, Site Releases, IT Requests, Purchase Orders, and Vacation Requests
  • Provides support and direction to project team members, helps with problem resolution, and provides assistance and guidance to Project Managers and Clinical Research Associates.
  • Liaises with sponsor and site representatives, as required to ensure customer satisfaction
  • Ensures that clinical studies/projects status, change orders and team members’ time are tracked using the Project Management software
  • Liaise with other departments to ensure timely deliverables, as required
  • Contributes to the development of department and interdepartmental Standard Operating Procedures
  • Analyzes and recommends improvements to current systems and processes to ensure consistency and increase efficiency in the conduct of clinical studies/projects
  • Develops and/or implements tools to improve efficiency in the conduct of clinical studies/projects
  • Builds talent and capabilities of staff through proactive coaching, mentoring and development opportunities
  • Recruits employees to ensue department is staffed with qualified personnel
  • Coordinates and supervises staff providing constructive feedback
  • May also assure the management and lead the project team for one or more concurrent clinical studies/projects from initiation to closing as per Project Manager Job Description or Clinical Research Associate Description.

Skills and Qualifications:

Knowledge of:

  • CRO and Life Science Industries
  • Project management principles
  • Quality assurance principles
  • Business planning and financial budgeting
  • MS Office
  • ICH Guidelines
  • Good Clinical Practices
  • Good Documentation Practices
  • FDA 21 CFR Part 11 for handling of electronic records requirements

Ability to:

  • Maintain and exhibit discretion at all times when handling confidential information
  • Lead a multi-disciplinary project team
  • Make independent decisions and use good judgment
  • Plan, organize, and prioritize tasks efficiently
  • Communicate effectively orally and in writing
  • Assume multiple and concurrent tasks and responsibilities
  • Establish and maintain cooperative and effective working relations with fellow colleagues and employees
  • Communicate effectively with client, site and supplier representatives
  • Demonstrate integrity, respect, professionalism, commitment, accountability

Experience and Education:

  • M.Sc. in Life Sciences or equivalent B.Sc. with relevant work experience in clinical research
  • Relevant experience in CRO and/or biotech or pharma companies with monitoring background is a must.
  • Bilingual is a must

Job description

Definition: Under the direction of the COO, the Clinical Research Associate is responsible for monitoring clinical studies at investigational sites. Monitors those sites in order to ensure that studies are carried out according to protocol and in accordance with JSS SOPs, applicable regulations and the principles of Good Clinical Practice.

Essential Functions: The following duties represent the principal job duties however they are not all inclusive:

Familiarity with JSS Medical Research SOPs and appropriate regulations such as Health Canada

Independently or in consultation with the Sponsor/JSS/CRO, coordinate all the necessary activities required to setup and monitor a study

Conduct pre-study visit

Assess study site to ensure, facility, patient population and staff are sufficient to support the protocol.

Meet with PI and staff to review study requirements (protocol, CRFs, Sponsor policy and procedures, investigator responsibilities, staffing and patient recruitment)

Conduct study initiation visit

Confirm appropriateness of the IRB/ethics committee as per GCP

Train the site on the CRF completion, on the protocol and safety reporting procedure

Collect and forward all required study documentation to Sponsor or JSS.

Document visit and send a copy of the report to the site

Conduct routine monitoring visits

Review protocol compliance.

Verifies the source data and ensures that it is accurately reflected in the Case Report Form

Resolve questions by Investigator/Staff and ensures the validity of the queries sent to the site by the data management group

Check/inventory clinical supplies

Review communication with the IRB/ethics committee

Review study product accountability

Ensure that all consents (if applicable) are signed by the patient prior to study entry

Follow-up on previous issues

Collect all regulatory documents such as CV, MD licenses, IRB approvals etc…

Conduct close out visits to include:

Review and collect remaining CRFs.

Ensure that the Ethics committee has be advised of the termination of the study

Retrieve clinical supplies and any other study materials

Review investigator’s files to ensure that all documents are in order and ready for audit or inspection

Review retention policy and publication procedure

Review any follow-up requirements that may be required.

  • Keep the project manager informed

Skills and Qualifications:

Knowledge of:

  • Requirements of Good Documentation Practice
  • Applicable Regulatory Requirements pertaining to clinical research
  • FDA 21 CFR Part 11 for Handling of Electronic Records

Ability to:

  • Communicate effectively in spoken and written French (Quebec CRAs only) and English
  • Travel up to 80% of the time during peak study periods (international and domestic: fly and drive)
  • Maintain and exhibit discretion at all times when handling confidential information
  • Make independent decisions and use good judgment
  • Review and evaluate clinical data
  • Plan, organize, and prioritize tasks efficiently
  • Communicate effectively orally and in writing
  • Assume multiple and concurrent tasks and responsibilities
  • Establish and maintain cooperative and effective working relations with sites
  • Demonstrate behaviors that are shared at JSS Medical Research: integrity, respect, professionalism, commitment, accountability

Experience and Education:

  • Must have a minimum of a B.Sc. degree.
  • Minimum of two years previous field monitoring experience

Job description

Relève de : Directeur des finances – Montréal

Rôle principal : Responsable de la comptabilité de Management et de la gestion budgétaire pour ses clients internes toujours en ayant l'ambition d'améliorer ses pratiques et les processus de travail dans un contexte de forte croissance. Nous créons donc la Position d’Analyste Financier pour nos Projets de Recherche Clinique.

Responsabilités principales :

Comptabilité de Management
  • Produire des rapports de suivis des couts pour la direction et les clients.
  • Participer aux réunions des Opérations Cliniques afin de s'assurer du suivi financier de chaque projet.
  • Effectuer les calculs d’allocation par projet pour allouer les amortissements et s’assurer que les frais généraux sont répartis.
  • Faire la reconnaissance de Revenu et tenir à jour les revenus prévisionnels en fonction des changements dans les projets.
  • Produire des rapports de gestion pour l'équipe de direction.
  • Assurer la bonne gestion du fond de roulement de chaque projet.
  • Valider les rapports de production sur une base hebdomadaire.
  • Tenir à jour et bien organiser tous les dossiers de projet.
  • Préparer et faire les ajustements nécessaires suite à des modifications de contrat telles que demandées par les Clients, les Opérations Cliniques ou le service finance.
  • Produire des analyses spéciales requises par les clients externes.
  • Produire et vérifier tout rapport financier requis par les Opérations Cliniques.

Gestion des budgets

  • Collaborer avec les Gestionnaires de Projets et le "Développement des Affaires" relativement aux nouvelles opportunités d'affaires.
  • Assurer la gestion budgétaire des projets en cours, incluant la communication avec les équipes de recherches cliniques ainsi qu'avec les clients externes.

Projets Mondiaux

  • Assurer la communication avec les services des Finances de nos filiales étrangères (USA, Inde, Colombie et Pologne) afin de valider la profitabilité des Projets qui sont effectués à travers le Monde plutôt que localement.

Crédit Impôt Recherche et Développement Scientifique

  • Participer très activement à la préparation des demandes de crédits d'impôt pour Recherche et Développement Scientifique.
  • Organiser et gérer les différents audits ou activités de vérification ainsi que préparer des demandes d’information des autorités fiscales.

Optimisation des outils et des processus

  • Assurer l'efficience du système d'administration des projets (dossiers dument organisés et classés en vue de la vérification de fin d'année).
  • Faire les recommandations appropriées pour améliorer la production des rapports, les processus de contrôle interne, etc.
  • Améliorer l'utilisation et l'efficience des systèmes d’informations et de gestion.
  • Support à son équipe et autres collègues puis participation à certains projets spéciaux selon les besoins

Exigences et compétences requises :

Expérience et formation

  • Formation universitaire de premier cycle en comptabilité ou l'équivalent Expérience confirmée dans un poste d’Analyste Financier
  • Expérience dans le domaine de la Recherche, un atout
  • Maîtrise de la suite Office et plus particulièrement d'Excel (programmation, Macros, VBA)
  • Connaissance du système comptable Acomba, un atout
  • Connaissance du système de gestion des essais clinique Flex Databases, un atout.
  • Bilinguisme (français et anglais) un atout important
  • Espagnol un atout certain pour la Communication avec notre filiale Colombienne

Qualités et aptitudes

  • Excellente aptitude à la communication, sens aigu du service à la clientèle et esprit d'équipe
  • Capacité de gérer plusieurs dossiers simultanément ainsi que de prioriser et de respecter les échéances
  • Organisé(e), méthodique et forte attention aux détails
  • Proactif(ve) et créatif(ve) dans l'apport de solutions d'optimisation des outils et processus existants
  • Sens des responsabilités, fiable et digne de confiance

Conditions de travail :

  • Poste permanent à temps plein 35h par semaine
  • Semaine générale de travail de 5 jours, du lundi au vendredi (une certaine flexibilité est nécessaire)
  • Des déplacements d'affaires à l'extérieur du pays pourraient être à prévoir
  • Assurances collectives complètes
The are no open positions at this time.
The are no open positions at this time.
The are no open positions at this time.

Our Location

9400 Henri-Bourassa Blvd. West St-Laurent (Montreal) Quebec H4S 1N8

+1 514-934-6116