Clinical Data Coordinator

6 days ago

Montreal, Quebec, Canada Innovaderm Research Full time

The Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Innovaderm, are collected, managed and reported clearly, accurately and securely.

In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm's commitment to sponsor's requirements and timelines.


This role will be perfect for you if:

  • You have strong analytical capacities and an ease to work with data.
  • You enjoy working with systems and technology, continuously learning.
  • You want to work in a collaborative team where your ideas are heard and valued.

RESPONSIBILITIES

  • Provides general data management support to the project team, sponsor and external vendors, as needed.
  • Supports Lead Data Manager in the areas of:
  • Data Review.
  • Data Reconciliation.
  • Discrepancy Management.
  • Maintenance of Study Metrics; Monitoring study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.
  • Generation of Ad-Hoc Study Reports.
  • User Maintenance.
  • Assisting with User Acceptance Testing.
  • Assisting with designing of database.
  • Assisting with creating data management plan (DMP), and other clinical data management related documentation.
  • Assisting in ensuring that data management documentation is complete and uptodate in the trial master file (TMF).

Requirements:

IDEAL PROFILE

Education

  • B.Sc. or related field;

Experience

  • Minimum of 1 year of clinical data management experience in the pharmaceutical industry or in a CRO environment;
  • Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset.

Knowledge and skills

  • A general knowledge of CDASH/SDTM is considered an asset
  • Highly organized and detailoriented with effective project planning and time management skills;
  • Strong verbal and written communication skills in English, French is an asset;
  • Ability to work in a fastpaced environment with demonstrated agility to juggle and prioritize multiple competing demands;
  • Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment.
  • Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

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 fulltime position
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
  • 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 coordonnateur des données cliniques participera à diverses activités de gestion des données cliniques requises pour s'assurer que les données recueillies dans le cadre des essais cliniques entrepris ou gérés par Innovaderm sont recueillies, gérées et rapportées de façon claire, précise et sécurisée.

De plus, il est requis pour ce poste de mener toutes ces activités conformément aux exigences réglementaires applicables, aux lignes directrices de l'industrie et aux procédures d'exploitation normalisées (SOP) d'Innovaderm tout en respectant l'engagement d'Innovaderm envers les exigences et les échéanciers du client.


Ce poste sera parfait pour vous si:

  • Vous avez de fortes capacités d'analyse et une facilité à travailler avec des données.
  • Vous aimez travailler avec des systèmes informatiques et apprendre de façon continue.
  • Vous souhaitez travailler dans une équipe collaborative ou vos idées sont écoutées et valorisées.

RESPONSABILITÉS

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