eTMF System Specialist


The eTMF System Specialist works closely with operational teams to optimize the utilization of the electronic Trial Master File (eTMF).

As eTMF System Specialist, the person will be responsible for overall management and quality maintenance of the eTMF, with a strong focus on ensuring that eTMF operations are performed in accordance with SOPs and ICH/GCP/TMF guidelines.

 

Responsibilities

  • Manage and support the electronic Trial Master File (eTMF), including system set-up, maintenance, support, testing, and documentation.
  • Research, interpret, explain and apply information from computer system technical manuals and guides, videos and online materials.
  • Develop an in-depth understanding of operational workflows in order to develop and implement system processes.
  • Analyzes internal customers’ needs and determines system requirements/ad-hoc reports.
  • Communicate with vendor for system support, development, improvement, and maintenance; work with vendor to understand new version functionality and patch releases,
  • Prepare, execute, and document all aspects of Validation Testing for the system in collaboration with the Computerized System Validation Manager.
  • Participates in team initiatives to develop practices, processes, and tools for the set-up and maintenance of eTMF.
  • Provides subject matter expertise to project teams and functional departments.
  • Participates in the development of the eTMF Management Plan.
  • Develops the study configuration specifications (Index/Milestones/Required documents).
  • Performs record review of essential documents within required timelines for accuracy and quality in the eTMF.
  • Is responsible for resolution of internal quality control findings or external compliance audit findings from sponsors.
  • Leads internal meetings to review outstanding queries.
  • Attends project meetings to support RDA project deliverables.
  • Sets up the conduct of eTMF quality reviews and addresses quality review findings.
  • Provides feedback to project teams on eTMF project performance metrics.
  • Monitors and identifies TMF trends and escalates concerns to management
  • Leads study closeout activities of the eTMF with functional departments.

 

Profile

Experience

  • 2-5 years of relevant experience, in clinical research in the biotechnology, pharmaceutical, and/or CRO industry;
  • Experience in the development and maintenance of Sponsor eTMF (eg, Trial Interactive, Veeva)

Skills

  • Knowledge of clinical trial operations, ICH /GCP Guidelines and other applicable regulatory requirements;
  • Bilingual French and English;
  • Ability to organize own work and prioritize different assignments;
  • Attention to detail and accuracy in work;
  • Respect established timelines, expectations, priorities, and objectives;
  • Versatile and comfortable in a multitasking environment;
  • Interpersonal and leadership skills;
  • Experience in people management, an asset.

 

OUR COMPANY

The work environment

At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.

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);
  • Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station);
  • 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. 

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