Senior Regulatory Documents Assistant


The Senior Regulatory Documents Assistant (RDA) 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. The Sr RDA will establish and maintain the Sponsor electronic Trial Master File (eTMF) throughout the life of the trial, and will perform record review of essential documents.

The Senior RDA will work in collaboration with the Manager to harmonize and improve TMF operations processes.

 

This role will be perfect for you if:

 

  • You enjoy working with a collaborative team
  • You have eTMF experience and are looking for a role where you can continue developing your leadership

 

RESPONSIBILITIES

 

  • Participates in team initiatives to develop practices, processes, and tools for the set-up and maintenance of eTMF.
  • Acts as a mentor to new and junior staff, helps in assigning work, and provides coaching/training.
  • 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.
  • Prepares the Investigator’s Study Files (ISF) and ships the binders to investigative sites.

IDEAL PROFILE

 

 

Education 

  • College degree

 

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 TMF

 

Knowledge and 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 collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

As a Senior Regulatory Documents Assistant, you will be eligible for the following perks: 

  • Flexible work schedule
  • 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)
  • Possibility of working from home in accordance with company policies and public health directives
  • 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. 

All Available Positions


Position Department Location
Biostatistician CRO - Data Management and Statistics Canada
Clinical Trial Manager CRO - Clinical Monitoring Poland
Clinical Data Coordinator CRO - Data Management and Statistics Montreal, Canada
Site Selection Coordinator CRO - Study Start up Montreal, Canada
Associate Project Manager CRO - Project Management Montreal, Canada
Accounting Clerk Corporate - Finance and Accounting Montreal, Canada
Team Lead eTMF Operations CRO - Regulatory and Scientific Affairs Montreal, Canada
eTMF System Specialist CRO - Regulatory and Scientific Affairs Montreal, Canada
Clinical Scientist CRO - Scientific and Regulatory Affairs Canada
Site Selection Specialist (Clinical Research) CRO - Study start up Montreal, Canada
Senior Regulatory Documents Assistant CRO - Regulatory and Scientific Affairs Montreal, Canada
Project Coordinator (clinical research) CRO - Project Management Montreal, Canada
Senior Project Manager CRO - Project Management Canada
Regulatory Affairs Coordinator CRO - Regulatory and Scientific Affairs Montreal, Canada
Future opportunities General Montreal, Canada