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Manager, eTMF Operations


The Manager, eTMF Operations oversees activities of the global eTMF Operations team (Regulatory Document Assistants, Senior Regulatory Document Assistants). The Manager, eTMF Operations also works with departmental functional leads and assumes a key role on supporting inspection readiness as a culture and compliance with GCP regulatory requirements.

 

 

RESPONSABILITIES

 

More specifically, the Manager, eTMF Operations:

 

  • Determines resource requirements, and interviews, hires and trains new employees as required.
  • Oversees the performance of direct reports and performs annual reviews, addresses employee relation issues, and escalates issues.
  • Ensures the eTMF activities are delivered on time, within budget, and in compliance to SOPs and regulations.
  • Oversees study assignments for start-up, maintenance, and close-out activities in regard to the TMF. Ensures complete, contemporaneous, and accurate eTMF across all studies and programs. Supports start-up activities (eTMF deployment, study specific TMF Plan, project kick-off meetings).
  • Identifies TMF trending issues/concerns and determines resolutions and course of actions.
  • Serves as subject matter expert (SME) to develop and mentor the team.
  • Provides support and guidance to drive performance against TMF KPIs (completeness, quality and timeliness) using reports and metrics
  • Performs TMF project tasks (QC, completeness verifications, quality reviews) as appropriate based on resourcing gaps, timelines, or training needs.
  • Assists with the oversight of eTMF system vendor (contracts, invoicing, governance meetings). Communicates with vendor for system development, improvement, and maintenance.
  • Identifies and leads improvement initiatives on processes and systems to enhance TMF operational efficiencies with a focus on inspection readiness.
  • Oversees development of departmental SOPs and Working Instructions.
  • Participates in validation effort of new functionalities and patch/upgrade release of the eTMF platform.
  • Participates in sponsor audits and regulatory agency inspections.

PROFILE

 

Education

 

  • Bachelor degree in life sciences;

 

Experience

 

  • At least 5 years of experience in the pharmaceutical, biotechnology and/or CRO industry;
  • Experience in document management/TMF and thorough knowledge of TMF governing regulations
  • Experience working with eTMF technologies such as Transperfect Trial Interactive or Veeva Vault
  • Functional staff management experience preferred;

 

Skills and knowledge

 

  • Working familiarity with the TMF Reference Model
  • Understanding of the processes associated with the conduct of clinical trials and document management operations.
  • Excellent communication skills;
  • Ability to organize own work, prioritize different assignments, and work under pressure;
  • Attention to detail and accuracy in work;
  • Versatile and comfortable in a multitasking environment;
  • Respect established timelines, expectations, priorities, and objectives;
  • Excellent knowledge of Microsoft Office suite;

 

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) 
  • 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. 

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