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.

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.
• Collaborates with Managers and Directors of CRO departments to ensure TMF documentation is submitted in a timely manner. 
• Develops improvements initiatives to increase compliance and follows up on non-compliance, if applicable.

REQUIREMENTS

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

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. 

When joining Innovaderm, you will be eligible for the following perks: 

• Flexible work schedule
• Permanent full-time position
• various benefits
• 100% remote role
• Ongoing learning and development

Innovaderm is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, gender, gender identity or expression, sex, genetic information, marital status, national origin, race, religion, protected veteran status, sexual orientation, citizenship status, individuals with disabilities or other characteristics protected by law. 

Innovaderm only accepts applicants who can legally work in Poland.