Line Manager, Regulatory Document Assistants (RDA) - Remote

Overview

The Line Manager, RDA is responsible for line management of employees in the eTMF Operations group, including but not limited to the hiring and supervision of Senior Regulatory Documents Assistants (Sr RDAs) and Regulatory Documents Assistants (RDAs), ensuring availability of appropriate resources to meet company and project objectives, and ensuring alignment across the various project teams.

In Short

• Manage and develop Senior RDAs and RDAs to ensure high quality work performance and retention of high-quality employees.
• Oversee the day-to-day activities, manage performance, conduct formal performance reviews and talent conversation meetings, and approve timesheets of direct reports.
• Promote a positive work environment and motivate the team to achieve organizational goals.
• Ensure adequate support, coaching, and mentoring of their employees for coordination of work.
• Develop and implement strategies to ensure results and achieve targets.
• Review project needs and provide recommendations for departmental resources needs and work assignments.
• Participate in the hiring process of new employees and lead new-hire orientation and training.
• Provide leadership and implement productivity improvements to ensure optimal utilization of resources and participate in process improvement initiatives.
• Design and deliver relevant training to the group.
• Participate in the writing, review, and update of related SOPs, TOOLs, and work instructions.

Requirements

• College degree.
• At least 3 years of relevant experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry, including experience in eTMF roles.
• Proficiency in written and oral English.
• Experience working with TMF Reference Model and eTMF technologies, such as Transperfect Trial Interactive or Veeva Vault.
• Knowledge of clinical trial operations, ICH/GCP Guidelines, and other applicable regulatory requirements.
• Experience managing functional staff is considered an asset, and the ability to develop skills of others and motivate team members.
• Computer skills including proficiency in the use of Microsoft Word and Excel.
• Ability to organize own work and prioritize different assignments.
• Attention to detail and accuracy in work.
• Strong organizational and problem-solving skills.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Ongoing learning and development.