Line Manager, Regulatory Documents Assistant

Description

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. 

He/she is also responsible for overseeing employee training and development to ensure optimal performance, and compliance with Innovaderm systems and processes.

More specifically, the Line Manager, RDA must:

• 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 ensures results and achieve targets.

• Review projects needs and provide recommendation for departmental resources needs and work assignations.

• 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.

• Participate in eTMF system implementation and upgrade activities (validation effort, change management, documentation of procedures, training).

• May perform TMF project tasks (QC, completeness verifications, quality reviews) as appropriate based on resourcing gaps, timelines, or training needs.

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;

• Respect established timelines, expectations, priorities, and objectives;

• Strong organizational and problem-solving skills.

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. 

In this position, you will be eligible for the following perks: 

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

Work location

Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.

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 India.