Clinical Operations Manager, North America

The Clinical Operations Manager is responsible for the day-to-day management of an assigned team of both permanent and contracted staff (e.g., Clinical Research Associates (CRA)/(cCRA)), Clinical Operations Support personnel, etc.) overseeing their performance and training, ensuring adequate monitoring and support team resources, assistance with allocating resources to projects, identifying quality issues related to clinical operations activities and establishing action plans to address them. **

This role will be perfect for you if** :

• Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you
• You enjoy working for a mid-sized CRO where your contributions are noticed and valued
• You enjoy managing the day to day of CRAs and contractual CRAs

Responsibilities

More specifically, the Clinical Operations Manager must:

• Ensures that clinical monitoring activities of their assigned team are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements
• Oversees the performance of their direct reports. Implements professional development and performance evaluations
• Supports the training and development of Clinical Operations personnel within their remit and ensures team members’ consistent use of study tools and training materials
• Tracks Clinical Operations metrics such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings
• Performs Accompanied Site Visits (e.g., Quality Assessment Visit - QAV) with CRAs. Identifies quality issues related to Clinical Operations activities through project meetings, site communications, site visit reports and follow-up letters, QAVs, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions. Serves as a point of contact for Clinical Operations personnel and other team members for assigned projects or initiatives
• Assists with assessing and interviewing potential Clinical Operations candidates
• May conduct on-site or remote monitoring visits to offer support to project teams
• May perform site visit report review and track site visit report metrics to ensure compliance
• May review or provide input to Clinical Operations Plans and Tools
• May review and provide feedback on related SOPs and Tools during updates
• Serves as a management contact for sites, project teams, and sponsors when issues related to clinical operations and trial management activities must be escalated to ensure communication is maintained and resolution is achieved
• Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Requirements: **

Education**

• B.Sc. in a field relevant to clinical research

Experience

• Experience in a CRO moreover, in dermatology are assets
• Minimum of 6 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, including a minimum of 3 years of clinical monitoring, and a combined 3 years of managing CRAs in a similar role or 3 years acting in a Lead CRA or Clinical Trial Manager role

Knowledge And Skills

• Excellent mastery of Microsoft Office suite (Word, Excel, Power Point)
• Ability to work in a fast-paced evolving environment and establish good relationships with colleagues and sponsors
• Quick learner, good adaptability and versatile
• Excellent leadership, judgement, and problem-solving skills
• Strong organizational, communication, time management and multi-tasking skills
• Travel up to 20% of the time
• Good knowledge of good clinical practices, applicable Health Canada, Food and Drug Administration (FDA), European Medicines Agency (EMA) regulations/guidelines and other applicable regulatory requirements

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. **

Work location**

Note that this opening is for a home-based position in the US and/or Canada.

Regular travel, which may include overnight trips, is required as part of this role. International travel may be required occasionally. **

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 North America.