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

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.
• 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.

IDEAL PROFILE 

Education  

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

Experience  

• 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.
• Experience in a CRO is an asset.

Knowledge and skills 

• Excellent oral and written English 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.

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
• Vacation, PPK, health allowance
• Home-based position with teleworking allowance
• 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 Poland.