The CRA Line Manager, Clinical Monitoring, is responsible for the day to day management of an assigned team of both permanent staff (CRAs) and contract Clinical Research Associates (cCRAs), overseeing their performance and training, ensuring adequate monitoring resources, assistance with allocating resources to projects, identifying quality issues related to clinical monitoring 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 contract CRAs.
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 the CRAs within their specified team. Implements professional development and performance evaluations;
Supports the training and development of clinical monitoring personnel within their remit and ensures team members’ consistent use of study tools and training materials;
Tracks clinical monitoring 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 on-site Accompanied Site Visits with CRAs;
Identifies quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, Accompanied Site Visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;
Serves as a point of contact for CRAs and other team members for assigned projects or initiatives;
Assists with assessing and interviewing potential clinical monitoring candidates;
May conduct on-site 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 monitoring plans;
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 monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.
B.Sc. in a field relevant to clinical research.
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. Knowledge of French an asset;
Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
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.
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;
Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities);