Manager, Clinical Quality Control Department

CareAbout•Montreal, QC

14d•Hybrid

About The Position

The Manager, Clinical Quality Control Department is responsible for the management of the Quality Systems team, ensuring the quality of clinical trial data and the efficiency and completion of quality related tasks. The Manager, Clinical Quality Control Department will ensure tasks performed are conducted within compliance of study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).

Requirements

College or University Degree completed
Minimum of 3 years of experience in the clinical research field
3 to 5 plus years related experience in management of a team
Microsoft suite
Strong computer literacy
Ability to read and interpret technical documents and industry specific manuals.
Ability to write advanced reports and correspondence.
Bilingual proficiency in English/French
Excellent verbal and written communication skills.
Well-developed interpersonal skills are required.
Personal/professional integrity and proven discretion in handling confidential information.
Ability to develop strong trusting relationships in order to gain support and achieve results.
Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.
Customer service focused.
Able to work in fast-paced environment with conflicting priorities.
Fluency in English is an essential requirement for the position of Clinical Quality Control Associate including, but not limited to, for the following reasons: The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.

Responsibilities

Management of the Quality Systems team, including but not limited to, PTO management, timesheet approval, on-going and yearly performance reviews, employee hiring, disciplinary actions and termination.
Perform, direct and/or oversee the training of the Quality Systems team.
Proactively assess learning opportunities for the Quality Systems team.
Ensure the confidentiality of clinical trial participants and sponsors is respected.
Maintain and advocate a high level of quality and customer service within the department.
Participate in sponsor/regulatory audits, respond to and/or complete pre-site audit questionnaires and audit reports.
Review quality inputs/deviations, track trends and evaluate the QC process and risk mitigation; escalate as required.
Implement quality initiatives and process improvements within the department.
Monitor clinical trial timelines to ensure clinical trial data milestones are met related to data entry, query tracking and resolution, and deviation management.
Participate in SOP revisions.
Perform and/or ensure the training on external databases.
Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
Hold meetings to communicate clinical trial needs and/or departmental objectives.