Our client, a medical diagnostics company working on cutting edge technology, are looking for a Clinical Operations Manager to join their team in Montreal, Quebec. Reporting to the Senior Director of Medical Affairs, the Clinical Operations Manager is responsible for the preparation and execution of clinical studies in a timely and compliant manner. General areas of responsibility include project assessment and initiation, technical support and training for investigational devices, development and training on clinical tools and data management needs, milestone planning and tracking, and ensuring that projects are progressing according to quality standards, Standard Operating Procedures (SOPs), International Conference on Harmonisation (ICH), and/or other guidelines to fulfill local regulations.
- Develop and implement Standard Operating Procedures (SOPs) for clinical study planning, conduct, patient safety, and data quality that meets ICH-GCP guidelines.
- Oversee and resolve operational aspects of clinical trials in accordance with standard operating procedures (SOPs) and specific country regulations.
- Support clinical study initiation, execution, and close out activities, including device installation and testing, training and qualification of device operators, and management of routine/minor device maintenance for optimal operation.
- Serve as a technical resource to ensure consistency of clinical study processes and data collection across clinical trials.
- Develop and implement study tools/databases and training materials that comply with standard processes, policies and procedures.
- Author or perform quality control review of data management documents, such Data Management Plans (DMP) and Data Transfer Plans.
- Programming of API, edit checks, and other system functions within EDC as needed.
- Review eCRFs and facilitate or participate in User Acceptance Testing (UAT) prior to study go-live.
- Perform study-specific data management tasks including the creation of internal data file specifications as needed, and preparation / review of data to ensure data quality and integrity prior to analysis.
- Monitor and report progress of clinical studies, assess key performance metrics, and follow up with team members and study personnel when issues develop.
- Oversee or participate in Database Lock activities, including managing user access and authoring or providing quality control review of lock documentation.
- Manage risks (positive and negative) which could impact on the clinical delivery of the project and determine contingencies. Partner with study personnel in problem solving and resolution efforts.
- Identify and communicate lessons learned and implement best practices to promote continuous improvement.
- Travel to aid in program facilitation.
- Other duties as required.
- The candidate should have a Bachelor’s degree in a relevant field, with at least 5 years of experience in a healthcare related field (CNS and/or medical device/diagnostic is of particular interest).
- Technical degree (engineering or IT) and/or demonstrate technical skills to support device installation and routine maintenance is an advantage.
- Familiarity with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
- The position requires working knowledge of data file formats, file transfer methods, testing file export programs, documentation requirements and quality assurance requirements for clinical studies.
- Requires well-developed human relations skills to convey technical concepts and consult with a range of internal contacts and external clients/customers for purposes of generating, testing and transferring data files and problem solving.
- Requires good organizational, time management, and problem-solving skills.
- Ability to be flexible and take direction, as well as to work independently and in a team environment.
- Must be detail-oriented, motivated to work in a fast-paced environment, and able to effectively handle confidential matters.
- Ability to manage multiple tasks, establish priorities, and meet tight deadlines.
For additional details, please contact Cynthia McCutcheon at Summit Search Group directly: [email protected]
Please note that only those candidates who fulfill the requirements will receive a response.
Summit Search Group is a fair and equitable search firm. We welcome and encourage applications from all candidates regardless of ethnicity, race, religious beliefs, disability, age, gender identity, or sexual orientation. Accommodations are available on request for candidates taking part in all aspects of the recruitment and selection process.