Clinical Document Specialist – Phase I to IV
About the role
Clinical Document Specialist – Phase I to IV Position open only to Canadian citizen\resident or with Canadian work permit Full Time
Seriant, a division of the Montreal Heart Institute, is a clinical research organization that provides comprehensive services to the pharmaceutical and biotechnology industries, as well as to the academic community. Based in Montreal, we operate internationally, covering all phases of clinical trials across a wide range of therapeutic areas. With our proven expertise in developing innovative therapies, we make a meaningful impact on people’s lives around the world.
We believe that great minds change the world. We’re looking for passionate individuals to help manage and support clinical studies that improve healthcare and create lasting impact. Just as we transform lives through research, we enrich the lives of our employees with benefits that truly make a difference. Your contribution matters, your growth is valued, and your impact is real. Join us and put your skills in the spotlight.
RESPONSIBILITIES
• Assists the TMF system administrator in managing user access, setting up, maintaining and monitoring filed study documents; • Files documents in designated sections of the TMF, ensuring it is audit and inspection-ready; • Participates in the quality control of documents (paper and/or electronic) submitted to the TMF; • Conducts quality checks of the TMF in accordance with the TMF Project Plan to ensure accuracy, consistency, and quality of documents; • Collaborates closely with cross-functional teams to ensure timely submission and retrieval of critical documents; • Identifies risks related to TMF and ensures compliance with internal and regulatory requirements; • Manages the resolution of issues related to the TMF and acts as a point of contact for team questions; • Collaborates with team members to correct filing errors or missing documents; • Assists in the transfer of the final TMF to designated parties; • Educates and supports Team members on TMF responsibilities and mistakes to avoid; • Oversees the proactive management of clinical documentation, ensuring that all documentation is up-to-date, compliant and easily accessible; • Participates in the improvement of the TMF's management processes, including development and update of SOPs, guidelines and training materials, as required; • Collaborates with the study team to implement QC initiatives for TMF-related activities; • Participates in the preparation and conduct of regulatory inspections and audits with respect to clinical documentation and TMF; • Provides progress reports, tracking, and performance metrics (client meetings, presentations); • Maintains effective communication with internal and external stakeholders; • Provides TMF training and support to study team members; • Performs other duties as assigned by the Clinical Monitoring and Support Manager.
REQUIREMENTS
• Bachelor of Science, Administration or equivalent (mandatory); • Perfectly bilingual, spoken and written French/English (mandatory, tests to be passed); • Advanced proficiency in MS Office (Word, Excel, and PowerPoint) – Candidates must pass tests in Word and Excel. • Minimum of one (1) year of experience in clinical research and a minimum of two (2) years of experience in clinical documentation management and archiving in a pharmaceutical/biotechnology setting or in a contract research organization; • High level of attention to detail; • Excellent analytical and problem-solving skills; • Ability to effectively set priorities; • Strong organizational, interpersonal and teamwork skills; • Ability to initiate assigned tasks and work independently.
WORK CONDITIONS
• 35 hours weekly base • Pre-approved overtime paid • Flexible work schedule for work-family balance • Hybrid model (working from home and office) • 4 weeks’ vacation after one year • 13 statutory holidays • Defined retirement benefits • Group insurance • 9.6 day off sick days
We offer a wide range of benefits aimed at the health, well-being, and quality of work life of employees, including free access to the EPIC Center, as well as various other benefits.
TO SUBMIT YOUR APPLICATION :
• Please visit our career page : https://atlas.workland.com/careers/icm-mhi/about
We subscribe to an equal access program. Applications from targeted groups (women, visible minorities, ethnic minorities, Indigenous peoples, and persons with disabilities) are encouraged
We thank all those who apply to this position but only candidates that have been selected for an interview will be contacted.
Visit our web site: www.seriant.org
About Institut de Cardiologie de Montréal
Centre hospitalier ultraspécialisé en cardiologie, l'Institut de Cardiologie de Montréal est voué aux soins, à la recherche, à l'enseignement, à la prévention, à la réadaptation, ainsi qu'à l'évaluation des nouvelles technologies en cardiologie. Constamment à l'avant-garde, l'ICM est un leader dans son domaine et joue un rôle de premier plan au Québec, au Canada et dans le monde. Il est affilié à l'Université de Montréal.
Clinical Document Specialist – Phase I to IV
About the role
Clinical Document Specialist – Phase I to IV Position open only to Canadian citizen\resident or with Canadian work permit Full Time
Seriant, a division of the Montreal Heart Institute, is a clinical research organization that provides comprehensive services to the pharmaceutical and biotechnology industries, as well as to the academic community. Based in Montreal, we operate internationally, covering all phases of clinical trials across a wide range of therapeutic areas. With our proven expertise in developing innovative therapies, we make a meaningful impact on people’s lives around the world.
We believe that great minds change the world. We’re looking for passionate individuals to help manage and support clinical studies that improve healthcare and create lasting impact. Just as we transform lives through research, we enrich the lives of our employees with benefits that truly make a difference. Your contribution matters, your growth is valued, and your impact is real. Join us and put your skills in the spotlight.
RESPONSIBILITIES
• Assists the TMF system administrator in managing user access, setting up, maintaining and monitoring filed study documents; • Files documents in designated sections of the TMF, ensuring it is audit and inspection-ready; • Participates in the quality control of documents (paper and/or electronic) submitted to the TMF; • Conducts quality checks of the TMF in accordance with the TMF Project Plan to ensure accuracy, consistency, and quality of documents; • Collaborates closely with cross-functional teams to ensure timely submission and retrieval of critical documents; • Identifies risks related to TMF and ensures compliance with internal and regulatory requirements; • Manages the resolution of issues related to the TMF and acts as a point of contact for team questions; • Collaborates with team members to correct filing errors or missing documents; • Assists in the transfer of the final TMF to designated parties; • Educates and supports Team members on TMF responsibilities and mistakes to avoid; • Oversees the proactive management of clinical documentation, ensuring that all documentation is up-to-date, compliant and easily accessible; • Participates in the improvement of the TMF's management processes, including development and update of SOPs, guidelines and training materials, as required; • Collaborates with the study team to implement QC initiatives for TMF-related activities; • Participates in the preparation and conduct of regulatory inspections and audits with respect to clinical documentation and TMF; • Provides progress reports, tracking, and performance metrics (client meetings, presentations); • Maintains effective communication with internal and external stakeholders; • Provides TMF training and support to study team members; • Performs other duties as assigned by the Clinical Monitoring and Support Manager.
REQUIREMENTS
• Bachelor of Science, Administration or equivalent (mandatory); • Perfectly bilingual, spoken and written French/English (mandatory, tests to be passed); • Advanced proficiency in MS Office (Word, Excel, and PowerPoint) – Candidates must pass tests in Word and Excel. • Minimum of one (1) year of experience in clinical research and a minimum of two (2) years of experience in clinical documentation management and archiving in a pharmaceutical/biotechnology setting or in a contract research organization; • High level of attention to detail; • Excellent analytical and problem-solving skills; • Ability to effectively set priorities; • Strong organizational, interpersonal and teamwork skills; • Ability to initiate assigned tasks and work independently.
WORK CONDITIONS
• 35 hours weekly base • Pre-approved overtime paid • Flexible work schedule for work-family balance • Hybrid model (working from home and office) • 4 weeks’ vacation after one year • 13 statutory holidays • Defined retirement benefits • Group insurance • 9.6 day off sick days
We offer a wide range of benefits aimed at the health, well-being, and quality of work life of employees, including free access to the EPIC Center, as well as various other benefits.
TO SUBMIT YOUR APPLICATION :
• Please visit our career page : https://atlas.workland.com/careers/icm-mhi/about
We subscribe to an equal access program. Applications from targeted groups (women, visible minorities, ethnic minorities, Indigenous peoples, and persons with disabilities) are encouraged
We thank all those who apply to this position but only candidates that have been selected for an interview will be contacted.
Visit our web site: www.seriant.org
About Institut de Cardiologie de Montréal
Centre hospitalier ultraspécialisé en cardiologie, l'Institut de Cardiologie de Montréal est voué aux soins, à la recherche, à l'enseignement, à la prévention, à la réadaptation, ainsi qu'à l'évaluation des nouvelles technologies en cardiologie. Constamment à l'avant-garde, l'ICM est un leader dans son domaine et joue un rôle de premier plan au Québec, au Canada et dans le monde. Il est affilié à l'Université de Montréal.