Medical Monitor – Magazica Career Hub

Title: Medical Monitor

Company: Seriant (formerly MHICC)
Location: Montreal, Quebec
Job Type: FlexTime, FullTime, Holidays

Description:

Position open only to Canadian citizens or residents, or those with a Canadian work permit, the Medical Monitor, Clinical Research role at Seriant, a division of the Montreal Heart Institute, involves providing medical expertise for clinical studies. Responsibilities include evaluating the safety and efficacy of investigational products, ensuring consistency in data recorded, and creating/editing regulatory documents while adhering to SOPs and GCP.

If you can adapt to urgent demands, balance regulatory requirements with operational realities, and have a strong intellectual curiosity, this role may be a good fit for you.

Responsibilities:

Develop safety documents and templates

Assist with developing clinical study protocols and reports

Review case report forms and provide input

Generate various safety and risk management plans

Identify and escalate project issues

Provide guidance to site staff on data collection

Ensure medical consistency and validity of data

Contribute to regulatory submissions

Build relationships with sponsors and vendors

Participate in process improvement

Requirements:

Medical degree or Doctor of Medicine

Bilingual in French and English

Minimum 3 years of experience in life sciences

Experience in cardiovascular clinical research

Strong analytical and problem-solving skills

Knowledge of clinical research methodology and regulations

Proficiency in Microsoft Office and other relevant software

Work Conditions:

35-hour workweek, pre-approved overtime, flexible schedule, hybrid work model, vacation, holidays, retirement benefits, group insurance, sick days, and access to the EPIC Center.

To Submit Your Application:

Deadline: Open until filled. Send cover letter and resume to rh@seriant.org. Equal access program. Encourages applications from targeted groups. Only selected candidates will be contacted.

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Title: Medical Monitor
Company: Seriant (formerly MHICC)
Location: Montreal, Quebec
Medical Monitor, Clinical Research  Phase I to IV Position open only to Canadian citizenresident 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. ABOUT THE ROLE The incumbent in this ro l e is responsible for providing medical expertise for clinical studies by evaluating, assessing the safety and efficacy of investigational products via the safety management plan; ensuring consistency, comp l eteness and medical coherence between all Adverse Events (A E s) / Clin i cal endpoints and other data recorded in the Case Report Form (CRF). The person is also accountable for researching, creating and editing regulatory documents (e.g. Narratives, Safety Annual Reports), while ensuring compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and other applicable regulatory requirements . THIS ROLE WILL BE AN EXCELLENT MATCH FOR YOU IF: · You can effectively adapt to urgent, timesensitive work demands and manage multiple responsibilities, maintaining a quality and compliancefocused approach · You consistently balance strict regulatory and protocoldriven requirements with the operational realities of clinical trial conduct · You are driven by strong intellectual curiosity and consistently apply this mindset to ensure thorough understanding of regulatory requirements, and highquality, compliant work RESPONSIBILITIES · Develops safety documents using appropriate and approved templates, create new templates adhering to Seriant Standard Operating Procedures (SOPs) and industry guidelines · Provides assistance to the Medical Writer in developing and/or reviewing clinical study protocols and clinical study reports · Develops, revises, implements, and provides training on the standard operating procedures · Reviews case report forms and other related documents, and provide input on their design for optimal and precise data capture · Generates the DSMB and CEC charters and followsup to ensure committee composition has been completed · Generates the Safety Management Plan (SMP), the Risk Management Plan (RMP), the Signal Management Report (SMR), and all other relevant documents according to the protocol and regulatory requirements to ensure medical safety for clinical trials and postmarketing studies · Identifies and escalates to the management team all issues that could affect project quality and timelines and provides realistic and applicable solutions · Provides guidance to site staff and CRAs on the source documentation to be collected for the various clinical endpoints and all Serious Adverse Events (SAEs) · Ensures medical consistency, accuracy, and validity of the clinical study data · Ensures medical consistency and thoroughness of the endpoint package · Provides assistance to the CEC chair and independent reviewers on the adjudication process · Provides training to CRAs and new Medical Monitors, on the protocol, · Performs periodic review of the Electronic Data Capture (EDC) and the Safety Database systems to ensure all reported information is medically sound and compliant with the protocol and applicable regulatory requirements · Ensures that timelines of SAE reporting are respected and that subsequent reconciliations are performed in a timely manner · Writes narrative for SAEs and other AEs, as specified by the study protocol · Contributes to the preparation of regulatory submissions and responds to questions from regulatory agencies regarding the safety and efficacy of investigational products · Builds strong and effective relationships with sponsor and vendors to enhance the department's workflow · Participates in ongoing process improvement to enhance departmental and organizational effectiveness · Participate at the Investigator Meetings REQUIREMENTS  · Medical degree or Doctor of medicine · Bilingual verbally and written (French/English) ( mandatory ) · A minimum of 3 years of experience in the life sciences industry, pharmaceutical or biotechnological industry in a multitherapeutic field that involves Phase I through IV clinical trials. A minimum of one (1) year of clinical research experience with emphasis on cardiovascular clinical research methodology · Experience in preparing regulatory documentation for submission to regulatory authorities like Health Canada, Food and Drug Administration, European Medicines Agency · Excellent written, oral (including presentation), interpersonal and negotiation communication skills. · Ability to research multiple healthrelated databases for complex scientific information, synthesize the information quickly and able to explain it to both the public and scientific peers · Ability to be flexible when it comes to lastminute and tight deadline work assignments · Ability to manage multiple tasks with enthusiasm and prioritize workload with a quality focused approach, i.e., excellent organizational skill · Must have strong analytical and problemsolving skills. · Ability to escalate issues to departmental management as required · Excellent knowledge of clinical research methodology and solid understanding of clinical studies, ICH E2AE2F, E6 and E9, GCP, and other applicable regulatory requirements · Excellent knowledge of Statistical analysis methods and reporting guidelines · Excellent knowledge of medical terminology and clinical trial design · Experience using Safety Databases (e.g. ArisGlobal LSMV&amp;LSRA) and eAdjudication Platform · Computer literacy and proficient in Microsoft Office including SharePoint and Excel, Adobe Acrobat, and document management systems WORK CONDITIONS • 35 hours weekly base • Preapproved overtime paid • Flexible work schedule for workfamily 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, wellbeing, and quality of work life of employees, including free access to the EPIC Center, as well as various other benefits. TO SUBMIT YOUR APPLICATION : · Deadline to apply: Open until the position is filled  Please send your cover letter and resume to:  rh@seriant.org 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.

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