Medical Monitor/moniteur Médical, Canada

5 months ago

Remote, Canada Innovaderm Research Full time

**This role will be perfect for you if**:

- You are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project
- You skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials
- You are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary

**RESPONSIBILITIES**

****

**Protocols and projects**
- Keep current on study protocol, study protocol amendments, Investigator’s Brochure (IB), additional safety information made available during the course of the study, and relevant clinical research guidelines involving the therapeutic indication
- Develop or review Medical Monitoring plan
- Provide project team training on study protocol and/or therapeutic area/indication.
- Prepare for, attend, and present at Investigators’ Meetings
- Prepare for and attend Safety Review Meetings, as needed
- Provide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters
- Provide ongoing medical support during the study to investigators, site personnel, and monitors
- Provide advice to the sites on protocol-related issues including: questions related to the protocol inclusion and exclusion criteria, concomitant medications/medical conditions, follow-up visits due and guidance on prohibited medication
- Review lab critical values and alerts
- Provide emergency un-blinding code-break of randomized treatment assignment

**Medical dermatology advisory role **
- Provide project-related medical consultation to the Innovaderm project team members during business hours throughout the duration of the study
- Escalate to the Project Manager or Sponsor any issues requiring medical input and significant safety or data integrity concerns identified during review of data or site contact
- Attend meetings with Innovaderm project team members (PM, DM, stats, CRO) and/or Sponsor, as required
- Review protocol deviation listings to address potential safety concerns; perform impact assessment; and identify any potential trends
- Review coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly
- Review clinical study report

**Data Activities**
- Participate in the Central Monitoring activities with site data signal detection and risk management activities for the safety portion; participate in the safety review for RBM and central monitoring
- Provide medical review of SAE form, and reviews SAE causality assigned by the Investigator.
- Write and/or review SAE narratives
- Work with the Pharmacovigilance Services provider or Marketing Authorization Holder (MAH) to review SAEs and follow-up on outstanding safety queries, interact with Sponsor and discuss safety issues with sites, as needed
- Serve as a non-voting member of the committee to convene and organize proceedings, as applicable

**Safety Medical Monitoring and SAE Reporting Activities**
- Provide assistance in pharmacovigilance activities
- Assist Innovaderm/Sponsor in choosing committee members
- Serve as a non-voting member to convene and organize proceedings, as applicable
- Develop operating guidelines in conjunction with committee members and submit these to Sponsor for review
- Support business development activities with proposal development and sales presentations.
- Participate in feasibility discussions relating to specific project proposals
- Assist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities
- Perform other related duties as assigned or requested by the Director, Scientific and Regulatory Affairs
- Perform other related duties as assigned or requested by the Chief Medical Officer.

**Requirements**:
**PROFILE**

**Education
- Medical degree;
- Completed residency training in either Dermatology or Rheumatology

**Experience
- Minimum 3 years experience in CRO or pharmaceutical industry in clinical research, with experience as medical monitor/medical reviewer/drug safety physician for clinical trials
- At least 3 years of experience as Medical Monitor which should include dermatology and/or rheumatology studies
- being trained/board certified as a dermatologist or a rheumatologist is a plus

**Knowledge and skills**
- Excellent knowledge of the drug development process.
- Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus.
- Outstanding ability to work independently with mínimal supervision, ability to work effectively within a team, and matrix environment.
- Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities.
- Excellent verbal and written communication skills as well as interpersonal skills.
- Client-focused approach to work;
- Good knowled

  • Medical Monitor

    5 months ago

    Remote, Canada PSI CRO Full time

    **Company Description** PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. PSI **Medical Monitors **provide medical input to global...

  • Administrative Specialist

    5 months ago

    Remote, Canada GSH Medical Full time

    **Position Title**: Medical Administration and Reception - Specialist Office **Reports to**: Regional Operations Manager **Job Status**:Maternity Leave Cover (12mo) - with the possibility of full time permanent We are looking for a skilled off site / work from home medical receptionist for our Chronic Pain division. You will be directly supporting our...

  • Assistant(E) Administratif(Ve)

    5 months ago

    Remote, Canada Clinique Privée - Soins Infirmier Mobile Full time

    **POSTE DE TÉLÉTRAVAIL MAIS LE/LA CANDIDAT(E) DOIT HABITER DANS LA GRANDE RÉGION DE MONTRÉAL** **Vous aimez le service à la clientèle, vous êtes plein d'énergie et vous avez le SOUCI DU DÉTAIL? Ce poste est peut-être fait pour vous !** **QUALIFICATIONS REQUISES (OBLIGATOIRE)**: - Formation académique : Détenir un diplôme d’études...

  • First-aid & Survival Kits & Medical Devices Sales

    6 months ago

    Remote, Canada Medik-Aid SurvivalAid Full time

    **Please note that this position is COMMISSION based only** **Responsibilities**: - Develop and maintain relationships with clients - Generate new business through cold calling, networking, and other sales techniques. - Meet or exceed monthly sales targets. - Provide exceptional customer service to clients. **Qualifications**: - Minimum of 2 years of...

  • Medical Operations Coordinator

    6 months ago

    Remote, Canada VIKAND Solutions LLC Full time

    VIKAND's mission is to provide the highest quality, timely, cost-effective healthcare possible with the support of our team of skilled professionals and the latest technology. - As VIKAND positions itself for long-term growth, we are currently seeking self-starters to join us in the position of _**Medical Operations Coordinator**_. _ - Fluency in...

  • Sales Marketing Manager

    6 months ago

    Remote, Canada ROI ADS LLC Full time

    **We will reach out to individuals residing in Canada who possess a valid work permit.** Join Rejuve Clinics, a burgeoning medical spa dedicated to rejuvenation and wellness, in our search for a seasoned Sales Marketing Manager to enrich our team. As the Marketing Manager, your primary role will involve spearheading all marketing endeavors to spotlight our...

  • Principal Medical Writer

    5 months ago

    Remote, Canada Parexel Full time

    Canada, Remote Canada **Job ID** R0000014031 **Category** Medical Writing **ABOUT THIS ROLE**: At Parexel you’ll team up with some of the best minds in the industry to get new treatments to the patients who need them most. Parexel is one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more...

  • Product Specialist

    5 months ago

    Remote, Canada Timeless Medical Systems Full time

    **Job Summary**: Your employment duties will consist of those of a Product Specialist as required by the Company and listed below. This list is not to be taken as fixed or exhaustive, however, and you will be expected to perform any reasonable employment task assigned by a leader. The Product Specialist will work closely with cross-functional teams to...

  • Operations Coordinator

    6 months ago

    Remote, Canada Auscan Medical Inc. Full time

    Auscan is a hands-on, experienced, and customer-focused Occupational Health & Safety and Emergency Services provider. We support our clients through the development and implementation of tailored and sustainable solutions. Location: Kelowna, BC or Remote About Us: Auscan Medical Inc. is a growing provider of industrial emergency services and safety...

  • Clinical Specialist

    5 months ago

    Remote, Canada Timeless Medical Systems Full time

    **Job Summary**: Your employment duties will consist of a Clinical Specialist as required by the Company and listed below. This list is not to be taken as fixed or exhaustive however, and you will be expected to perform any reasonable employment task given by a leader. The Clinical Specialist will engage our customers on the frontline, they will assist the...

  • District Manager, Gastroenterology, Western Canada

    6 months ago

    Remote, Canada AbbVie Full time

    **Company Description** Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada whereby 98% of our employees are proud to say they work for AbbVie and...

  • Bilingual Administrative Agent

    5 months ago

    Remote, Canada Medical Weight Management Centre of Canada Full time

    **We’re looking for outstanding bilingual administration contractors to support The Medical Weight Management Centre of Canada (MWM).** MWM is a national, virtual weight management centre based in Hamilton, ON. As the team member responsible for managing the patient-journey, you ensure every patient has an excellent experience in our program by: -...

  • Project Manager

    7 months ago

    Remote, Canada The Lockwood Group, LLC Full time

    **About Lockwood**:Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to address their objectives through medical communications. Our clients count on us to challenge their assumptions and help them creatively navigate around obstacles. From strategy...

  • Freelance General Transcription Only

    5 months ago

    Remote, Canada Transcription Canada Full time

    '''Duties:''' - _ **Communicate effectively with clients and colleagues**_ - there are different kinds of transcription jobs; general, market research transcription, medical transcription and legal transcription. The audio files are varied and can include focus groups for market research, interviews, meetings, phone calls, zoom calls etc. Our primary...

  • Clinical Trial Manager Ii

    5 months ago

    Remote, Canada Syneos - Clinical and Corporate - Prod Full time

    **Description** **Clinical Trial Manager II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

  • Mva Patient Advisor

    6 months ago

    Remote, Canada Medical Marijuana Consulting Clinic - A Sensi Brands Company Full time

    **Position**: Full Time - MVA Patient Advisor **Location**: Richmond Hill, ON - Remote **Expected Start Date**: As soon as possible **Annual Base Salary Starting At**: $45,000 **About Medical Marijuana Consulting Clinic (MMC)** Medical Marijuana Consulting Clinic (a Sensi Brands company) is Canada’s leading provider of medical cannabis access and...

  • Principal Biostatistician

    6 months ago

    Remote, Canada Syneos Health Clinical Full time

    **Description** **Principal Biostatistician (GMA - Medical Affairs and Immunology experience required)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our...

  • Part-time Medical Billing Agent

    5 months ago

    Remote, Canada MedSleep Inc. Full time

    At MedSleep, skilled, dedicated, enthusiastic employees are at the heart of everything we do. We are committed to building and nurturing a great place to work, learn, and develop. We are proud of our people and our company. We have a great career opportunity for someone looking to join a growing team of health professionals! At MedSleep, we are committed to...

  • Technical Service Representative

    5 months ago

    Remote, Canada BOMImed Inc. Full time

    BOMImed Inc., is looking for an outgoing, passionate, self-starter who has an interest in travel, technical service and healthcare to join our Technical Service team for the Atlantic Canada territory. With a nationwide service team and a central manufacturing facility located in Winnipeg, Manitoba, Canada, BOMImed has become a leading full-line supplier of...

  • Architectural Sales Representative in Alberta Canada

    5 months ago

    Remote, Canada Allied Technical Sales Full time

    ATS has grown to represent eight world class Architectural brands. These manufacturers' products can be found in exterior and interior settings within commercial, education, hospitality, medical, and long-term care industries. Our dedicated and knowledgeable internal and external sales staff located across Canada are committed to delivering the highest level...