Medical Monitor

hace 4 meses

Buenos Aires, Argentina Innovaderm Research A tiempo completo

The Medical Monitor provides medical and scientific support to clinical research programs. The Medical Monitor will perform thorough data review to ensure data integrity and subject safety oversight, and will communicate with sites, investigators, and internal project team members to ensure questions are promptly addressed.


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
  • Assess the impact of any prohibited medication taken on study and evaluate any appropriate action for the subject
  • Evaluate the appropriateness of any dropout subject replacement
  • 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
  • Verify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study
  • Review subject safety-related data listings for the purpose of identifying potential trends, unreported protocol deviations related to safety assessments, AEs, and SAEs; and address safety concerns
  • 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
  • Assess if any stopping rule was met and evaluate any appropriate action or follow up with the subject, if applicable
  • 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


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.


Our company:

The work environment 

 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

 

In this position, you will be eligible for the following perks: 

  • Flexible work schedule / work schedule :
  • Home-based position
  • Ongoing learning and development 

 

About Innovaderm  

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. 

 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 


Innovaderm only accepts applicants who can legally work in Argentina


Education

  • Medical degree;


Experience

  • Dermatologist with 3 years of Medical Monitoring experience or an MD with 3 years of Medical Monitoring experience in dermatology


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 minimal 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 knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines

  • Medical Monitor

    hace 1 mes

    Buenos Aires, Argentina Innovaderm Research A tiempo completo

    Job Title: Medical MonitorWe are seeking a highly skilled Medical Monitor to join our team at Innovaderm Research. As a Medical Monitor, you will play a critical role in ensuring the integrity and safety of our clinical research programs.Key Responsibilities:Provide medical and scientific support to clinical research programs, ensuring data integrity and...

  • Medical Monitor

    hace 2 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    **Company Description** PSI is a leading Contract Research Organization with more than 25 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...

  • Medical Monitor

    hace 4 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Job DescriptionPSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.Responsibilities:Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical mattersCollaborate with internal...

  • Medical Science Specialist

    hace 4 semanas

    Buenos Aires, Buenos Aires C.F., Argentina PSI CRO A tiempo completo

    Medical Monitor Role at PSI CROAt PSI CRO, we seek a skilled Medical Monitor to join our team of medical professionals. The successful candidate will provide medical input to global clinical studies, collaborating with internal departments to prepare clinical development plans and review clinical data.Key Responsibilities:Advise clients and project teams on...

  • Medical Assistant

    hace 6 meses

    Buenos Aires, Argentina ProMedix Health A tiempo completo

    **Medical Assistant** ProMedix Health is looking for a Medical Assistant to join our Remote Patient Monitoring Care Team with a focus on patient onboarding and monitoring of elderly patient care. You will train and educate elderly patients on the use of in-home medical devices and monitor patient submitted physiologic data via the company’s virtual care...

  • Medical Biller

    hace 2 meses

    Buenos Aires, Argentina DSP Health A tiempo completo

    _Seeking an Experienced _**Medical Biller **_to Join Our Team!_ **Job Summary**: **Key Responsibilities**: - Prepare, submit, and track medical claims - Follow up on unpaid or denied claims, and manage re-submissions - Reconcile accounts, resolve billing discrepancies, and ensure accurate payment processing - Stay current with healthcare regulations,...

  • Centralized Monitor, School

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Join IQVIA with our CM School (LATAM)! Do you have previous experience in the industry? Are you interested in being part of a global remote monitoring team? Don't miss this opportunity where you can join our team with trainings to develop yourself as a remote monitor! Job Overview A Central Monitor is a key skilled and clinically experienced team member...

  • Medical Scribe

    hace 6 meses

    Buenos Aires, Argentina Philippines Outsourcing Solution A tiempo completo

    Job Title: Medical Scribe Limitlessli is a staffing company that recruits, hires, and manages long-term remote staff for growing businesses in the USA. - Type of Work: Full-time, permanent - Working hours: 9 am to 6 pm EST (Monday to Friday) Roles and Responsibilities: - Transfer data from the providers into database systems - Type in the data provided,...

  • Virtual Medical Receptionist

    hace 3 meses

    Buenos Aires, Argentina Vital Virtuals Global HR Solutions LLC A tiempo completo

    **Company Overview**: Vital Virtuals is a leading provider of remote healthcare support services. As we expand, we seek a skilled Remote Medical Receptionist/Admin, **proficient in English (C1 or above)** to join our team and contribute to our mission of revolutionizing healthcare delivery. **Qualifications**: - Bachelor's degree in healthcare...

  • Virtual Medical Biller

    hace 3 meses

    Buenos Aires, Argentina Vital Virtuals Global HR Solutions LLC A tiempo completo

    **Company Overview**: Vital Virtuals is a leading provider of remote healthcare support services. As we expand, we seek a skilled Remote Medical Biller and Coder, proficient in English (C1 or above) to join our team and contribute to our mission of revolutionizing healthcare delivery. **Key Responsibilities**: - Verify patient insurance coverage and...

  • Virtual Medical Receptionist

    hace 9 horas

    Buenos Aires, Argentina Vital Virtuals Global HR Solutions LLC A tiempo completo

    **Company Overview**: Vital Virtuals is a leading provider of remote healthcare support services. As we expand, we seek a skilled Remote Medical Receptionist/Admin, **proficient in English (C1 or above)** to join our team and contribute to our mission of revolutionizing healthcare delivery. **HOW TO APPLY**: NOTE: Please share a G-Drive link to your resume...

  • Clinical Study Monitor

    hace 4 semanas

    Buenos Aires, Buenos Aires C.F., Argentina CDS Fortrea Inc. A tiempo completo

    As a leading global contract research organization (CRO), CDS Fortrea Inc. provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, we are transforming...

  • Virtual Medical/dental Scribe

    hace 3 meses

    Buenos Aires, Argentina Vital Virtuals Global HR Solutions LLC A tiempo completo

    **Company Overview**: Vital Virtuals is a leading provider of remote healthcare support services. As we expand, we seek a skilled Remote Medical Scribe, proficient in English (C1 or above) to join our team and contribute to our mission of revolutionizing healthcare delivery. **Qualifications**: - Proven experience of 1-2 years as a Medical/Dental Scribe or...

  • Virtual Medical/dental Scribe

    hace 9 horas

    Buenos Aires, Argentina Vital Virtuals Global HR Solutions LLC A tiempo completo

    **Company Overview**: Vital Virtuals is a leading provider of remote healthcare support services. As we expand, we seek a skilled Remote Medical Scribe, proficient in English (C1 or above) to join our team and contribute to our mission of revolutionizing healthcare delivery. **HOW TO APPLY**: NOTE: Please share a G-Drive link to your resume and a one-minute...

  • Wfh - Medical Document Retrieval Va

    hace 6 meses

    Buenos Aires, Argentina Staffilocity A tiempo completo

    The main responsibility of a Medical Document Retrieval VA is to obtain documents from medical facilities or clients and ensure that documents are stored efficiently and easily accessible. It also entails developing and implementing management and control strategies. **Qualifications** - Excellent English (oral and written) communication skills - Experience...

  • Admissions Coordinator

    hace 5 meses

    Buenos Aires, Argentina Philippines Outsourcing Solution A tiempo completo

    **Job Title: Telehealth Sales or Admissions Coordinator** **Limitlessli **is a staffing company that recruits, hires, and manages long-term remote staff for growing businesses in the USA. **Location**:Remote (permanent work from home) - **Type of Work**:Full-time - **Work Hours**:Mon - Fri, EST **Summary: Responsible for calling patients to discuss their...

  • Medical Billing Coordinator

    hace 6 meses

    Buenos Aires, Argentina Sagan A tiempo completo

    **Position: Medical Billing Coordinator - Latam** **Location**:Remote (EST Timezone) **Work Schedule**:Monday-Friday, 08:00 AM - 04:00 PM EST **About Us**: Are you interested in working with a company that values people and has a passion for service? As a Medical Billing Coordinator, you are an important link between the patients, providers, and insurance...

  • Medical Operations Specialist

    hace 8 meses

    Buenos Aires, Argentina ABBVIE A tiempo completo

    Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world. We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset. From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to...

  • Sourcing Team Manager

    hace 6 meses

    Buenos Aires, Argentina Health Supply 770 Inc A tiempo completo

    Overview: **Responsibilities**: - Team Management: - Lead and mentor a team of sourcing agents, providing guidance and support to ensure the team's success. - Set clear objectives and KPIs for the team, and regularly monitor progress towards goals. - Conduct regular performance evaluations and provide constructive feedback to team members. - Strategic...

  • Medical Sales Manager

    hace 2 semanas

    Buenos Aires, Argentina Aplus Consulting A tiempo completo

    Functional skills and knowledge Demonstrate a strong understanding of clients' knowledge of industry/business/products Demonstrate strong client management and communication skills with the ability to solve problems. Proven project management skills Strong analytical background and knowledge of statistical analysis methods Demonstrate fluency in English,...