Medical Data Reviewer

hace 2 semanas

Ciudad de México ICON plc A tiempo completo

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

**Job Overview**:
The Medical Data Reviewer (MDR), in close cooperation with the Medical Director (MD), sets up and coordinates the medical data review process, assists with medical data review and manages medical queries. The MDR role requires a close collaboration with various members of the Biometrics team, most frequently but not limited to the Data Coordinator & Lead Data Manager and Clinical Data Scientist. Specifically, the MDR reviews medical data for consistency and medical plausibility and ensures that the data is comprehensive from a medical point of view across different studies and projects.

**Responsibilities**:
**The role**:

- Prepares listings with medical data (vital signs, lab data, medical history, concomitant medication, etc.) for medical review for plausibility and consistency.
- Under close supervision, coordinates and drafts the Medical Data Review Plan (MDRP) according to PRA standards, contract and client expectations (AWARD report / Proposal). Assures MDRP consistency with other project plans i.e. Data Management Plan (DMP), Edit Check Plan, Data Transfer Plan (DTP)), contracted scope of work, and PRA SOPs and procedures
- Under close supervision, coordinates project-specific tasks such as review of the electronic Case Report Form (eCRF), and CRF Completion Guidelines (CCG).
- Manages queries and Data Clarification Forms (DCF) in cooperation with PRA MD, Sponsor and other departments.
- Participates in or attends internal and client Kick-Off meetings, as needed.
- Reviews the protocol together with the PRA MD to determine which Standard Objects listings will be appropriate for medical review and decides whether any customized listings are needed per study specific requirements.
- Reviews and approves all test outputs of listings in collaboration with the MD and Biometrics team.
- Plans and coordinates together with MD the medical review cycles and runs standard/customized listings as needed according to timeline.
- Ensures a structured medical query management
- Raises and responds to medical queries following through until query resolution.
- Reviews and responds to Quality Control (QC) findings, as needed
- Supports business development activities by providing input into feasibility activities related to medical data review

**Qualifications**:
**You will need**:

- A Minimum of 2 years of experience of relevant clinical Trials industry experience
- Degree in Health (E.g., Nurse, Pharmacist)
- Basic knowledge of medical terminology and coding systems
- Advanced English for Reading, Writing and Speaking
- Excellent written and verbal communication
- Advanced Office Pack
- Experience working within a CRO / Pharma is highly preferred
- Knowledge of ICH guidelines

**Note: Hybrid Position: 2 days at home, 3 days at the office**

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  • Medical Data Reviewer

    hace 4 semanas

    Ciudad de México ICON A tiempo completo

    **Medical Data Reviewer** **JR101315** **Site: Mexico City** At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set...

  • Medical Data Reviewer

    hace 1 semana

    Ciudad de México, Ciudad de México ICON A tiempo completo

    Medical Data ReviewerJR101315Site: Mexico CityAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization:...

  • Medical Data Reviewer

    hace 1 semana

    Ciudad de México, Ciudad de México ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...

  • Medical Data Reviewer

    hace 1 semana

    Ciudad de México, Ciudad de México ICON plc A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...

  • Medical Data Reviewer

    hace 3 semanas

    Ciudad de México ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Medical Reviewer Ags

    hace 3 semanas

    Ciudad de México Alcon A tiempo completo

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...

  • Medical Reviewer Ags

    hace 1 semana

    Ciudad de México, Ciudad de México Alcon A tiempo completo

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients...

  • Clinical Data Reviewer

    hace 1 semana

    Ciudad de México PSI CRO A tiempo completo

    **Company Description** We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to...

  • Clinical Data Reviewer

    hace 1 semana

    Ciudad de México, Ciudad de México PSI CRO A tiempo completo

    Company DescriptionWe are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...

  • Medical Consultants Medical Director

    hace 1 semana

    Ciudad de México, Ciudad de México myGwork A tiempo completo

    MD required with specialization in Oncology or Hemato-Oncology (active medical license preferred). Candidates should have a combination of clinical experience and industry experience. Clinical experience in treating patients associated with the applicants training (comparable to 2 years) and one of the following:* Suitable clinical trial experience in a...

  • Medical Excellence Officer

    hace 1 semana

    Ciudad de México, Ciudad de México Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for...

  • Medical Excellence Officer

    hace 3 semanas

    Ciudad de México Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for...

  • Medical Office Assistant

    hace 1 mes

    Ciudad de México Caliber6 A tiempo completo

    Remote Medical Office AssistantWe are seeking an experienced and highly skilled individual for a full-time remote position for our medical office. The ideal candidate must possess the following qualifications: High-level Spanish fluency with excellent written and verbal communication skills Availability to work mostly during Eastern Standard Time (EST)...

  • Medical Affairs Intern Mexico

    hace 2 semanas

    Ciudad de México BioMarin A tiempo completo

    BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...

  • Quality Assurance Reviewer

    hace 2 semanas

    Ciudad de México Citi A tiempo completo

    This is an important role, reflective of the increasing criticality of strong risk and control focus within a large operations organisation such as ISG. _ **Job Background/context**: - The Information Services Group (ISG) is responsible for providing authoritative sources of reference data to our clients across the Institutional Client Services (ICG)...

  • Medical Education Specialist

    hace 3 semanas

    Ciudad de México Stryker A tiempo completo

    **What We Want** - ** Detail-oriented process improvers. **Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate. - ** Meticulous documenters. **Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. - **...

  • Technical Reviewer

    hace 1 semana

    Ciudad de México, Ciudad de México DNV A tiempo completo

    Local Unit & Position Description: Supply Chain Audits in DNV consist of assurance services (certification excluded) based on recognized standards (e.g., SEDEX - SMETA and SVA, RBA, SLCP, IFS GM) or customized protocols (e.g., Code of Conduct and Own Policies) aimed at assessing the compliance of organizations' suppliers base to defined requirements on...

  • Medical Office Assistant

    hace 1 mes

    Ciudad de México Caliber6 A tiempo completo $3,500 - $4,500

    Remote Medical Office AssistantWe are seeking an experienced and highly skilled individual for a full-time remote position for our medical office. The ideal candidate must possess the following qualifications:High-level Spanish fluency with excellent written and verbal communication skillsAvailability to work mostly during Eastern Standard Time (EST)...

  • Medical Office Assistant

    hace 3 semanas

    Ciudad de México Caliber6 A tiempo completo $3,500 - $4,500

    Remote Medical Office AssistantWe are seeking an experienced and highly skilled individual for a full-time remote position for our medical office. The ideal candidate must possess the following qualifications:High-level Spanish fluency with excellent written and verbal communication skillsAvailability to work mostly during Eastern Standard Time (EST)...

  • Medical Office Assistant

    hace 1 semana

    Ciudad de México, Ciudad de México Caliber6 A tiempo completo

    Remote Medical Office AssistantWe are seeking an experienced and highly skilled individual for a full-time remote position for our medical office. The ideal candidate must possess the following qualifications:High-level Spanish fluency with excellent written and verbal communication skillsAvailability to work mostly during Eastern Standard Time (EST)...