Medical Data Reviewer

hace 3 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 us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

**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
- Desirable experience in CRO / Pharma
- Knowledge of ICH guidelines

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

**To be successful in the role, you will have**:
**Benefits of Working in ICON**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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.

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