Medical Data Review Assoc Manager

hace 3 meses


Ciudad de México CDMX Fortrea A tiempo completo

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers 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, Fortrea is transforming drug and device development for partners and patients across the globe.

Collaborates in the development of Central Monitoring proposal text and review of costing,contributes to proposal strategy and development when Central Medical Review is included
 Support Sponsor presentations / bid defenses.
 Ensures that tracking and status reporting are performed in a timely and accurate manner.
 Applies data to recommend any patient safety concerns
 Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
 Contributes to the Risk Assessment and Categorization Tool for topics related to medical review and considers risks when planning Xcellerate® Medical Review configuration
 Supports the Data Expert with Critical Data and Process Definition and EDC design implementation
 Supports the development of medical review requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
 Drafts and finalizes the Central Medical Review Configuration Plan. Maintains this Plan throughout the study including re-versioning as required.
 Drafts Central Monitoring /Central Medical Review Plans in collaboration with the Central Monitoring Manager (if applicable) and Project Physician and updates these on an ongoing basis including the refinement of visualizations and any change in data.
 Manages configuration of Medical Review (XMR) tool, programming of study specific visualizations included in XMR and performs user acceptance testing of the tool
 Performs ongoing Central Medical Review, discusses findings with Project Physician (internal and/or client) and ensures that identified issues are followed to resolution, and where required, that a report is written.
 Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
 Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
 Collaborates with other Central Monitoring activities to ensure consistency and effectiveness.
 Evaluates and collates process improvement suggestions and submits to leadership.
 Evaluates and submits ideas and justification for improved systems and tools to leadership.
 Provide training on the project and process to new team members.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

Privacy Statement

.



  • Ciudad de México, CDMX Hasbro Inc. A tiempo completo

    The Assoc Manager Customer Marketing main goal is to drive a sustainable go to market strategy for modern channel specifically all Walmart format stores (Supercenter, Bodega Aurrera, Walmart Express). It’s responsible to lead and follow up the strategy for this channel, including portfolio, promotional, channel / customer and ecommerce plans to achieve...

  • Medical Manager

    hace 3 meses


    Ciudad de México, CDMX Biogen A tiempo completo

    **Job Description** About This role** The Medical Manager leads medical strategy in Alzheimer, through the following: Medical positioning: Build the therapeutic area within the company, in Mexico, internally and externally, achieving the understanding of the unmet needs of patients and physicians in the area and creating comprehensive plans that include...


  • Ciudad de México, CDMX Hasbro Inc. A tiempo completo

    Assoc Manager Customer Marketing - Ecomm - Coordinate key account managers, agencies and brand managers to create customer focused plans that align commercial, marketing, company, and sales goals. - Develop and nurture direct relationships with ecommerce agency team and global teams aligning to full-year planning agendas. - Lead the implementation of...


  • Ciudad de México, CDMX Icon plc A tiempo completo

    Medical Affairs Specialist - Mexico City ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Medical Affairs Specialist Site: Mexico City Provide...

  • Medical Monitor

    hace 3 meses


    Ciudad de México, CDMX 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...


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

    DE&I Statement For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve...


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

    DE&I Statement For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve...

  • Medical Manager

    hace 4 meses


    Ciudad de México, CDMX AbbVie A tiempo completo

    **Company Description** **Responsibilities**: - Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance / participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/Area literature. - Provide expert medical/scientific advice...

  • Assoc I Pss

    hace 1 mes


    Ciudad de México, CDMX Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in...


  • Ciudad de México, CDMX Novo Nordisk A tiempo completo

    Medical Excellence Operations Manager **Category**:Clinical Development**Location**:Ciudad de México, Ciudad de México, MX- **Position Description** As a Medical Excellence Operations Manager at Novo Nordisk, you will: - Create, track, and report on progress of KPIs, including CMR monthly dashboard performance reviewsm as week as ensure relevant KOL...


  • Ciudad de México, CDMX Pfizer A tiempo completo

    Medical Scientific Liaison (MSL) Internal Medicine Location: CDMX, Mexico- The Medical Scientific Liaison (MSL) will be in charge of delivering updated scientific information to a broader group of healthcare professionals.- The role of the Medical Scientific Liaison will be to provide essential information which in most instances will be medical, but it...


  • México Rejuv Medical A tiempo completo

    The Manager oversees and manages the daily operations of the clinic. You are responsible for ensuring a smooth, positive and patient focused environment. This includes, but is not limited to, managing and performing the functions of: registration, financial counseling, telephone answering, patient billing activities, scheduling of staff, supervising and...


  • Ciudad de México Novartis A tiempo completo

    391263BR **Medical Evidence and Execution Manager**: Mexico **About the role** Location: Mexico City About the role: We are seeking a Medical Evidence & Execution Manager who will co-lead the CPO strategy and implement all local evidence generation initiatives. This person will ensure the production of high-quality data to support core strategic pillars...


  • Ciudad de México, CDMX Pfizer A tiempo completo

    MAIN REPONSIBILITIES / DUTIES- The Medical Scientific Liaison (MSL) will be in charge of delivering updated scientific information to a broader group of healthcare professionals.- The role of the Medical Scientific Liaison will be to provide essential information which in most instances will be medical, but it can also be purely technical linked to other...


  • Ciudad de México, CDMX GSK A tiempo completo

    **Site Name**: Field Worker - MEX **Posted Date**: Sep 3 2024 The MSL role provides non-promotional medical support, helping ensure the safe and effective use of GSK medicines, by creating effective scientific interactions with Healthcare Professionals and professional associations. Through deep expertise and strong external interactions, the MSL plays a...


  • Ciudad de México, CDMX Novo Nordisk A tiempo completo

    Diabetes Injectables Medical Manager **Category**:Medical Affairs**Location**:Ciudad de México, Ciudad de México, MX- **The position** - As an Injectable Medical Manager at Novo Nordisk, you will:- Build relationships and scientific advocacy with key opinion leaders to strengthen NN therapeutic areas knowledge- - Lead local medical strategy.- - Secure...

  • Clinical Data Reviewer

    hace 6 meses


    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...


  • Ciudad de México, CDMX Icon plc A tiempo completo

    Program Manager, Clinical Data Science, Colombia, Home ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We have an incredible opportunity for a...

  • Medical Advisor

    hace 3 meses


    Ciudad de México, CDMX Amgen A tiempo completo

    **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...


  • Ciudad de México, CDMX Zoetis A tiempo completo

    *** The Technical Medical Manager in the veterinary animal health industry is responsible for providing technical support and expertise to veterinary professionals and clients. This role involves developing and implementing medical protocols, overseeing clinical operations, and ensuring the highest standards of animal care. The Technical Medical Manager...