Clinical Research Manager

hace 2 semanas

Municipio de San Vicente Ferrer, Colombia MSD A tiempo completo

Job Description:


The
Clinical Research Manager role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.

The
Clinical Research Manager could be responsible for a particular study for several countries in a cluster.

Responsibilities include, but are not limited to:

  • Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
  • Responsible for project management of the assigned studies: proactively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for performance for assigned protocols in a country in compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate manager and/or functional vendor and internal management as needed.
  • Performs Quality control visits as required Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports Clinical Research Associates as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
  • Responsible for creating and executing a local risk management plan for assigned studies.

Experience Requirements:

  • Bachelor degree in Science
  • 56 years of experience in clinical research
  • Fluent Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Knowledge in Project Management and site management.
  • Strong organizational skills with demonstrated success required.
  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head /CRD
  • Requires strong understanding of local regulatory environment
  • Strong scientific and clinical research knowledge is required
  • Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.

Who we are


We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.


What we look for


Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.

Here, you have that opportunity.

You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.


We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Employee Status:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:
R224275

  • Senior Clinical Project Manager, Internal Medicine

    hace 2 semanas

    San Vicente Ferrer, Colombia Novasyte A tiempo completo

    POSITION TITLE: Senior Project Manager REPORTS TO: Director, Project Management or Designee BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the...

  • Clinical Operations Manager

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia MSD A tiempo completo

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Head COMs or, the person is responsible for execution and oversight...

  • Research Assoc Ii Evidera

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Thermo Fisher Scientific A tiempo completo

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns. Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global...

  • Clinical Operations Manager

    hace 4 semanas

    San Vicente Ferrer, Colombia MSD A tiempo completo

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Head COMs or, the person is responsible for execution and...

  • Sr Site Activation Specialist

    hace 4 semanas

    San Vicente Ferrer, Colombia Syneos Health Clinical A tiempo completo

    **Description** **Senior Site Activation Specialist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...

  • Clin Data Team Lead

    hace 4 semanas

    San Vicente Ferrer, Colombia Thermo Fisher Scientific A tiempo completo

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...

  • Sr Health Economist Modeler

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Thermo Fisher Scientific A tiempo completo

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns. Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global...

  • Study Start Up Associate Ii

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia ICON A tiempo completo

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

  • Cra Ii

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia ICON plc A tiempo completo

    As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity.You will have an opportunity to work in a solid...

  • Medical Science Liaison, Colombia

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Ultragenyx Pharmaceutical A tiempo completo

    Why Join Us? Be a hero for our rare disease patients_Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work....

  • Study Start Up Associate Ii

    hace 4 semanas

    San Vicente Ferrer, Colombia ICON A tiempo completo

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

  • Gaming Product Manager

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Astropay A tiempo completo

    We are looking for a Gaming Product Manager to join our teamSince its inception in 2009, AstroPay has grown from a prepaid voucher provider in Brazil to become the online payment solution of choice for a rapidly growing global community of millions of passionate users in Latin America, Asia, Africa and Europe.We aim to be 'more than just a wallet': from...

  • Medical Science Liaison, Colombia

    hace 1 semana

    San Vicente Ferrer, Colombia Ultragenyx Pharmaceutical A tiempo completo

    **Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...

  • Project Manager Ii

    hace 2 semanas

    San Vicente Ferrer, Colombia Labcorp A tiempo completo

    Typically under the direction of a Senior Project Manager/Project Director, the Project Manager oversees and manages domestic, regional and/or global projects. Responsibilities typically include managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders effectively ensuring that variance from plan is proactively and...

  • Gaming Product Manager

    hace 4 semanas

    San Vicente Ferrer, Colombia Astropay A tiempo completo

    **We are looking for a** Gaming Product Manager t**o join our team!** Since its inception in 2009, **AstroPay** has grown from a prepaid voucher provider in Brazil to become the online payment solution of choice for a rapidly growing global community of millions of passionate users in Latin America, Asia, Africa and Europe. We aim to be ‘more than just a...

  • Cluster Finance Manager

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in 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 more than 130...

  • Impact Data Manager

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Kiva A tiempo completo

    About us:Kiva ) is an international nonprofit with a mission to expand financial access to help underserved communities thrive. We run a global marketplace platform to crowdfund microloans for financially excluded entrepreneurs, farmers and students around the world. Through Kiva Capital, we serve as a bridge between large scale impact first investors and...

  • Business Intelligence Analyst 1

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Novasyte A tiempo completo

    Únete a nosotros en nuestro emocionante trayecto IQVIAes The Human Data Science Company, enfocada en el uso de datos y ciencia para ayudar a los clientes de la salud a encontrar mejores soluciones para sus pacientes. Formada a partir de la fusión de IMS Health y Quintiles, IQVIA ofrece una amplia gama de soluciones que aprovechan los avances en...

  • Auxiliar de Farmacovigilancia

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Novasyte A tiempo completo

    Únete a nosotros en nuestro emocionante trayecto IQVIAes The Human Data Science Company, enfocada en el uso de datos y ciencia para ayudar a los clientes de la salud a encontrar mejores soluciones para sus pacientes. Formada a partir de la fusión de IMS Health y Quintiles, IQVIA ofrece una amplia gama de soluciones que aprovechan los avances en...

  • Business Intelligence Analyst 1

    hace 2 semanas

    San Vicente Ferrer, Colombia Novasyte A tiempo completo

    ¡Únete a nosotros en nuestro emocionante trayecto! IQVIAes The Human Data Science Company, enfocada en el uso de datos y ciencia para ayudar a los clientes de la salud a encontrar mejores soluciones para sus pacientes. Formada a partir de la fusión de IMS Health y Quintiles, IQVIA ofrece una amplia gama de soluciones que aprovechan los avances en...