Site Manager

hace 2 semanas

Buenos Aires, Argentina 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 years.

Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

At Janssen, we're creating a future where disease is a thing of the past.

We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.

We focus on areas of medicine where we can make the biggest difference:
Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
We are Janssen.
Our mission drives us.
Our patients inspire us.

We are searching the best talent for
Site Manager to be in
Buenos Aires, Argentina (remote).

Purpose:
The Senior Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. The Sr.

Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study startup through to site closure.

Responsibilities may include assisting with site selection, pre-trial assessment, recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities.

The Senior Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols.

The Sr. Site Manager may contribute to process improvement, training and mentoring of other Site Managers.

  • As the Senior Site Manager, you will:
  • Act as primary local company contact for assigned sites for specific trials, may participate in site feasibility and/or pre-trial site assessment visits, and attend/participate in investigator meetings as needed.
  • Execute activities within site initiation and startup, preparation and conduct of site monitoring (including remote monitoring), site management and site/study closeout according to SOPs, Work Instructions and policies. As well as implement analytical risk based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits.
  • Ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
  • Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
  • Ensure site study supplies are adequate for trial conduct.
  • Ensure site staff complete data entry and resolve queries within expected timelines.
  • Ensure accuracy, validity and completeness of data collected at trial sites
  • Ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
  • Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
  • Fully documents trial related activities, in particular monitoring. Writes visit reports and followup letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
  • Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.

Qualifications:

  • A minimum of a bachelor's degree is required, preferably in a health or science related field.
  • A minimum of four (2) years of experience is required.
  • Experience in clinical trials or working as a Site Manager (CRA) is preferred.
  • Good knowledge of ICH-GCP, Standard Operating Procedures (SOP), local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines is preferred.
  • Strong IT skills in appropriate software and systems is preferred.
  • This position may require up to 25% of travel.
  • Proficiency in speaking and writing in English (intermediate level) is required.

GIFTS

  • Site Manager

    hace 4 semanas

    Buenos Aires, Argentina 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...

  • Senior Site Manager

    hace 3 semanas

    Buenos Aires, Argentina 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...

  • Senior Site Manager

    hace 2 semanas

    Buenos Aires, Argentina 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...

  • Site Manager

    hace 2 semanas

    Buenos Aires, Buenos Aires C.F., Argentina 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...

  • Site Manager

    hace 1 semana

    Capital Federal, Buenos Aires, Argentina 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...

  • Manager, Site Analytics

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Join our Team as Manager of Site AnalyticsWhat You Will Do:- Partner with clinical study teams to analyze historical IQVIA clinical performance data and external data sets to drive site identification for clinical projects- Formulate recommendations and present findings to stakeholders for data-driven site identification- Contribute to process improvement...

  • Assoc/site Activation Manager

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Internal Job Description Calling all experienced Site Activation Managers The Site Activation Manager (SAM) position within GSA team in IQVIA is our project manager for the startup phase in charge of design and implementation of our strategy towards sites activation from award until open to enrolment. The SAM leads and oversees our country operations teams...

  • Site Analytics, Associate Manager

    hace 1 semana

    Buenos Aires, Argentina Novasyte A tiempo completo

    Join us as a Site Analytics, Associate Manager! IQVIA is changing an entire industry through inspired innovation. Our People make the difference. We believe that great ideas can come from anywhere. Great products come from great ideas. And great ideas come from great people. We look for the very best people and then give them meaningful work to do. Join...

  • Manager, Site Analytics

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Join us as a Manager of Site Analytics! What You´ll Do We are looking for a creative analytical mind and an expert in clinical development to take on tough challenges that ultimately make a difference in the lives of patients around the world! If Human Data Science sounds intriguing to you, you need to join our team! You will partner with our clinical...

  • Site Analytics, Associate Manager

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Join us as a Site Analytics, Associate ManagerIQVIA is changing an entire industry through inspired innovation. Our People make the difference. We believe that great ideas can come from anywhere. Great products come from great ideas. And great ideas come from great people. We look for the very best people and then give them meaningful work to do. Join IQVIA...

  • Assoc/site Activation Manager

    hace 2 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Internal Job Description - Calling all experienced Site Activation Managers- The Site Activation Manager (SAM) position within GSA team in IQVIA is our project manager for the start-up phase in charge of design and implementation of our strategy towards sites activation from award until open to enrolment. The SAM leads and oversees our country operations...

  • Manager, Global Site Contracts, Home Based

    hace 4 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Seeking Manager, Global Site Contracts located in the LATAM region. Global experience in the U.S. required and CRO background preferred: **BASIC FUNCTIONS**: Responsible for providing day-to-day supervision and support to the Site Contract Associates and Administrators. Provide customer-focused leadership in the execution of operational strategy and...

  • Clinical Trial Site Engagement Sr Manager

    hace 3 semanas

    Buenos Aires, Argentina Amgen A tiempo completo

    Career Category Clinical **Job Description**: Clinical Trial Site Engagement Sr Manager Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets....

  • Clinical Trial Site Engagement Sr Manager

    hace 3 semanas

    Buenos Aires, Argentina Amgen A tiempo completo

    Clinical Trial Site Engagement Sr Manager Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets. Maintains an effective collaborative partnership...

  • Manager, Global Site Contracts, Home Based

    hace 4 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Seeking Manager, Global Site Contracts located in the LATAM region. Global experience in the U.S. required and CRO background preferred: BASIC FUNCTIONS: Responsible for providing day-to-day supervision and support to the Site Contract Associates and Administrators. Provide customer-focused leadership in the execution of operational strategy and management...

  • Manager, Global Site Contracts, Home Based

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Seeking Manager, Global Site Contracts located in the LATAM region. Global experience in the U.S.required and CRO background preferred:BASIC FUNCTIONS:Responsible for providing day-to-day supervision and support to the Site Contract Associates and Administrators. Provide customer-focused leadership in the execution of operational strategy and management of...

  • Assoc. Site Activation Manager

    hace 1 mes

    Buenos Aires, Argentina IQVIA A tiempo completo

    Associate Site Activation Manager – Sponsor Dedicated Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work and resources. You will: Oversee the execution of Site Activation and Maintenance...

  • Sr. Site Contracts Associate/site Contracts

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    External Job Description IQVIA Biotech is seeking a Senior Site Contracts Associate or Site Contracts Associate located in Argentina: **BASIC FUNCTION**: To manage the review and negotiation of contracts with Investigators participating in clinical research on behalf of pharmaceutical Sponsors. **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**: -...

  • Site Activation Coordinator

    hace 6 días

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Site Activation Coordinator** **Job Overview** Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance...

  • Site Merchandising Manager

    hace 2 semanas

    Buenos Aires, Argentina Italic A tiempo completo

    Italic is creating a world of luxury without labels. We believe that luxury today is exclusionary and all about marketing that hurts its customers and manufacturers. Our mission is to create a new model that enables manufacturers to bypass the legacy luxury supply chain and deliver luxury goods with equivalent or better quality directly to consumers. Our...