Associate Clinical Country
Há 3 dias
Company Description
At Biogen, our mission is clear: we are pioneers in neuroscience. Since our founding in 1978 as one of the world’s first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
Job Description
The Associate Clinical Country and Site Lead will be Biogen’s internal “link” between key areas so the affiliate is always informed about current and planned studies. Also, among other activities, will be responsible for:
- Being our point of contact between functional areas within Biogen to align local study strategies and share development information with the local affiliate;
- Maintaining current awareness/information pertaining to local clinical knowledge of disease areas researched by Biogen, emerging standards of care and trial related needs of clinicians in community;
- Providing global teams with detailed local operational and scientific knowledge that will inform the overall clinical development strategy and ensure that local opportunities and needs are thoughtfully integrated into operational plans;
- Overseeing CRO activities with a country level focus on performance;
- Serving as a site escalation point for investigator concerns, including those related to data integrity or issues which are un-resolved by the CRO;
- Managing investigator and site knowledge/relationships to inform teams of country level capabilities, interests, needs and satisfaction in order to position Biogen as the company partner of choice for clinical trials;
- Leading/supporting required local activities as part of agreed country and site selection process to ensure appropriate input is sought from local treating physicians and other stakeholders;
Qualifications
- Bachelor Degree in Science/Health related courses;
- Experience as Lead CRA (or higher);
- Minimum of 5 years of experience managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors;
- Excellent knowledge of clinical operational activities/challenges across local geography and in regional/global studies/projects;
- Deep understanding of cross functional drug development process and high scientific/clinical knowledge (rare diseases are highly preferred, but we will also evaluate profiles with experience in neuroscience, oncology, cardiology or endocrinology - in this order of preference);
- Background in the pharma sector or CROs;
- Fluent English;
- Availability to travel in Brazil and abroad;
Additional Information
If you believe you are focused, a collaborative decision-maker, with good problem solving and communication skills, and want to join a fast paced environment, **please apply**
-
Senior Regional Clinical Trial Management Associate
1 semana atrás
São Paulo, Brasil BeiGene Tempo inteiroPLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION Language Requirement: Fluency in English and Spanish (previous experience in other Latin America countries is a differentiator) Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology Location: This is a hybrid position with a minimum of 1 day per week in office in Sao...
-
São Paulo, SP, Brasil BeiGene Tempo inteiroPLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION Language Requirement: Fluent English and Portuguese. Spanish is a plus. Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology General Description: - Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical...
-
Clinical Research Associate
4 semanas atrás
São Paulo, Brasil ICON Tempo inteiroAs a (Senior) Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working location : Client office, flexible work from home The Senior Clinical Research Associate manages, monitors, and closes out assigned clinical trial sites, ensuring patient safety,...
-
Clinical Research Associate
2 semanas atrás
São Paulo, Brasil Parexel International Tempo inteiroThe Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to...
-
Clinical Research Associate
1 dia atrás
São Paulo, Brasil Parexel Tempo inteiroWhen our values align, there's no limit to what we can achieve. The Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site...
-
Associate Clinical Research Manager
Há 3 dias
Sao Paulo, Brasil Fortrea Tempo inteiroThe Ass CRM is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations. The position has a significant impact on how a country can deliver...
-
Principal Clinical Research Associate
Há 3 dias
Sao Paulo, -, Brasil CTI Clinical Trial Services Tempo inteiro US$80.000 - US$120.000 por anoPrincipal Clinical Research Associate Please submit your CV in English for Quickest Review Process Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone...
-
Associate Director Clinical Monitoring
Há 5 dias
São Paulo, Brasil CTI Clinical Trial and Consulting Services Tempo inteiro1 day ago Be among the first 25 applicants About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug...
-
Clinical Associate
1 semana atrás
Sao Paulo, Brasil Icon plc Tempo inteiroRecognize, exemplify and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration and excellence in delivery. - As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and...
-
Lead Clinical Research Associate
Há 5 dias
São Paulo, Brasil PSI CRO Tempo inteiroJob Description Coordinates investigator/ site feasibility and identification process, as well as study startup. Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. Manages Monitors in...