Cra Line Manager
hace 1 semana
CRA Line Manager
**Category**:Clinical Development**Location**:Ciudad de México, Ciudad de México, MX-
**Position Description**
As a CRA Line Manager at Novo Nordisk, you will:
- Manage a team of CRAs to ensure compliance with ICH/GCP, SOPs, and local regulations.
- Oversee resource allocation and monitor staff utilization for clinical projects in the medium and long term.
- Build rapport with monitors, oversee their workload, and coordinate CRAs in alignment with the clinical area.
- Conduct performance and competencies appraisals, provide training, coaching, and mentoring to the team, and develop and train staff focusing on individual CRA needs.
- Hire, onboard, and integrate new CRAs, and act as the first point of contact for insourced monitors and oversee CRO contracts to ensure compliance.
- Communicate regularly with TA Lead, Clinical Operations Head, and other relevant stakeholders about CRAs' performance and potential issues, manage the quality of assigned staff through regular review of quality metrics and follow-up, and promote behavior changes aimed at improving performance and competence acquisition while aligning employees to departmental standards and new processes, ensuring compliance with NN Way and Business Ethics.
**Required Qualifications**- University Degree, preferred in Life Sciences or related like Pharmacobiologist Chemist, Pharmaceutical Engineer, Biologist, etc.
- Minimum 8 years of demonstrated proficiency in Clinical Research, with the technical skills and knowledge to ensure compliance with ICH/GCP, SOPs, and local regulations.
- Desirable: 1.5 years of experience as a people manager/coaching a team to work towards common goals, provide constructive feedback, and develop talent.
- Availability to travel 30-40% of the time.
- Advanced English proficiency.
**About the department**
The CMRQ department, supporting the obesity team, is responsible for running all clinical development activities from initial planning of clinical trials to authority submission. We investigate patients' reactions to new drugs, compare new drugs to existing products, and run a set of pre-specified trials in human beings. Our team provides biostatistics and programming, clinical reporting, data management, epidemiology/real-world evidence, and clinical pharmacology resources to all development projects. With a hybrid work model, you will have the flexibility to work both remotely and on-site, ensuring a balanced and productive work life.**Working at Novo Nordisk**
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.**Contact**Deadline**
- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
-
Ssu Cra
hace 7 días
Ciudad de México Novartis A tiempo completoSite relationship management role to ensure sustainable trial start-up at Site.The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local...
-
cra 1
hace 16 horas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functions• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...
-
Cra Ii or Sr Cra Oncology
hace 3 semanas
Edo. de México Syneos Health Clinical A tiempo completo**Description****CRA II or Sr CRA oncology & on site experience Home Based Mexico****CDMX/Aguascalientes/Oaxaca/Guadalajara - availability to travel required**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...
-
Cra I
hace 7 días
Ciudad de México Fortrea A tiempo completoLabcorp Drug Development is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career? We are currently recruiting for a Clinical Research Associate I in Mexico. Role description: - Ensure the study staff who will conduct the protocol have...
-
Clinical Project Manager
hace 2 días
Ciudad de México Novartis A tiempo completoThe SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements. The CPM is the single point of contact and study team lead,...
-
Sr Cra I
hace 2 semanas
Edo. de México Syneos Health Clinical A tiempo completo**Description****Senior Clinical Research Associate I**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...
-
Sr. or Clinical Trial Manager Ii, Oncology, Mexico
hace 12 horas
Ciudad de México Novasyte A tiempo completoIQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support. Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager. Previous clinical trial management and CRO experience preferred. Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell & Gene...
-
Associate Clinical Research Associate
hace 2 días
Ciudad de México MSD A tiempo completoWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring...
-
Clinical Research Associate
hace 2 semanas
Ciudad de México MSD A tiempo completoThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally.Acts as primary site...
-
Clinical Research Associate
hace 2 semanas
Ciudad de México MSD A tiempo completo**Job Description**:The role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.Acts...