Cra Manager

hace 2 semanas

Santiago de Chile MSD A tiempo completo

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.

As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.

The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The role will collaborate with country PLMs to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

**Responsibilities include, but are not limited to**:

- Work allocation, staff development and performance appraisal.
- Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
- Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
- Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.
- Attend local Investigator Meetings if requested to.
- Interface with GCTO partners on clinical trial execution.
- Escalates site performance issues to CRM and Clinical Research Director CRD.
- People and Resource Management:

- Manage CRA - career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.
- Support and resolve escalation of issues from CRAs.
- Liaise with local HR and finance functions as required.
- Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.
- Provides training, support and mentoring to the CRA to ensure continuous development.
- Ensures CRA compliance to corporate policies, procedures and quality standards

**Experience Requirements**:
Required:

- Minimum of 5 years´ experience within Clinical Research
- Minimum of 3 years’ experience as CRA monitoring clinical trials
- Line management experience preferred or at the minimum team leader experience

**Educational Requirements**:
Required:

- Bachelor’s degree in Science

Preferred:

- Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
11/18/2024

**Requisition ID**:R319306

  • Associate Director Clinical Research

    hace 1 semana

    Santiago de Chile AstraZeneca A tiempo completo

    Objetivo del Puesto: El Director Asociado de Investigación Clínica (ADCR) es responsable de entregar la parte comprometida de todos los estudios clínicos de intervención bajo su supervisión de acuerdo con los recursos acordados y los cronogramas que cumplan con los Documentos de procedimiento de AZ, las pautas internacionales como ICH-GCP y las...

  • Manager, Clinical Operations

    hace 1 semana

    Santiago de Chile Icon plc A tiempo completo

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

  • Manager, Clinical Operations

    hace 2 semanas

    Santiago de Chile ICON A tiempo completo

    As a **Clinical Operations Manager** you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s...

  • Cra I

    hace 4 días

    Santiago de Chile Labcorp A tiempo completo

    Labcorp 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 Chile. Role description: - Ensure the study staff who will conduct the protocol have...

  • Assoc. Spclst, Clinical Research

    hace 1 semana

    Santiago de Chile MSD A tiempo completo

    Associate Clinical Research Associate With 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...

  • Clinical Operations Manager

    hace 1 semana

    Santiago de Chile MSD A tiempo completo

    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, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...

  • Clinical Operations Manager

    hace 6 días

    Santiago de Chile MSD A tiempo completo

    The Clinical Operations Manager role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is...

  • Engineering Manager

    hace 2 semanas

    Santiago, Chile Canonical A tiempo completo

    Engineering Manager - Security Standards and Hardening Join or sign in to find your next job Join to apply for the Engineering Manager - Security Standards and Hardening role at Canonical Engineering Manager - Security Standards and Hardening 3 days ago Be among the first 25 applicants Join to apply for the Engineering Manager - Security Standards and...

  • Clinical Research Associate

    hace 4 días

    Santiago de Chile MSD A tiempo completo

    **Job Description**: Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company "“ one that is ready to help create a healthier future for all of us. Responsibilities include, but not limited to: - Acts as primary site...

  • Sr. Clinical Trial Manager

    hace 7 días

    , Región Metropolitana de Santiago, Chile Syneos Health A tiempo completo

    Sr. Clinical Trial Manager - Mexico Join to apply for the Sr. Clinical Trial Manager - Mexico role at Syneos Health. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market...