Senior Clinical Research Manager

Há 4 dias

Buenos Aires, Brasil beBeeClinical Tempo inteiro $1.750.000 - $2.425.000
Job Title: Clinical Trial Manager II

We are seeking an experienced and skilled Clinical Trial Manager II to join our team. This is a key role that will be responsible for the operational management and oversight of clinical investigative sites as well as clinical monitoring deliverables of clinical trials.

This is a home-based position with the opportunity to work with brilliant and driven colleagues in a stimulating work environment. Our company values collaboration, innovation, reliability, and responsiveness.

In this role, you will have the opportunity to build professional relationships with your colleagues at all levels, manage the clinical monitoring portion of clinical projects, and develop your skills in dermatology and rheumatology.

Key Responsibilities:
  • Ensure that clinical monitoring activities are performed to the sponsor's satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements;
  • Identify quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports, and follow-up letters, quality control visits, and quality assurance audit findings;
  • Serve as a point of contact for CRAs and Lead CRAs for assigned projects;
  • Provide mentoring/oversight of CRAs and Lead CRAs;
  • Perform site visit report review for assigned projects and track site visit report metrics to ensure compliance;
  • Contribute to the development of the Clinical Monitoring Plan;
  • Prepare and conduct project-specific training for the CRAs;
  • Develop the annotated site visit reports and monitoring tools such as source data verification worksheets;
  • Conduct quality control visits with CRAs;
  • Coordinate and lead CRA meetings;
  • Perform co-monitoring visits with CRAs;
  • May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs) requests for information (RFIs)).
Requirements:
  • At least 8 years of clinical research experience including prior monitoring experience and at least 2 years of experience acting in a Lead CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry;
Skills and Qualifications:
  • Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
  • Excellent mastery of Microsoft Office suite (Word, Excel, PowerPoint);
  • Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites, and sponsors;
  • Excellent leadership, organizational, time management, and multi-tasking skills;
  • Excellent judgement and problem-solving skills;
  • Occasional travel (up to 10% of the time), including some travel outside of the country once possible;
  • Fluent in English (excellent oral and written);
  • Experience in a CRO and in dermatology an asset.
Benefits:
  • Home-based position;
  • Ongoing learning and development.
About Us:

We are committed to providing equitable treatment and equal opportunity to all individuals. We offer a stimulating work environment and attractive advancement opportunities.

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