Clinical Trial Manager II

2 weeks ago

Romania Indero Full time €60,000 - €80,000 per year
  • You enjoy working with a mid-sized CRO where you can build professional relationships with your colleagues at all levels
  • You bring previous experience in managing the clinical monitoring portion of clinical projects
  • Dermatology and rheumatology are therapeutic areas you enjoy or want to learn more about
RESPONSIBILITIES
  • Ensures 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;
  • Identifies 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. Summarizes findings and establishes action plans to bring corrective actions;
  • Serves as a point of contact for CRAs and Lead CRAs for assigned projects;
  • Provides mentoring/oversight of CRAs and Lead CRAs;
  • Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance;
  • Contributes to the development of the Clinical Monitoring Plan;
  • Prepares and conducts project-specific training for the CRAs;
  • Develops the annotated site visit reports and monitoring tools such as source data verification worksheets;
  • Conducts quality control visits with CRAs;
  • Coordinates and leads CRA meetings;
  • Performs 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)).
Our company:The work environment
  • Flexible work schedule / work schedule :
  • Home-based position
  • Ongoing learning and development

IDEAL PROFILEEducation
  • B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience;
Experience
  • 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;
Knowledge and skills
  • Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
  • Excellent mastery of Microsoft Office suite (Word, Excel, Power Point);
  • 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.

Indero

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