Lead, Clinical Research Associate
C
CelerionClinical Research
Remote - USFull-TimeLead
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- At least 5 years or more in clinical operations or related discipline either in CRO or Pharmaceutical industry with a minimum of 3 years onsite monitoring experience.
- Required Skills
- GCPPeople Management
Requirements
- Bachelor's degree in a biomedical-related field, life sciences, or equivalent.
- Minimum 5 years of experience in clinical operations within a CRO or pharmaceutical industry.
- Minimum 3 years of onsite monitoring experience.
- Prior people management experience required.
- Profound knowledge of Good Clinical Practice (GCP) and 21 CFR Part 11.
- Excellent oral and written communication skills in English.
- Proven experience performing site visits (SQV, SIV, Routine, Close-out) and managing Trial Master Files.
- High level of organization, analytical skills, and attention to detail.
- Ability to work independently and as part of a team.
- Flexibility and willingness to travel for both planned and impromptu meetings or site visits.
Responsibilities
- Provide direct supervision, line management, and mentorship to a team of CRAs and contractors.
- Manage staff performance, conduct annual appraisals, and define development objectives.
- Assign staff to clinical projects and monitor workloads to ensure optimal resource allocation.
- Oversee the implementation and monitoring of clinical studies to ensure compliance with GCP and regulatory requirements.
- Manage monitoring activities within CTMS, including tracking visits, queries, and issues.
- Review monitoring metrics to evaluate quality trends and adherence to monitoring plans.
- Act as an escalation point for direct reports regarding trouble shooting and CAPA management.
- Participate in sponsor meetings, audits, and inspections as required.
View Full Description & ApplyYou'll be redirected to the employer's site
