13 feb
Allucent
Nuevo Casas Grandes
.At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Operations Manager (COM) to join our A-team (hybrid*/remote).
As a COM at Allucent, you will provide leadership, mentorship; training and career development for assigned Clinical Research Associates (CRAs), Local Site Activation Staff (LSA Staff) and Local Clinical Trial Assistants (LCTAs) to assure the objectives of Allucent and the sponsor are met.
The COM will provide guidance to ensure that staff fulfils responsibilities, to the company and the client,
in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
**In this role your key tasks will include**:- Manages the day-to-day functional and organizational activities of CRAs, LSA Staff and LCTAs- Is responsible for resourcing of assigned staff (Monthly Allocation Form completion)- Oversees and manages the assigned staff workload- Provides leadership, mentorship and career development for the assigned staff, including monitoring performance and identifying training needs- Reviews the budgeted and recorded hours to ensure they are within acceptable working limits for active studies for the assigned staff- Assists assigned staff in managing time and tasks to adhere to study budget and timelines- Provides guidance to ensure that assigned staff fulfils responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines,
FDA regulations and local regulatory bodies- Liaises with Project Management department to ensure CRAs are fulfilling monitoring requirements and meeting project and client timelines; attends assigned project team calls as needed to support the clinical deliverables of the project, and project team member transition meetings- Liaises with Site Activation department to ensure LSA staff is fulfilling submissions requirements, meeting project and client timelines; attends assigned project team calls as needed to support the clinical deliverables of the project, and project team member transition meetings- Liaises with Trial Master File Management department to ensure LCTAs are fulfilling filing requirements, meeting project and client timelines; attends assigned project team calls as needed to support the clinical deliverables of the project, and project team member transition meetings- Updates Country Operating & Regulatory Requirements (CORR)
as required- Collaborates with Project Management department, with Medical Affairs & Pharmacovigilance department, with Quality Assurance and Compliance department- Conducts performance reviews of assigned staff
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.