...combination of education, training and experience.
• Advanced knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Knowledge of clinical research...
...excellent knowledge of the clinical operation processes and vendor management
~ Excellent knowledge of GxP and ICH regulations
~ Very good knowledge of clinical trial design and mapping to supplier requirements
~ User Acceptance testing for eCOA and IRT
~ Site...
...role you will execute routine tests per standard operating procedures on raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory.
Primary Responsibilities:
Performs routine testing of samples submitted to...
...Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance...
...skills with ability to challenge.
Excellent interpersonal skills and strong team player.
Possess strong analytical skills with good problem solving and leadership skills.
Proven ability to work on multiple projects balancing competing priorities.
Ability to...
...global environment / organization is preferred
Solid analytical, organizational, and project management skills and leadership
Very good interpersonal skills, active listener, organizational awareness and relationship building
Very good communicator, both verbal and...