EMPREGO CLINICAL TRIALS REGULATORY SUBMISSION

• awareness of applicable clinical research regulatory requirements, i... essential functions • assist clinical research associates (cras) and regulatory and start-up...

Collect, handle and maintain all site-specific regulatory documents as needed... proper handling, accountability and reconciliation of investigational products and...

​ ​ accountabilities:  ​clinical team leadership and project team / clinical team membership leads clinical teams as global clinical lead or represents clinical...

​regional/global regulatory requirements...   applies clinical/medical decision making to clinical development issues... ​contributes to global project and clinical...

Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval manages the device regulatory strategy of high...

Develops clinical tools (e... continuously monitors clinical trials to assess performance and ensure contractual obligations are met...   provides input into preparation...

Maintaining proficiency in broad, regional regulatory requirements... interface with regulatory agencies and distribution partners as needed... knowledge of pc hardware/software...

Ability to manage multiple priorities within various clinical trials... regulatory document collection and review... thorough knowledge of clinical research process...

The clinical data sciences comprises of the clinical data engineering (cde) and clinical data standards... while the clinical data standards provides the standards...

As a pivotal member of the site team, you will be involved with a variety of administrative tasks to support investigators and ensure the smooth running of clinical...

clinical research coordinator, nurse, medical assistant, other medical profession... preparing and maintaining study files, and timely submission of information...

Understanding of clinical trial design and execution... o disease area research o standard of care o results from clinical trials in specific indications...

Years related industry experience in clinical trials (essential)... interpret clinical trial protocols to create and execute an effective clinical trial supply...