TRABAJO VIRTUAL TRIALS CLINICAL CONCIERGE

clinical input to (s)nda/(s)bla)... implement clinical r&d policies, sops and related directives... they share responsibility with clinical operations team members...

clinical input to (s)nda/(s)bla)... possesses detailed knowledge of good clinical practice (gcp) and other regulations governing clinical research...

clinical input to nda/bla)... prepare and provide input to clinical study reports (csrs) and clinical portions of regulatory documents (e...

) outside parties external: • clinical investigator sites • commercial suppliers • clinical research organizations (when applicable)... provide support to the clinical...

Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing...

Preferred: cross-functional experience in clinical research (e... monitoring, data management, clinical quality assurance, study management) experience with risk...

Preferred: cross-functional experience in clinical research (e... monitoring, data management, clinical quality assurance, study management) experience with risk...

Further scope includes working with relevant virtual trials support teams such as tier 2 and study concierge for concerns that require escalation...

Demonstrate knowledge of product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management...

But not limited to aidinc selling process •              actively participate in ongoing and required...