TRABAJO STUDY START UP REGULATORY

Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst...

Perform start up and site activation activities according to applicable regulations, sops and work instructions... prepare site regulatory documents, reviewing for...

· regulatory compliance (change control, post-approval activities, etc... )· interactions with key business partners and regulatory authorities· launch or supply...

Support study team and provide study metrics / reports during the study, audits and regulatory inspections... start date must be by 1st august...

The lab forms part of international consortia focused on advancing research in regulatory genomics, single cell genomics, and human genetics...

The sal will have a comprehensive knowledge of managing and coordinating study start up activities globally... partner and co-ordinate across teams responsible for...

Leads/contributes to the preparation of delegated study documents (e... informed consent form, master clinical study agreement etc), and external service provider...

Supports the completion of top tool and follows up with study team to ensure any identified actions are closed...   supports the completion of ir tool and follows...

\u oversee the execution of start up (including pre-award through site activation) and\/or lifecycle maintenance for assigned projects in accordance with the agreed...

regulatory compliance: ensure adherence to global regulatory standards (e... regulatory expertise: comprehensive understanding of relevant regulatory guidelines...

Lead rwd study from start to completion... understanding of regulatory guidelines for diagnostics/pharma... who you are an expert in rwd study design and analysis...

  the role   accountable for the delivery and quality of site level activities in phase i-iiib clinical development studies; act as link between clinical...