TRABAJO STUDY START UP REGULATORY

Sr manager, study start up icon plc is a world-leading healthcare intelligence and clinical research organization... we are currently seeking a senior manager, study...

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

What you will be doing: support the day-to-day operations of assigned activities within ssu to ensure completion per established goals and objectives in compliance...

Reports study progress/update to the global study associate director/ global study team including smm lead... ensures timely submission of application/documents...

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

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...

You enjoy collaborating with study teams, clinical sites, and regulatory bodies to ensure trials start on time and in full compliance... this role is partly office-based...

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...

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...

• ensure that the study management team (smt) operates in a constant state of inspection-readiness... • lead the study management team including providing updates...

\u ensure that the study management team (smt) operates in a constant state of inspection-readiness... \u lead the study management team including providing updates...

)execute the study medical review related to trial... our benefits! ⏰ flexible start time from monday to friday (full-time)... represent the company via presentations...

Develop key study quality metrics (e... lead multi-disciplinary trial teams, including the study team meetings... ) and determine appropriate action in conjunction...

Develop, review and execute vendor statement of work (“sow”), submit requisitions in icon’s purchasing system ensure that study materials are saved to the...

\u develop integrated study management plans with the core project team... req \u knowledge of clinical trials - knowledge of clinical trial conduct, and skill in...

About the role major accountabilities: facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management...

• develop integrated study management plans with the core project team... • collaborate with other functional groups within the company where necessary to support...