Study Start-up Leader (Multiple European Locations)

Confidencial

Cajamarca, Peru

The Study Start-up Leader is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations, Core/Site document collection/ approval, ICF customization/approval, EC and RA/ MoH submissions, SIV scheduling and activation requirements.. The Senior Study Start-Up Leader, is accountable as noted above including:

- Acting as study-level program lead, such as managing multiple protocol delivery for a Sponsor or asset development.Acting as an Enterprise or Biotech level lead and provide expert level knowledge on agreed partnership process.Additional responsibilities may include:

- Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance.. Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC & RA/ MoH... More Detail

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