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Contract Specialist - Italy (12-Month Fixed-term Contract)
Eingestellt von PPD
Gesuchte Skills: Client
Projektbeschreibung
PPD are currently recruiting for a Contract Specialist to be based from our Milan office, on a 12-month fixed-term contract.
The role will be responsible for reviewing PPD and/or client SOA templates for compliance with local legislation and practices, adapting them as necessary to client and investigational site requirements. The role involves liaison with the Cambridge contract/legal team, the Clinical Managers and other departments as required. The CCS will enter and maintain trial status information relating to start-up activities onto tracking databases, eg CASCADE, and maintain a working knowledge of ICH/GCP, SOPs, WPDs and applicable client SOPs. The CCS will ensure good communication within the start up team, and establish effective relationships with sites.
Effective budget negotiation with site personnel is expected, in collaboration with the project management team. The role will be responsible for revising SOAs and financial agreements for the duration of the project in collaboration with the project management team, and ensuring the local country study files and filing processes relevant to contracts and finance are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. In addition to this, the CCS will be responsible for facilitating and responding to company, client and regulatory audits as required.
Required Education and Experience:
-Legal or life science degree and/or equivalent by experience
-Basic experience in contract negotiation and contract drafting is desired as well as good working knowledge of GCP, SOPs, WPDs and applicable client SOPs.
-Basic awareness of legal and ethical framework, ICH GCP and country regulations and requirements.
The role will be responsible for reviewing PPD and/or client SOA templates for compliance with local legislation and practices, adapting them as necessary to client and investigational site requirements. The role involves liaison with the Cambridge contract/legal team, the Clinical Managers and other departments as required. The CCS will enter and maintain trial status information relating to start-up activities onto tracking databases, eg CASCADE, and maintain a working knowledge of ICH/GCP, SOPs, WPDs and applicable client SOPs. The CCS will ensure good communication within the start up team, and establish effective relationships with sites.
Effective budget negotiation with site personnel is expected, in collaboration with the project management team. The role will be responsible for revising SOAs and financial agreements for the duration of the project in collaboration with the project management team, and ensuring the local country study files and filing processes relevant to contracts and finance are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. In addition to this, the CCS will be responsible for facilitating and responding to company, client and regulatory audits as required.
Required Education and Experience:
-Legal or life science degree and/or equivalent by experience
-Basic experience in contract negotiation and contract drafting is desired as well as good working knowledge of GCP, SOPs, WPDs and applicable client SOPs.
-Basic awareness of legal and ethical framework, ICH GCP and country regulations and requirements.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung