Clinical Study Manager

Medical Affairs - Global Oncology

• Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments.

• Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.).

• Participate in development of protocol, case report form, CRF guidelines and other study documents.

• Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal.

• Ensure the training of CROs/investigators on protocol, regulatory, Eisai SOPs and data issues. Reviews and approves monitoring reports and ensures tracking of ongoing site issues. On-site Monitoring

• Minimum of college degree in a relevant discipline.

• Bachelor's degree in relevant scientific discipline preferred.

• CANDIDATES MUST HAVE MIN 3-5 years in-house in pharma company. Not just 3-5 years in CRO or onsite monitoring. We want to see associate in-house large pharma.

• Want to see experience in phase 1-3 global study trials in multifunctional areas.

• MUST HAVE experience in reviewing patient data and patient profiles.

• **Oncology Experience Highly Preferred.**

Best Regards,

Sneha Shrivastava

973-967-3348