Clinical Study Manager

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

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.

Qualifications

• **Oncology Experience Highly Preferred.**

Additional Information

Best Regards,

Sneha Shrivastava

973-967-3348