Job Description
Requirements:
- 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.
Responsibilities:
- Onsite monitoring may also be required.
- Minimum of college degree in a relevant discipline.
- Bachelor's degree in relevant scientific discipline preferred.
- Oncology experience highly preferred.
- MUST have experience with data review and patient profile review.
Strongly Preferred:
- 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. Also, want to see experience in phase 3 global study trials in multifunctional areas.
Qualifications
Oncology
Additional Information
All your information will be kept confidential according to EEO guidelines.
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