| Company: | Ferring Pharmaceuticals, Inc.
Parsippany, NJ |
| Job Location: |
Parsippany - Morris County
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| Employment Type: | Full Time |
| Department: | FIPCUS (Clinical R&D) |
Description: |
SUMMARY:
Heading the Operations Team
Management of clinical operations for approximately 13 clinical programs (Global and Local)
Work closely with Therapeutic Area Heads to ensure optimal project staffing and execution
Works closely with President of FIPCUS to ensure alignment of priorities, appropriate operations staffing and resources, training, and strategic planning for future growth
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Duties: |
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage the Operations Team in collaboration with the three Therapeutic Area Heads
Develop the Operations Team as a team and as individuals
Ensure clinical studies are conducted according to ICH standards and competent authorities requirements
Ensuring inspection readiness of the Team and the studies
Budget/ Forecast for Internal and external costs - input and review
Ensure studies are conducted to timelines
Overview that study budgets/forecasts are kept and updated if necessary
Involvement in eCTD submission activities
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Qualifications: |
QUALIFICATION REQUIREMENTS:
Education: Minimum 4 year university (B.S.) or R.N degree with preferred advanced degree focused on life sciences
Experience: Min. 5 years of experience with clinical trials holding a position as Clinical Research Manager, Manager Clinical Operations, Resource Manager, Clinical Study Manager or Clinical Project Manager
Computer Skills: Candidate is super user of the MS Office package – especially MS Access, MS Excel and MS Project. |
