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Clinical Trial Manager, Site Manager, Clinical Trial Director, Director of Clinical Trial 70 views

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Job Opening:  Clinical Trial Manager, Site Manager, Clinical Trial Director, Director of Clinical Trial

Location:  Encino, California

Description:  The Clinical Research Site Manager works closely with the PI and Sub-Is and is responsible for the successful planning, management, oversight and execution of clinical trials at ERC. The span of activities is broad covering clinical activities in study start-up, initiation and early development phases and will include project management, execution, strategic planning, team building and team training. This CRSM needs to be an excellent communicator and be able to work well with teams.

The CRSM will be involved in the daily operations of clinical trials. S/he must have an expert and comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards. The CRSM will be responsible for successful execution of clinical trials according to regulatory guidelines. S/he must facilitate effective internal and external relationships.

Duties:

1.  Manage research team consisting of 8-12 people. The research team includes: CRCs, Research Assistants, QC personnel, Sub-Is and PI.
2.  Oversee all day-to-day tasks relating to 8-20 ongoing trials
3.  Recruit new studies and manage study start up, including budgeting, negotiating, and contracts
4.  Manage correspondence with monitors, sponsors, and vendors to ensure all contractual obligations are met.
5.  Review and manage all aspects of ongoing regulatory documents
6.  Work closely with PI/Sub-I to ensure trials are run successfully

7.  Prepare the design, format and content and/or provide technical expertise for the development of essential clinical documents (e.g. source documents, SOPs, monitoring plans)

Requirements:

1.  Bachelor / Master degree in life sciences, nursing, or a related field of study
2.  Vast knowledge of GCPs, ICH guidelines, FDA regulations.
3.  Vast knowledge of/ experience in regulatory affairs
4.  Experience with sponsor audits / FDA audits
5.  Experience overseeing / managing project finances, invoices and forecasting.
6.  Strong understanding of clinical research and medical terminology
7.  Experience as a Clinical Research Coordinator

8.  Minimum 3 years as clinical trial manager or similar position

Compensation:  $80,000-$120,000 plus excellent benefits and bonuses

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