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Job Title:     Local Trial Manager III
Job Location:  NJ: RARITAN
Pay Rate:      Open
Job Length:    over 1 year (contract)
Start Date:    2012-11-09

Company Name:  Axelon Services Corporation
Contact:       Beatrice Miles
Phone:         212-306-0199
Fax:           212-306-0191

Description:   Title:  Local Trial  III        Description:     ROLE: SR. SITE MANAGER - ONCOLOGY - ESTIMATED 70-80% TRAVEL     REGIONALLY BASED   POSITION NEEDED FOR MONITORING IN NEW YORK CITY AREA.         GCO Trial Coordination Site Management Department   Janssen R&D     Experience/Education: A minimum of a BA/BS degree is required. Degree in a health or science major. Minimum 2 years oncology monitoring experience; 5 years is preferred. Estimated 70-80% travel. Minimum four - six years pharmaceutical experience is required. Should have solid understanding of the drug development process including GCP and FDA Code of Federal Regulations. Solid communication and computer skills required.     Responsibilities include site recruitment, patient recruitment and retention planning, site initiation, monitoring and close-out. Ensures study related activities are in compliance with all GCO SOPs, policies and regulatory requirements from start-up through data-base lock. Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. Serves as primary point of contact and liaison between investigational site staff and GCO study team once site is initiated. Represents functional area in divisional/company-wide process initiatives. Reports to Functional . Internal Interfaces: IDAs/LTMs/GTMs/Clinical Team contacts including Study Responsible Physician as needed. External interfaces: Trial Site personnel, vendor representatives and key opinion leaders     1. Participates in Site/Investigator selection process by providing recommendations from local area.     2. Assesses site experience, facility, and EDC capabilities to perform study activities (e.g., EDC, imaging).     3. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.     4. Ensures Visit Reports are written and submitted via eTMF within 5 working days.     5. Ensures site staff resolve data queries, and works with sites to ensure data timelines are met.     6. Maintains accurate and timely data in systems utilized for clinical trial management.     7. Updates site payments in CTMS.     8. Ensures, in collaboration with LTM, the timely and accurate data collection, documentation and communication of site/study progress and issues.     9. Plans, conducts and documents site staff training and monitors site performance. Updates training matrix in SharePoint as necessary and ensures all site personnel training documentation is on file at the site and in the Investigator File.     10. Contributes to site level recruitment strategy and contingency plan in partnership with other functional areas to achieve clinical research targets.     11. Presents/participates in Investigator Meetings as needed.     12. Monitors expiry date of Investigational Product and ensures study supply strategy is adequate.     13. Works with LTM to ensure CAPA is completed for QA site audits     14. Attends regularly scheduled team meetings and trainings.     15. Mentors new hires with supervision.     16. Serves as Lead SM/ SM EDC specialist for a specific trial as needed. In conjunction with LTM, review eCRFs, Completion Guidelines and participate in EDC UAT .     17. Participates in special initiatives as needed.

Please refer to Job code 12-17300 when responding to this ad.

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