Clinical Study Manager

Job Description

1. Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP). 2. Lead cross functional Study Execution Team, including functions, Strategic Partners and other vendors to ensure study goals are met, on time and within budget. Includes leading and organizing cross functional study team meetings. 3. Ensure appropriate regional input for global or multinational studies prior to decision making. Responsible for communication of study information to Clinical Operations regions. 4. Contributes to protocol synopsis development and to Clinical Study Plan development, including Clinical Operations feasibility assessments. 5. Leads the cross functional protocol development process, including responsibility for any protocol amendments or administrative changes. 6. Management of Strategic Partners, including setting expectations, training, CRO Oversight process, Task Orders, Change Orders, invoice approval and financial reconciliation process for assigned study. Responsible as first point of contact for Issue Management process for assigned study. (Range: $500,000 (e.g. less complex Phase 1) to $200 million(large complex outcomes studies)) 7. Leads the evaluation and selection of required vendors, including contract and budget negotiation, invoice approval and financial reconciliation process. Responsible for day-to-day management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management. 8. Provides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. 9. Escalates medical issues to appropriate medical personnel. 10. Provides regular budget updates to Clinical Program Manager, or Finance when required. 11 identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning. 12. Able to assist Clinical Program Manager and may represent Clinical Program Manager, when necessary 13. Participates in Clinical Operations or cross functional initiatives

Qualifications

Education: Bachelors Degree, RN, or international equivalent required, Life Sciences preferred.

Additional Information

Manisha A.Jathar Integrated Resources, Inc IT REHAB CLINICAL NURSING Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 & 2013 (7th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70 Direct: (732) 429-1850 Tel: (732) 549 2030 x 132