System Admin - Security in New York, NY

Primary Job Function

• Responsible for the review, approval, start-up, maintenance and close-out procedures for IIS proposals and
• Affiliate-sponsored studies (i.e. PMOS). Responsible for the overall tracking and maintenance of the Insights and IMPACT
• Databases,reporting of study information and metrics. Aware of both internal and external business environments and their impact on
• studies. Escalates performance issues to management and System Administration

Core Job Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Coordinate activities for the review and approval of all IIS and affiliate studies within assigned area(s) of responsibility (e.g.Therapeutic Area).
• Coordinate study activities such as contract preparation and drug release to ensure on time execution of studies.
• Manage study completion activities for assigned studies to include timely study approval, contract execution, drug ship and activities of other contributing functional areas.
• Coordinate activities that are necessary for study start up and review or study results/publications.
• Review of all IIS and affiliate study proposals to ensure adherence to SOPs and compliance expectations.
• Responsible for accurate assessment of relevant study type (PMOS, retrospective chart review, disease state study) to ensure appropriate processes are followed. Ability to independently assess study type with minimal direction.
• Manage study completion activities for assigned studies to include timely study approval, contract execution, drug ship and activities of other contributing functional areas. Coordinate activities that are necessary for study start up and review or study results/publications. Subject Matter Expert (SME) for processing of study submissions via Insights tool and processes related to external research proposa/affiliate study approval via Scientific Review Committee (SRC).
• Review of US IIS study budgets for Fair Market Value. 
• Review of invoices against contract terms for approval of payments. For studies with GPT funding,request of R/OSS for assigned studies.
• Ensure final reconciliation of study and site payments and approval of R/OSS closure.

Position Accountability / Scope / System 36

• Individual Contributor. Organization Interaction: Daily interaction with affiliates, therapeutic area physicians, scientific review committee members and peers in multiple cross-functional areas. Reports to Associate Director, Medical Research Support. Financial: Assessment of Fair Market Value for all US IIS proposals.
• Review of external budgets for adherence to company policies.
• Review of invoices for approval of payments against contract milestones.
• Risk/Decision Making: Incorrect or inaccurate decisions will impact affiliate medical budget plans, key external relationships with investigators and may impact affiliate research success and regulatory filings/approvals. Accountable to Clinical Medical Affairs.
• Requires some oversight and guidance.

Minimum Education

• Bachelor's degree or equivalent in science, technical, or health-related field required. Prior project management and/or grant management experience desirable

Minimum Experience / Training Required

• 6-8 years experience in Pharma industry with an emphasis on the business (contracting, outsourcing, finance) and/or technical (chemistry, biology, clinical) aspects.
• Must have demonstrated ability to independently manage multiple projects at various stages. Proven track record of successful projects (delivered on time, within budget, and with high quality).
• sanofi exelon pfizer

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