Clinical Trial Manager, CSCP

Clinical Trial Manager, CSCP
<br>Manages the development, negotiation, and acceptance of clinical trial Statements of Work and budgets with external clinical service providers. This effort includes development and maintenance of RFP and budget templates; development and administration of study-specific RFPs and Change Orders; development and negotiation of study-specific detailed Statements of Work (SOW), Transfer of Obligations, budgets, deliverables, timelines, metrics, acceptance criteria and payment schedules. Supports strategic sourcing and supplier relationship management initiatives within Clinical Development. Reviews and approves all budget-related contractual documents to ensure compliance with customer specifications, company policies and governmental regulations. Supports the development and maintenance of clinical trial budgets and forecasts. Ensures on-time payments to external service providers.<br><br>Duties/Responsibilities:<br><br>*<br>Manages the overall contract and budget development and negotiation process with External Service Provider(including Change Orders)<br><br>*<br>Supports strategic sourcing initiatives<br><br>*<br>Supports supplier relationship management initiatives<br><br>*<br>Generates clinical trial cost estimates<br><br>*<br>Performs benchmarking of external costs to ensure that budgets are within Fair Market Value (FMV)<br><br>*<br>Ensures on-time payments to external service providers<br><br>Independent team member performing highly technical or specialized work. Applies judgment and professional expertise in new situations. Responsible for managing core project(s). Works as an independent project team member or may act as a manager of one or more junior staff. Develops and maintains interdisciplinary relationships with the project team. Recognized for technical expertise within a department or functional area.<br><br>Detailed knowledge of regulations and guidelines. Oversees and approves numerous projects. Impacts the results of a department or project influencing both the tactical work and the direction of future endeavors of the group. Demonstrates full technical independence. Integrates results from other projects as well as external sources to enhance core operations and identify new opportunities. Demonstrated ability to write and present clearly. Key contributor to project team and group discussions. Oversees the activities of external service providers.<br><br>Special Training:<br><br>*<br>Knowledge and understanding of the contract development and negotiation process<br><br>*<br>Knowledge of clinical development<br><br>*<br>Knowledge of medical terminology<br><br>*<br>Knowledge of investigator and/or Contract Research Organization (CRO) payment<br>processes is desirable<br><br>*<br>Strong knowledge of MS Word, Excel, and PowerPoint<br><br>*<br>Knowledge of SAP<br><br>*<br>Knowledge of category management methodology and tools<br><br>*<br>Knowledge of industry cost benchmarking tools<br><br>*<br>Knowledge of clinical trial budgeting and forecastings<br><br>Skills/Ability:<br><br>* Ability to work independently and exhibit initiative<br><br>* Strong verbal and written communication skills to interact in a team oriented environment<br><br>* Strong negotiation skills<br><br>* Strong time management skills<br><br>Experience:<br><br>A minimum of 5 years of relevant work experience in contract management or strategic sourcing within the biopharmaceutical or CRO industry. 2 years of clinical research experience preferred.

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