Bayside Solutions ยท 15 hours ago
ESR (IST) Contract Manager
Bayside Solutions is seeking a highly motivated and detail-oriented ESR (IST) Contract Manager to manage all aspects of Expanded Sponsored Research contracts. The role involves negotiating contracts and budgets, ensuring compliance with regulatory standards, and overseeing investigator contracts and budgets while maintaining tracking systems and processing payments.
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Responsibilities
Develop clinical trial budgets according to protocol specifications
Independently manage clinical trial contract/budget negotiations with sites
Maintain a tracking system of all ESR(IST) agreements, issues, and communications with internal and external sources regarding contract and budget status
Review and negotiate investigator-prepared budgets for FMV compliance
Develop management reports to support budgeting and forecasting
Maintain internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary
Help foster good relationships with clinical investigators
Responsible for reconciliations
Participate in team meetings
Ensure compliance with policies and procedures
Contract amendments, and is responsible for developing work instructions, internal and external training, managing workload, and preparing and monitoring tracking systems
Qualification
Required
BS/BA degree in a related discipline and a minimum of seven years of related experience; or
Develop clinical trial budgets according to protocol specifications
Independently manage clinical trial contract/budget negotiations with sites
Maintain a tracking system of all ESR(IST) agreements, issues, and communications with internal and external sources regarding contract and budget status
Review and negotiate investigator-prepared budgets for FMV compliance
Develop management reports to support budgeting and forecasting
Maintain internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary
Help foster good relationships with clinical investigators
Responsible for reconciliations
Participate in team meetings
Ensure compliance with policies and procedures
Contract amendments, and is responsible for developing work instructions, internal and external training, managing workload, and preparing and monitoring tracking systems
Preferred
Strong Excel knowledge required; GrantPlan experience
Apply strong analytical and business communication skills
Ability to work effectively in a team/matrix environment
Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results
Oncology experience
Biotech/pharma experience a plus
CMS experience
Smartsheet experience
Strong organization skills with knowledge in creating/managing spreadsheets