Principal Site Grant Manager at Syneos Health managing investigator budgets and collaborating with internal and external stakeholders for effective project management. Ensuring compliance with regulations and company guidelines.
Responsibilities
Establishes, maintains and updates training material for investigator budget team and site contract negotiators.
Actively participates in higher-level discussions about overall company goals, functional objectives in the Business Unit (BU), and specific project aims.
Serves as subject matter expert equipped to help resolve global site budgeting issues, and escalation point within the Company for internal customers to seek assistance.
Proposes site budgeting solutions to issues that may arise during a project or contract/budget life cycle to enhance negotiation strategy and ensure deliverables are met.
Establishes project strategies around investigator budget template development and/or budget negotiation parameters to reflect sponsor's specifications, communications and required processes.
Initiates and introduces creative ideas and solutions.
Develops detailed investigator grant budget estimates and country budget templates according to protocol specifications through currently available software package/resources.
Updates detailed investigator grant budget estimates and country budget templates according to protocol amendment specifications through currently available software package/resources.
Works closely with internal stakeholders to draft, collaborate with Sponsor and harmonize investigator budget templates, investigator budget parameters and payment terms within Company processes.
Ensures investigator budget templates are drafted and updated taking into consideration fair market value and key operational aspects indicated in the relevant operational documents (e.g. protocol, Integrated Site Activation and Maintenance Plan, etc.), as well as in the customer agreement documents at a project and organizational level.
Establishes strong working relationships and collaboration with Sponsor to ensure site budget templates fit into the global strategy set for the program.
Validates investigator grant budget estimates against available internal and external benchmarking data.
Identifies possible investigator budget or process operational risk and proactively works to provide solutions.
Establishes strong working relationships with customer and internal project teams.
Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.
Creates and maintains document status reports, and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.
Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
Researches, compiles and creates necessary information as required in support of obtaining fair market value and developing investigator budget templates.
Identifies best practices, investigates root causes of fundamental issues and problems for projects and recommends solutions.
Recognizes and develops opportunities for continuous process improvement within investigator budget template development, which lead to greater efficiencies and/or leading best practices.
Trains and mentors less experienced staff members on department Standard Operating Procedures (SOPs), processes, tools and templates and ensures quality of teamwork products.
Represents the Company at professional meetings or seminars.
May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.
May identify and lead internal team training and/or process improvement initiatives.
Participates in business development presentations as a subject matter expert in budget development and Fair Market Value (FMV) within the Company.
Performs other work-related duties as assigned.
Minimal travel may be required (up to 25%).
Requirements
BS degree in life sciences, a health related field, or equivalent combination of education and experience
Extensive experience in a CRO/pharmaceutical industry and related clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience
Thorough knowledge of applicable regulations, drug development and clinical project management procedures
Excellent presentation, documentation and interpersonal skills
Proficient in MS Office (Word, Excel and PowerPoint), MS Project, outlook and Internet.
Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment
Above-average attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines
Excellent leadership skills; ability to teach/mentor team members
Ability to coach employees to reach performance objectives
Strong background in issue resolution, meeting customer deliverables and driving best practices at organization or customer portfolio level.
Benefits
Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
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