Senior Quality Analyst at Leonardo DRS focuses on quality control and compliance audits. Evaluating processes and ensuring adherence to quality standards for defense technology solutions.
About the role
- Site Grant Analyst resolving global site budgeting issues for a leading biopharmaceutical company. Collaborating on budget negotiations and developing investigator budget templates as a subject matter expert.
Responsibilities
- 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.
- 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.
- 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.
Requirements
- BS degree in life sciences, a health related field, or equivalent combination of education and experience.
- Strong 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.
- Strong 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.
- Attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines.
- Strong leadership skills; ability to teach/mentor team members.
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
- Flexible paid time off (PTO) and sick time
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