Clinilabs

• Work collaboratively with internal stakeholders (e.g. business development, business unit leadership, budget team) and external stakeholders (e.g. scientific advisors, vendors, consultants) to develop strategies that effectively articulate customer needs critical to generating new business awards. • Conducts qualitative and quantitative research to create customized and compelling business development documents focused on client solutions that highlight company differentiation, innovation and operational strategy. • Produces high quality, customer-specific deliverables aligned with Clinilabs corporate strategy, metrics, style and branding parameters. • Ensures effective communication among internal stakeholders throughout the process so that the strategy drives the project, and the final document(s) achieves its goals. • Meets deadlines consistently by establishing priorities and target dates for document contributions, review, and approval by key stakeholders including executive leadership. • Works with administrative members of the business development team to maintain a current database of responses and text in Clinilabs proposal development software. • Other duties as assigned.

• Serve as Corelab Project Manager on studies, and/or site certification, device management, scoring reliability. • Provide leadership and guidance to Data Coordinators. • Create training & delegation of responsibilities documents for support staff. • Provide support and act as the point person to the Sponsor, CROs, vendors, clinical sites, and scorers for questions regarding core lab data management. • Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members. • Manage and track project timelines and quality issues. • Develop training and reference materials and/or presentations as needed. • Develop study-specific SOPs. • Coordinate and manage training, documentation, and communication with stakeholders. • Maintain and manage budget/finance tracker, and change order management. • Evaluate and analyze data submitted by various parties to ensure it meets the criteria set by the study protocol. • Monitor and update study database to ensure that all data is being processed in a timely manner. • Perform data entry and data QC. • Perform query generation and tracking and oversee query resolution. • Create a study-specific electronic regulatory binder and screening binders, where applicable. • File and store documents according to protocol. • Track study progress and issue periodic status reports as needed. • Manage and track study device database. • Assist in the creation and documentation of new or revised data management, IT and quality assurance procedures. • Communicate with all operational departments regarding project status/issues.

• Reconcile project budgets with project managers. • Keep accurate records of all changes and charge backs. • Recognize budget changes and point out when change orders need to be created. • Attend project meetings and identify when change orders need to be generated and ensure that process is started • Process approvals and payments for invoices submitted by sites/vendors; ensure payments are within contractual agreements • Identify out of balance accounting records and reconcile with site/vendor and the finance department • Communicate directly with the site and vendors to resolve invoice differences • Conduct Quality Control process reviews and remediate as needed • Maintain the clinical financial database • Ensure documentation is maintained to support an audit trail in the accounting system • Support the Clinical relationship with Finance • Interface with Accounting for the close/reconciliation process • Serve as the Clinical Finance representative for study teams • Provide data for clinical trial forecasting and budgeting process • Anticipate clinical trial budget revisions due to out-of-scope services, enrollment delays, etc. • Process financial termination/closure of study sites • Process monthly clinical dashboard • Provide actual cost budget analysis • Adhere to appropriate quality documents (e.g. SOPs, Training Guides), as applicable including EP and SOPs and processes. • Other duties as assigned