Kate Akers Email & Phone Number

New York, NY, US

Medidata Solutions Consultants (pre-sales engineers) partner with Client Executives and Solution Sales Specialists to drive complex sales cycles across multiple stakeholders within large global clients. Solution Consultants are the technical counterparts in driving account/opportunity strategies, white space analyses, discovery conversations.

Scottsdale, Arizona, US

 Developed the Trial Start-Up and Activation model for TD2 with multiple Clinical Trial Start-Up processes and working documents to implement a proven, data-driven activation method reducing the Sponsor’s wait time for First Patient, and the site’s burden and touch-time on multiple items while achieving site activation more efficiently – ultimately.

Raleigh, North Carolina, US

• Prioritizes and effectively manages the oversight of the Start-Up strategy and execution with cross-functional team members for assigned studies including, but not limited to, supporting site identification/site.
• Creates, maintains and collaborates on applicable project documents, plans, templates and tools. Analyzes and actions metrics and reports of performance against key performance indicators.
• Monitors team and individual performance, providing feedback to individual and functional manager (FM) as appropriate.
• Ensures quality standards and applicable regulatory requirements are met, in accordance with the protocol, applicable guidelines and local regulations for IP release and site activations.
• Communicates effectively with sponsor, project manager, functional team leads and other project team members regarding study Start-Up strategy and risk mitigation planning. Selects appropriate communication platforms.
• Maintains detailed knowledge of study Start-Up resource requirements, burn rates and plans accordingly, ensuring timelines, quality standards and budget expectations are met, reconciling with project manager as.

Dublin, IE

• Accountable for development, implementation, and execution of the Study Start-Up Strategy from PSV to SIV in all countries.
• Ensure each project is being conducted in accordance with the Study Start-Up Strategy plan in an effective manner, meeting and beating sponsor timelines and expectations.
• Prepare and coordinate Study Start-Up team, project, and portfolio status, metrics, and data.
• Submit amendment requests from coordinating leads.
• Development and finalization of Master and Country Specific SIS/ICF.
• Review submission packages and provide support for submission amendments.

Princeton, New Jersey, US

• In conjunction with Study Team and Sponsors, determine what study program services need to be contracted with 3rd party vendors.
• Identify qualified vendors to provide study services utilizing the qualified/preferred supplier list, where appropriate.
• In conjunction with the Study Team and Sponsors establish criteria for RPP/RFI for 3rd party services.
• Manage negotiations with 3rd Party providers.
• Establish working relationship with selected vendor(s).
• Manage Contract, Task Order and Budget reviews to ensure appropriate scope, pricing and SLA’s are included in vendor contracts and task orders.

Princeton, New Jersey, US

• Work directly with Sponsor in order to ensure accuracy on regulatory reporting and submission to Trial Master File
• Review and approve IRB-approved documents from investigators as well as all regulatory documents
• Drafted and finalized Investigator Package Plan for Phase 1 portfolio
• Liaise with operational project team regarding project issues
• Review and approve core English/Country patient informed consents for compliance to international and country requirements and protocol as applicable
• Review and approve investigative site specific patient informed consents for required elements

Princeton, New Jersey, US

• Primary contact with investigative sites during site start-up activities with responsibility for collection of the required investigator and regulatory documents for a study and ensuring that the documents meet the.
• Maintenance of allocated site’s information in the Trial Tracker™ Site Information Module study database as well as maintenance of regulatory documents throughout the duration of the clinical trial
• Working with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans.
• Final review and approval of regulatory documentation for sites managed by another GSS professional (final independent review)

Princeton, New Jersey, US

• Provide clerical support to project team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy, assemble study documents, and.
• Set up and maintain clinical investigator files and documentation
• Prepare investigator budget payments and tracking systems; generate tracking reports as assigned
• Data entry and maintenance of selected study tracking databases

Nashville, TN, US