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, presentations, demonstration and sale of all Medidata applications and services.

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 creating shorter timelines and repeat business  Proven efficient Trial Start-Up and Activation model by achieving First Site Activated within an average timeline of three weeks to three months post Site Selection on six trials within one year  Created new Standard Operating Procedures to define and outline Trial Start-Up and Activation model, as well as create all templates and working documents  Spearheaded working group initiatives for CTMS and eTMF training with a knowledge-based approach to incorporate existing trials for streamlined processes  Initiated a Site Engagement Network with a portfolio of select sites, managing monthly round table discussions and being the main point of escalation resulting in quicker timelines with better working relationships, solution-based conversations, and quality data output during the trial  Ensure accelerated Start-Up strategies are leveraged across TD2’s site network Responsible for ensuring activities are being conducted in collaboration with Site Engagement and the Clinical Operations Team in accordance with the Trial Start-Up Plan in an effective manner to meet (or surpass) Sponsor timelines and expectations Serve as CRO primary point of contact with research sites for Start-Up through Activation which includes managing and negotiating the contract and budget, ICF revisions, IRB approvals, regulatory document review, and obtaining all necessary licenses and processes are in place for patient safety

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 recruitment/site selection, central and local submissions, site contracts, essential document preparation, Investigational Product (IP) release, site initiation visits (SIVs), and overall site activation readiness, to ensure deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations. • 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 to convey information effectively and efficiently. Leads team meetings; presents at intra-/inter-departmental and external meetings. • 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 appropriate. Forecasts according to contractually agreed units/hours, tailoring to manage fluctuation of activities throughout Start-Up. • Conducts global analysis of Start-Up risks, acting and documenting in the appropriate system, escalating as appropriate through functional management and project manager.

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. • Track and report on status of follow up and response for queries raised by submission authorities. • Oversee day to day communications and delivery of all aspects of site Start-Up. • Ensure each project is in compliance with CRO/Sponsor SOPs, appropriate regulations, and operating at the highest of quality standards. • Manage and present at Sponsor initiatives such as kick-off meetings, bid defenses, weekly project update and status calls, and other daily communications. • Utilize proficient project management skills to optimize performance within Study Team and Sponsor to ultimately ensure successful study Start-Up outcomes. • Manage billable time for Study Start-Up team and report units spent per study budget projections to date.• Ensure accurate reporting of all activities included in the study budget and tracking of all out of scope activities with Sponsor approval to help facilitate any change orders.

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. • Maintain and report on status of vendor progress on tasks performed including management of Change Orders. • Obtain appropriate Project Management and Sponsor approvals for scope and budget documents. • Work closely with Vendor Relationship Management Group to ensure all vendor related documentation is approved and processed on-time. • Establish and maintain a good working relationship with the 3rd party vendors. • Serve as liaison between the Study teams, Sponsor and 3rd party vendor(s); ensuring that all issues are escalated appropriately and corrected prior to becoming project impacting. • Review and sign-off on vendor invoices to ensure that billing is appropriate based on the terms of the contract.

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• Liaise with Sponsor and Covance regulatory regarding document submission requirements • Assess impact of changes in study personnel and document amendments on regulatory documents and process/review/approve new documents according to GCP/ICH guidelines• Act as point person for global studies as assigned: maintain open communication with global colleagues, provide study Investigator information, collect data from appropriate regions and generate the formal report• Directly manage day to day conduct with clients for stand alone activities and other activities as appropriate

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 specifications required by applicable regulations• 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 for the successful implementation and conduct of global clinical trials• 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 arrange meetings, etc.)• 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