Drive Portfolio Execution and Delivery• Oversees daily business activities and communications between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior Management and investigational sites to drive project performance• Collect and extract project, business, and financial data from warehouses for reporting, using querying techniques• Facilitates the development of clinical strategy and trial milestones and communicates this both internally and to external stakeholders• Drives key business communication on behalf of the business unit• Provides study-specific training to internal team members and site personnel• Oversees the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction for structural heart• Work with team and personnel at each clinical site to ensure that trial execution and trial milestones are met• Monitors global study status for continued compliance regarding institutional, state, and federal regulatory policies, procedures, directives and mandates• Identify and maintain project proposals in support of the 5-year site strategy.• Establish project execution prioritization tools and processes that impact customer satisfaction levels, allocation of time, resources, expenditures, and funds across multiple departments within the site.• Provide feedback to functional department heads during AOP/strategic planning process.

• Plans, directs, creates and communicates clinical study time-lines.• Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule.• Ensures consistency of clinical study and processes across clinical trials.• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets.• Ensures study is conducted within clinical trial protocols.• Monitors progress and follows up with team members and line managers when issues develop.

Serves as primary contact between Novella and investigator with regards to study Eligibility Committee; coordinates all correspondence; ensures timely transmission of Eligibility Committee clinical data with the study site and technical reporting, as requested.Performs site staff initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on eCRF completion and the use of the EDC systemServes as an in-house CRA responsible for site management, data review, and/or query resolution on assigned projects. Collaborates with (field) CRAs on assigned sites. Serves as Novella’s in-house expert on assigned sites (for example, patient enrollment, protocol compliance, study site staff issues, IRB and regulatory document status, data status, and other site metrics)Liaison with sponsor, monitors, and investigative sites to resolve subject eligibility and enrollment issues identified through ongoing weekly enrollment review in a timely mannerIn collaboration with the assigned (field) CRA, performs routine site management activities, including site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study protocol, applicable regulations and guidelines, and sponsor requirementsReviews the quality and integrity of patient data at assigned sites through the in-house (remote) review of electronic CRF data. Ensures timely transmission of clinical data from assigned study sites, and works with sites to resolve data queries.Performs risk–based quality trial management to identify, assess, control, communicate and review study risk. This data surveillance is performed at specified intervals and throughout the duration of the trial per the study plan.

Reviews regulatory documents for proper content in accordance with FDA, ICH/GCP’s, PPD and client company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the Client. Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools. Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner. Develops and maintains assigned data points within the clinical database according to the established conventions and streamlining tool for the project within specified timeframes.Oversees the execution and dissemination of study related information, including project tracking updates to Clients, clinical study teams and other PPD departments. Provides technical support to Project Manager and other team personnel as needed to comply with contract deliverables. Liaises with clinical project team and investigative sites to coordinate non-clinical/clinical issues on multiple studies. Assists with the identification of potential investigators and development/distribution of initial protocol packets. Responsible for facilitating the administration of investigator grant payments.Responsible for participation in internal/client meetings and creating agendas and minutes.Responsibility to coordinate team conference calls and completion/distribution of meetingAssists in the assessment and implementation of project specific training activities for new clinical staff.

Works with the Clinical Monitoring Management Team in achieving higher levels of compliance with processes, better quality and drive initiative by working with the various departments. Responsible for setting up and analyzing metric reports of departmental performance. Ensures the implementation of new processes designed to improve performance within the department. Responsible for establishing effective communication channels across various Clinical Operation functions within the company in order to drive operational excellence. Provides quality support and guidance on company processes to Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) working on research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures.

Project Duties:1) Maintain/revise workbook of reports from multiple sources including EDC and IVRS, to aid Clinical Trial Mangers in study maintenance and accountability of Clinical Research Associates2) Arrange client meetings:3) Manage internal file audits4) Review, confirm and edit the Clinical Master Plan5) Maintain/revise Frequently Asked Questions document using project protocol6) Answer and correct queries in EDC system for weekly client calls7) Manage and record feasibility reports8) Send daily packages of trip reports to client within designated timeline9) Save and upload all finalized trip reports in InfoLink10) Upload SEV confirmation emails in InfoLink11) Create monitoring visit metric worksheet using weekly 12) JReview monitoring visit reports for client audit13) Compile mail merge for sites combining feasibility questionnaire and SEV trip reportsDepartment Duties1) Develop budget for department meeting2) Research and locate off-site meeting space and hotel arrangements, serve as point of contact for hotel staff 3) Serve as contact person for all out-of-state attendees 4) Collect, organize and assist in running presentations 5) Coordinate and participate in team building exercises

•Developed enthusiastically satisfied customers all of the time.•Provided quality beverages consistently for all customers.•Maintained quality store operations•Contributed to store profitability¬

•Assembled laboratory experiments. Cleaned laboratory after classes.•Created media presentation for classes and tutoring sessions.•Assisted students during lab sessions. Assist professor with research for publications and instruction.¬

•Tutored students in specific course material and integrate study and learning strategies to promote independent learning.•Maintained a consistent weekly schedule of work hours in the Student Services Center for appointments and walk-ins.•Developed handouts and other instructional materials, worked on projects assigned by the Director, and helped to keep the center running smoothly and efficiently.¬

-Maintained and cleaned the Discovery Room for small children to engage in science through hands-on activities.-Designed animal masks for children costumes.-Collected birds at Prairie Ridge for annual bird banding.-Obtained animal handling training through Living Collections.Performed weekly maintenance on fish collections in research lab.-Assisted in programs and events at Prairie Ridge and Windows of the World -Attended staff meetings¬