• Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for, multiple service, multiple country and/or multi regional studies. Understand project strategy and operationalize the agreed upon approach.• Develop integrated study management plans with the core project team.• Accountable for the strategic planning and execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.• Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.• Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.• Responsible for delivery and management of medium to large sized, multiple and full service, multi regional studies.• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.;• Serve as primary project contact with customer • Build the cross-functional project team and lead their efforts, responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;• Ensure the financial success of the project.• Identify changes in scope and manage change control process, as necessary.• Mentor less experienced project team members

• Participate in bid defense presentations in partnership with Business Development. • Develop integrated study management plans with the core project team.• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.• Serve as primary project contact with customer ensuring that proper communication is maintained. • Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.• Ensure the financial success of the project.• Forecast and identify opportunities to accelerate activities to bring revenue forward.• Collaborate cross functionally to support milestone achievement. Proactively manage study issues and risks while implementing contingency plans as required for continuous improvement. • Identify changes in scope and manage change control process as necessary.• Identify lessons learned and implement best practices.• Primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.• Oversee site management tasks while acting as a Clinical Operation Lead in conjunction with CPM role. • Assist with partnership level initiatives, ensuring close relationships with client at a partnership level.

• Manage the execution of the assigned regionally-based clinical studies per Contract, from initiation through to closeout. • Ensure that all clinical study management and project deliverables are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices.• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.• Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.• Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.• Collect information on team performance against contract, customer expectations, and project baselines.• Lead problem solving and resolution efforts to include management of risk, contingencies and issues.• Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.• Provide input for the development of proposals for new work and manage project budgets.• Provide input to line managers of their project team members' performance relative to project tasks.• Prepare and present project information at internal and external meetings.• Participate in proposal development and in the bid-defense process with guidance and supervision.• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.

• Oversaw the work of 6 assigned site management staff and 1 CRA, providing advice and guidance to help achieve quality deliverables on site.• Assisted with the development of Site Recruitment, Clinical Operations Plans, Protocol Deviation Management Plan, SPS Operations and SPS Risk Management Plans.• Ensured that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations, per contract.• Collaborated with other functional groups within the company such as project management, data management, safety, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.• Managed and followed study activities through ongoing tracking and review of study progress. Report progress to appropriate SPS management and project management leaders.• Ensured accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.• Provided input and updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables.• Acted as the first line of escalation for site management questions and issues for their assigned projects. • Reviewed site visit reports and telephone contact reports. • Managed monthly finances and hours per study scope of work.• Managed Sponsor requests in a timely and professional manner, including regular reporting and Ad-Hoc requests. Received positive rating and response from Sponsor throughout study. • Performed site wide Protocol Amendment Training. • Met enrollment goal of 1505 patients enrolled.• Successfully completed Interim Analysis.• Involved in Quintiles QA and Sponsor Audits and CAPA creation and execution. • CTMS Champion and UAT Tester.

• Complete appropriate therapeutic, protocol and clinical research training per the established Early Talent Training roadmap to perform job duties.• Perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.• Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

• Effectively performed remote site selection, start-up/regulatory, site initiation visits, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs and work instructions. • Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation. • Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.• Managed the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. • Documented and tracked all communication (email, voice, fax, call reports) with study site personnel and client interactions, in accordance with study plans.• Coordinated site recruitment and enrollment efforts. • Followed established guidelines in the collection and tracking of clinical data and resolution of data queries in accordance with study plans and client preferences. Evaluate and assure quality of data collected; ensure that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protection.• Assisted the clinical team in the filing and archiving of clinical documentation according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.• Monitored site and subject progress, including documentation and reporting of adverse events; identify and escalate need for corrective actions to line manager as appropriate.

• Client focused approach while continuing to evaluate internal risks. • Increase patient safety by ensuring clinical staff is fully trained on study procedures prior to monitoring study data. • Analyze the operational study status (planned versus current) and reporting activities. • Perform set-up of project schedule, manage updates of schedule identifying areas for decreasing project timelines.• Initiate, set-up, and manage client and investigator site portal and management systems.• Design study newsletters to be sent out to sites.• Manage project resourcing. Complete resourcing requests. Compare resourced vs. actual, increasing project profitability. • Successfully performed migration of entire study from previous manual tracking of Project Specific training into Learning Management System, assessing staff needs for trainings.Arrange project related training for project team members and new team members and maintain project specific trainings overview and records, including study specific system training and access for PI, site staff, new site staff, study team and new study team members.• Develop project plan including all sub plans and evaluating need for revisions on regular basis during study maintenance. • Simplified and improved productivity of the payment process for Investigator site and IRB payments and ensured that sites were being paid appropriately and on time for patient visits. • Reduced time spent for payment process. • Proven ability to communicate with the client as well as across cultures.• Formulate study scenario planning and recruitment calculator updating enrollment projections and current enrollment data as needed. • Develop routine Client Report • Attends Investigator meetings and Kick-off meetings. Attends project and Sponsor meetings as required. Create meeting agendas and document action items.• Mentor new hires offering day-to-day help and assistance with queries.

•Successfully performed patient focused coordination of multiple clinical trials simultaneously in compliance to FDA, ICH, GCP, Protocols, Informed Consent, Study Visit Schedules and other policies and procedures as applicable. •Successfully screened and enrolled subjects in several difficult and high enrolling protocols while also focusing on patient safety.•Coordinated and performed responsibilities as related to the research participants including: determined subject population availability, developed source documents in accordance to study protocol, recruited and screened subjects, scheduled visits, obtained informed consent, completed of subject assessments, completed source data, recognized, tracked and reported adverse events and protocol deviations, completed drug accountability. •Performed technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.• Accomplished cleanup of longitudinal study, with numerous quality issues while ensuring patient safety and in continued trial visits. Organized binders and source documents for roughly 100 subjects following up of missing data needed.•Performed quality control (QC) of patient study charts at sister site identifying quality issues. Formulated a quality assurance plan for the site and guided fellow coordinators on appropriate documentation of source data. • Scheduled and participated in monitoring activities.• Entered visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF).• Performed study start-up duties including, chart and database review, phone screening participants, Qualification Visit and Site Initiation Visit. •Attended Investigator Meetings as well as other sponsor required meetings.

• Performed Validation and QC (Quality Control) of the User Acceptance Testing (UAT) process. • Developed and implemented plan for internal audit of employee training records.• Facilitated testing of system implementations. • Designed and validated network-based, protocol specific databases.• Generated and maintained data management documentation, including database definitions and validation procedures. • Ensured accuracy and completeness of clinical coding.• Designed CRFs (Case Report Forms) based on approved protocols for clinical trials.