- Adhere to scope and routinely review Clinical Trial Management System (CTMS), CaseReport Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment,Data Visualization dashboards (where available) to oversee site and study team conduct, toensure timely entry of all operational aspects (required visits/calls, duration, and frequency)according to plan, and to oversee site and study team conduct and identify any risks to deliveryor quality.- Ensure quality of the clinical monitoring and site management deliverables within a projectand maintain proper visibility of its progress by the use of approved systems and/or trackingtools. May include the development of the Clinical Management Plan/Site ManagementPlan.- Understand the monitoring strategy required for the study and where required participate inthe development of the study risk assessment plan. Accountable for the clinical teamsunderstanding, ongoing compliance and delivery according to the stated monitoring strategy,CMP/SMP, and risk plans.- Review the content and quality of site monitoring documentation (site monitoring calls, sitevisit reports, site letters, and pertinent correspondence), to ensure they represent sitemanagement activities and conduct. Ensure these deliverables are provided according tocompany and/or sponsor specifications, including delivery deadlines.- Interact with the client and other functional departments related to clinical monitoring and sitemanagement activities and deliverables.- Maintain compliance in assigned region or project for performance, deliverables, andassociated Key Performance Indicators.- Ensure alignment of clinical activities to budget, including identification of out of scopeactivities.- Collaborate with other functions to ensure site compliance and delivery according to protocol,ICH/GCP and/or GPP, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for Clinical Scope.

• Accountable for the operational delivery (site activation, subject recruitment, site management, dataintegrity, project quality) of clinical studies assigned by the Real-World Evidence department.• Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with theagreed Start Up strategy and COP.• Develop & maintain clinical project plans, including but not limited to i.e. Regulatory Start UpManagement Plan, Clinical Operations Plan, Recruitment plan etc.• Real World Evidence Group resource request review and alignment from project award and during entireduration of the project.• Ensure overall project efficiency and adherence to project timelines and financial goals.• Responsible for the functional financial delivery of the project• Monitor progress against contract and prepare/present project information proactively to all stakeholdersinternally and externally as required.• Support the delivery of the project according to the quality management plan. Guide SiteManagers/Clinical Research Associates and advise on critical specific study issues.• Collaborate with other functional groups within the company where necessary to support milestoneachievement and to manage study issues and obstacles.• Identify risks (positive and negative) which could impact on the operational delivery of the project anddetermine contingencies. Partner with functional leaders in problem solving and resolution efforts.• Ensure accurate completion and maintenance of internal systems (with emphasis on Clinical TrialManagement System), databases, tracking tools, timelines and project plans with project specificinformation.

- Perform site selection, start-up/regulatory, initiation, monitoring, and close out visits.- Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU), and Epidemiology.- Administer protocol and related study training to assigned sites and establish 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 and when applicable escalate quality issues.- Execute assigned work efficiently and adhere to project timelines and financial goals.- Manage 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.- Create and maintain 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.- Provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation, and other monitoring activities.

- Serves as the primary contact and company representative for sites on assigned studies.- Manages assigned sites via outbound telephone calls, web-based tools and other communications tools to ensure compliance with the protocol requirements, study procedures and relevant guidelines.- Creates contact reports for each telephone session (outbound or inbound) with sites.- Ensures all assigned sites are trained on the study protocol, informed consent process, data collection requirements/data collection tools (e.g., Electronic Data Collection (EDC) systems, Interactive Voice/Web Response (IVR/IWR) systems, etc.), Serious Adverse Event (SAE) reporting requirements and patient-reported outcomes instruments, as applicable.- Monitors site performance metrics and, with guidance, implements action plans for sites not meeting expectations.- Supports patient enrollment at each assigned site via engagement of sites in study-wide patient recruitment programs or through development of site-specific enrolment plans.- Monitors all types of Phase II-IV clinical trials; participates in all types of remote site visits.- Assures timely completion and submission of Electronic Case Reports Forms (eCRFs) in accordance with study-specific clinical and data management plans.- Maintains awareness of key study performance indicators for assigned sites, e.g. Telephone Communications Reports, patient enrolment, and SAEs/Endpoints.- Updates study and patient status information. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from contact to contact.

-Responsible for monitoring all types of clinical trials l; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures -Primary responsibility is for site management and performance, including documentation. Site management activities include all in-house and on-site monitoring for all visit types. -Therapeutic focus: General Medicine

- Serves as the primary contact and company representative for sites on assigned studies.- Manages assigned sites via outbound telephone calls, web-based tools and other communications tools to ensure compliance with the protocol requirements, study procedures and relevant guidelines.- Creates contact reports for each telephone session (outbound or inbound) with sites.- Ensures all assigned sites are trained on the study protocol, informed consent process, data collection requirements/data collection tools (e.g., Electronic Data Collection (EDC) systems, Interactive Voice/Web Response (IVR/IWR) systems, etc.), Serious Adverse Event (SAE) reporting requirements and patient-reported outcomes instruments, as applicable.- Monitors site performance metrics and, with guidance, implements action plans for sites not meeting expectations.- Supports patient enrollment at each assigned site via engagement of sites in study-wide patient recruitment programs or through development of site-specific enrolment plans.- Monitors all types of Phase II-IV clinical trials; participates in all types of remote site visits.- Assures timely completion and submission of Electronic Case Reports Forms (eCRFs) in accordance with study-specific clinical and data management plans.- Maintains awareness of key study performance indicators for assigned sites, e.g. Telephone Communications Reports, patient enrolment, and SAEs/Endpoints.- Updates study and patient status information. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from contact to contact.

Perform investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities

Perform investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities

 Exposed to working with a diverse range of people. Experienced working in group as well as individual situations. Coordinated various programs and events for residents to attend. Assisted residents as a campus liaison. Constructed many different various forms of paperwork.