The Senior Central Report Reviewer (SCRR) has the overall responsibility for execution ofCentral Report Review activities on an assigned study. The Senior Central Report Reviewerperforms report reviews and approves reports for Phase I-IV clinical research studies to assesscompliance with the protocol, ICHGCP, and/or all applicable local and federal regulatoryrequirements as well as ensure patient safety and data integrity using a variety of technologies.In addition, the SCRR ensures that any trip report fully reflects conducted monitoring activity,and report finalization timelines are compliant with SOP, regulatory guidelines and MonitoringPlan. Will use analytical skills, critical thinking, data and information analysis, research andcommunication to problem solve. Performs all tasks routinely and independently. Providesupport to other CRR / CTM including training and mentoring.

The Central Monitoring Lead (CML) has the overall responsibility for execution of Central Monitoring activities on a study. The CML is assigned with study-level data and Key Risk Indicators (KRI) review responsibilities based on Risk Based Monitoring (RBM) strategy employed. CML performs report reviews and approves reports for Phase I-IV clinical research studies to assess compliance with the protocol, ICH/GCP, and/or all applicable local and federal regulatory requirements as well as ensure patient safety and data integrity using a variety of technologies. In addition, the CML ensures monitoring activity conductedand report finalization timelines are compliant with SOP and Monitoring Plan. Will use analytical skills, critical thinking, data and information analysis, research and communication to problem solve. Performs all tasks routinely and independently. May provide support to other CML including training and mentoring

The Clinical Operations Manager serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). The position as defined by scope provides leadership, mentoring, and technical support to the Clinical Operations team to ensure quality of deliverables and achievement of financial goals. May provide administrative line management, which includes oversight of training, compliance, performance and career management, and development of direct reports.JOB RESPONSIBILITIES • Ensures quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. May include the development of the Clinical Management Plan (CMP)/Site Management Plan (SMP). • Ensures alignment of clinical activities to budget, including identification of out of scope activities.• May participates in business development proposals, defense meetings and proposal development.• As required, provides development and delivery of initial and ongoing training to the study team • Evaluate staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process.• Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct. • Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan. Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.• Develops and executes corrective action plans at site and study level, proportionate to the risks identified.

Working for MSD under Covance contract.• Ownership of country and site budgets.• Development, negotiation and execution of Clinical Trial Research Agreements (CTRA).• Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.• Oversight and tracking of clinical research-related payments.• Oversight of FCPA, Denied Parties Screening and maintenance of financial systems.• Financial forecasting and tracking of operational budget in conjunction with the client manager.• ResponsiЫe for execution and oversight of clinical trial country submissions and approvals for assigned protocols.• Development of local language materials including local language lnformed Consents and translations.• Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.• Deliver the expertise in country based regulations, laws and procedures• ResponsiЫe for managing country deliveraЫes, timelines and results for assigned protocols to meet country commitments.• Contributes to the development of local SOPs.• Мау oversee contract workers and local vendors as applicaЫe.• Works in close collaboration internally with Clinical country operations, Country Quality Manager, Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliveraЫes are oblained for submissions, budgets, CTRAs and milestones.• Collaborates closely with Regional Operations to align country timelines for assigned protoco\s. Provides support and oversight to local vendors as applicable.• ResponsiЫe for clinical and ancillary supplies management, importing and exporting requirements.• Enters and updates country information in clinical, regulatory, safety and finance systems.

The LTM is the primary point of contact at a country level for assigned studies.The LTM is responsible for coordinating and leading the local trial team. LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants, Site Managers and LTMs. 1.Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM. Implements any local criteria for site selection. Recommends suitable sites for selection to participate in trial.2. Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.3. Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.4. Lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.5.Conducts local trial team meetings and provides or facilitates SM training when needed 6.Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed7.Acts as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.8. Participate in EC/MoH submissions

1.Study Planning activities:Site identificationAssess potential investigators and decide on the suitability of the siteReview the site commitment in detail with the investigator2.Study start-up activities:Site start-up Develop/adapt recruitment and retention strategy for the siteEnsure that the current versions of the trial documents that and all required trial-related materials and supplies are provided to the investigational siteSet up the IF and TCFWhen local Ethics Committees are used, ensure that the IEC/IRB is provided with current and complete copies of all documents that the IEC/IRB requests and obtain a copy of the valid written IEC/IRB approval and all related required documents.Obtain site related trial documents and review them for completeness and accuracyPlan and conduct investigator and site-staff trainingConduct site initiation visits3.Study execution activities:Site management At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored and returned, accurately inventoried and documented. Inform the investigational staff of the distribution processFollow up with the trial site regarding case report forms and data correction formsConduct monitoring visits according to the checklist of activities listed on the Monitoring Visit ReportEnsure that all AEs/SAEs/PQCs are reported within reporting timelines and documented as appropriate. Arrange for the appropriate destruction of clinical drug suppliesIn studies where IVRS is used: Ensure that the IVRS at the site has been activated and tested and that unblinding capabilities are operational for those authorized to unblind subjectsEnsure TCF is maintained as required and maintain IFEnsure subject commitment per site is met4.Study close out activities:Site close-outConduct site closure visits5. ICF Development6. Co-monitoring visits (quality visits)7. LTM (Lead CRA/LTM) back up

Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Performs responsibilities with minimal support from management. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.Report to Pharmanet/i3 project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.Maintain project tracking system of subject and site information.Participate in company-required training programs.Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance).Perform other duties as assigned.

Participation in II-IV phases clinical trials.Working as SU CRA•Perform feasibility management and Site Qualification Visits.•Perform pharmacy monitoring procedures. Perform unblinded routine site visits, including pre-study, initiation, interim, closeout visits. To monitor if the IP storage and accountability are compliant with the protocol. •Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.•Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.•Report to Pharmanet/i3 Research project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.•Maintain eClinical or alternative project tracking system of subject and site information.•Participate in company-required training programs. •Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance).•Perform other duties as assigned.

•Participated in co-monitoring visits including interim and closeout visits. Co-visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance.•Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.•Worked as a CTL-support. Organized CRAs work in accordance with CTL terms. Was responsible for setting out deadlines and time frames for CRAs and ensure that they are carried out. Organized teleconferences to ensure that study was conducted properly, complied with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements. Reported directly to CTL and sometimes to sponsor any issues which could impact on clinical trial proper conduction.•Performed Submissions to Regulatory body.•Performed Submissions to Ethic committees.•Performed Collection of regulatory packages.•Worked with institution and investigator contracts.•Performed investigator and hospital payments.•Performed Query resolution.•Performed Management of SAEs.•Worked with paper and eCRFs.•Performed accurate completion of study files.•Kept sure that all electronic databases were filled in accurate way.•Was responsible for mentor functions.•Participated in company and sponsor-required training programs.

•Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.•Performed Submissions to Regulatory body.•Performed Submissions to Ethic committees.•Performed Collection of regulatory packages.•Worked with institution and investigator contracts.•Performed investigator and hospital payments.•Performed Query resolution.•Performed Management of SAEs.•Worked with paper and eCRFs.•Performed accurate completion of study files.•Kept sure that all electronic databases were filled in accurate way.•Participated in company and sponsor-required training programs.