Mariam Jay Email & Phone Number

Atlanta, Georgia, United States

Trial Manager Mar 2020 – Till Date• Act as the primary point of contact supporting the planning and execution of sponsored clinical trials (phases I-IV). • Manage study start-up and developed clinical study plans, Investigator site templates. • Prepares and presents materials for Investigator meetings and CRA training. • Reviews and approves investigator site payments. • Reviews and approves CRA expenses… Show more Trial Manager Mar 2020 – Till Date• Act as the primary point of contact supporting the planning and execution of sponsored clinical trials (phases I-IV). • Manage study start-up and developed clinical study plans, Investigator site templates. • Prepares and presents materials for Investigator meetings and CRA training. • Reviews and approves investigator site payments. • Reviews and approves CRA expenses and timesheets. • Provide leadership and site relationship management to Clinical Trial Partner sites to support the optimization of key processes and ensure critical trial milestones/timelines are met. • Support the Feasibility process to ensure site selection is completed per the expected timeline. • Review trip reports and manage CRAs to ensure quality and compliance per annotated trip report. • Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs• Provide training as needed for monitors and any other activities that support site readiness to recruit, and inspection readiness. • Manage and lead cross-functional study teams, including vendors. • Support the project manager/director with establishing study milestones and accurate tracking. • Confirm that the eTMF is correctly set up and maintained appropriately throughout the trial. • Participates in periodic reviews of the scope of work, vendor performance, and issue resolution. • Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials.• Provide direction and leadership in CRO and vendor selection and management.• Knowledge of regulatory start up process and planning in support of study start -p• Managing and maintaining high performing clinical teams. Show less

Atlanta, Georgia, United States

• Was responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget, e.g., implementation of protocol and amendments; protocol deviation prevention, tracking, and reporting; IP management.• Interfaced with client and program/project staff; ensured the provision of meeting agendas and summary documentation and /or detailed information as required for internal and client meetings.• Lead clinical team meetings and prepare sections… Show more • Was responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget, e.g., implementation of protocol and amendments; protocol deviation prevention, tracking, and reporting; IP management.• Interfaced with client and program/project staff; ensured the provision of meeting agendas and summary documentation and /or detailed information as required for internal and client meetings.• Lead clinical team meetings and prepare sections for monthly, quarterly, and annual reports; and, present at internal meetings.• Ensure successful site startup, maintenance, and close-out.• Successfully deliver operational activities, such as study start-up, site management, clinical monitoring, and data management activities.• Oversight of the management of sites to ensure compliance with the protocol, ICH-GCP, other relevant guidelines, and applicable regulations, as well as SOPs.• Deliver the project/program according to the quality management plan. Guide CRAs and advise on critical specific study issues.• Drive high performance and efficiency of the clinical team through CRA project objectives and the conduct of monitoring visits. Provide performance feedback to management on clinical team members.• Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer.• Provide ongoing training and support to the clinical team. Conduct frequent teammeetings and ensure regular communication.• Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target andcontingency plans are in place and deployed at trigger points.• Deliver the project/program according to the quality management plan. Guide CRAs and advise on critical specific study issues. Show less

Atlanta, Georgia, United States

- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.- Collaborated with clinical study site and sponsor to troubleshoot and… Show more - Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.- Followed drug storage procedures to comply with protocols and SOP requirements.- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.- Created and maintained database and records filing system to document data on specimen collection, processing and storage.- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.- Gathered and organized clinical trial documentation to meet rigorous standards for site approval. Show less

Atlanta, Georgia, United States

- Served as the primary contact to ensure appropriate communications, trial management, and meeting of timelines.- Coordinated the operational aspects of new and ongoing clinical trial at the site.- Worked under the supervision of the Principle Investigators, while exercising excellent clinical judgment in patient monitoring and care.- Maintained daily contact with the Principle Investigators for recruitment activities, study start up, and general daily communication.-… Show more - Served as the primary contact to ensure appropriate communications, trial management, and meeting of timelines.- Coordinated the operational aspects of new and ongoing clinical trial at the site.- Worked under the supervision of the Principle Investigators, while exercising excellent clinical judgment in patient monitoring and care.- Maintained daily contact with the Principle Investigators for recruitment activities, study start up, and general daily communication.- Responsible for the execution of the protocol and ensuring that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained on the protocol.- Assisted with patient recruitment and pre-screening.- Maintained and submitted IRB communications and regulatory documents.- Provided timely communication with internal teams, investigators, review boards, and study subjects.- Prepared other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs. Show less