Jomia Michael

• Performing a wide range of Data Acquisition activities ensuring that the non CRF data is collected as per data collection standards.

• Leading the collection of non-CRF data during study set-up, conduct and close out activities across multiple studies, contributing to fit for quality.

• Responsible for data acquisition, specification, loading and delivery of non CRF data across different vendors.

• Providing input during protocol review to ensure clarity of data collection requirement.

• Identification of non-CRF data collection requirement from protocol. Creation and maintenance Data Handling Strategy (DHS) document after consulting with Client stake holders.

• Creation and finalization of File Format Specifications document in alignment with GDSR standards for non- CRF data collection.

• Collaborate with client to agree with vendor expectations for non CRF data collection and data transfer.

• Responsible for obtaining relevant signatures on finalized FFS, uploading finalized FFS PDF document in eTMF, uploading DHS and FFS in sponsor specific data storage repositories

• Raise tickets within Client systems for approval of non-CRF data collection requirements that are not covered in global standards via Virtual Desktop.

• Manage CDM non CRF deliverables, identify risks and coordinate cross functional tasks with adequate understanding of upstream and downstream processes, as applicable.

• Perform eTMF review to check completeness and compliance of FFS upload.

• Keep higher management fully informed about the study updates and challenges.

• Serves as backup to other Data acquisition specialist.

• Ensure to deliver high quality work and follow effective DAS processes within the function

• Ensures compliance to all relevant Client and TCS SOPs and documentation requirement of staff training / assessment

• Identify patient anomalies to ensure medical congruency/plausibility of a subject data per protocol

. • With minimal guidance, provide project management expertise working with clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.

• Maintain strong customer relationships. • With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions

• Ensure timely follow-up and resolution of compliance issues. • Serve as Subject Matter Expert (SME)

. • Serve as POC, in SSU phase - Update DER, DMP and SRD to ensure proper Spotfire build

• Serve as POC in SSU and Conduct- Effective project management through Stakeholder communication, Operational management, follow appropriate escalation pathways, timely resolution of issues and ongoing assessment of risk and proactive risk mitigation

• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables

. • Provide therapeutic area/indication training for the project clinical team.

• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

• Serve as a Subject level Data reviewer (SLDR) and identify any anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy

• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial

• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages

• Review all reported Adverse Events (AEs) , Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient information (e.g., laboratory results, AEs, etc.)

• Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending treatment or ending participation in the clinical trial

• Review all laboratory results to ensure completeness of information and adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient

• Review any other information as necessary to determine overall readiness of the patient information for next level review • Interaction with other Medical review staff to verify information and/or triage new data issues or prior identified action items

• Serve as POC/ Back-up POC • Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

• May act as a Clinical Data Scientist for performing data analytics by reviewing the visualizations and identify potential issues of concern

• Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

• Schedules study subject appointments and serves as the patient liaison to the PI and other participating physicians. • Reviews and comprehends each assigned protocol including study proceedings and timelines. • Working closely with the PI, CRC participates in an integral way in the informed consent process by communicating clearly with potential study subjects about protocol. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol in order to be able to answer all questions pertaining to the study posed during the informed consent process. • Coordinates approval of new study agreements and contracts. • Coordinates and attends sponsor Site Selection visits, Routine monitoring visits, and study close out visits. • Completes case report forms. Extracts data from patient file (Source documents) in a timely manner. • Responds to data clarification requests in a timely manner. • May attend Investigator meetings requiring travel and report pertinent information back to research team members. • Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement • Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, like study protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training. • Maintains subject screening logs and protocol deviation logs. • Maintains a excel sheet, tracking updates to database of all subjects enrolled on clinical trials. • Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits. • Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations. • Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis. • Ensures that all materials for each clinical trial protocol are available for subject enrollment. • Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure protocols are followed and that there is timely documentation and submission of study data.

• Performs specimen processing and shipment of biological specimen duties.

• Assists with development of study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.

• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.

• Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable IRB/IEC and applicable regulatory requirement.

• Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.

• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research