Abiodun Awe

• Project Profile: Data Management Plan, Data Review, 21 CFR Part 11, eCRF, EDC, CDISC (SDTM, ADAM, and CDASH), Good Clinical Practice (GCP)
• Developed and designed CRF completion guidelines for studies, per the study's protocol.

• Designed and created Case Report Forms (CRFs) per the clinical protocol, utilizing Clinical Data Management standards.

• Served as Clinical Data Manager on two individual Phase III randomized oncology studies.

• Created clinical data management plans (DMP) and related deliverables and maintained the DMP though the project lifecycle according to study design and requirements.

• Performed protocol level clinical data review and cleaning activities supporting the clinical trial and maintaining protocol data quality.

• Performed Data Validation and Data cleaning by Peer-Reviewing Made changes in the production and the QC
programming as per the client specifications.
• Proficient in handling Program files, Log files, Listing files and Data sets.
• Interacted with statisticians and discussed the various updates in the specification.
• Identified study setup, validation errors and provided resolutions tracked by the Queries and Decisions Log Write,
reviewed, and approved Data Management Plans and other key study documentation.
• Created, reviewed, and processed data clarification forms and update the database.
• Prepared validation reports and trial evaluations.
• Participated in the study start-up process by performing User Acceptance Testing of the database, validation procedure testing, and providing feedback to the clinical database programmers.
• Regularly attended meetings with monitoring, database programming, medical coding, and statistical
programming teams to ensure study progression.
• Served as the main point of contact with the site facing role in the clinical data review process.
• Supported in training of project staff including CDCs and CRAs on project specific or data management
processes.

• Maintained detailed records of services performed on clients.
• Developed plans for respite care when needed based on availability of family members or other caregivers.
• Assisted clients with daily living activities such as bathing, dressing, and grooming.
• Helped maintain the safety of the client's environment by removing hazards such as rugs or furniture that could cause falls.
• Followed care plan and directions to administer medications.
• Performed light housekeeping tasks related to the client's care such as laundry and changing linens.
• Prepared meals according to dietary requirements and assisted with feeding when necessary.
• Observed changes in behavior or physical condition that may require medical attention and reported them promptly to supervisor.
• Ensured compliance with all applicable laws, regulations and standards governing home health care services.
• Collected and recorded patients' blood pressure, pulse, and respirations (TPRs) to evaluate and note basic health status.
• Instructed family members on how to provide bedside care.
• Maintained accurate records of services provided, changes in client condition, medications administered and other pertinent information.
• Provided emotional support for clients who were experiencing depression or anxiety due to their illness or disability.
• Educated families about available resources for home health care services in the local community.
• Aided with mobility and independence for disabled individuals and continually monitored safety.
• Consulted with client care team to continually update care plans.
• Worked closely with clinical staff to support therapeutic and behavioral plans.
• Helped clients get in and out of beds and wheelchairs.
• Monitored vital signs, including blood pressure, temperature and pulse rate.
• Organized oral medications for clients following dosage and schedule requirements.
• Administered prescribed medications on a timely basis following care plan instructions.