Swad Timbo

Same as previous role. Additional responsibilities as a Senior include:

• Contribution to process improvement initiatives to enhance operational efficiency.
• Participate in Health Authority and IEC/IRB submission processes as required.
• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.

Responsibilities same as previous role (as external staff). Additional responsibilities since becoming headcount:

• Local expert in assigned protocols and demonstrates therapeutic area knowledge.
• Mentor and provide buddy support for new hires/junior staff.
• Participate to process improvement and training. MaSCoT Champion since 2023.

• Perform a variety of visits at site including site selection, site initiation and interim monitoring visits.

• Ensure compliance with GCP + protocol at site when reviewing subject + study documentation. In addition, reviewing study personnel qualifications, documentation, and training and ISF filing.

• Verify and review source data against EDC during MV, raise data queries and work with site to complete data
resolution in a timely manner.

• Review and verify IP accountability, dispensation and compliance at site.

• Work collaboratively with local and central team members to provide study and site activity updates.

• Support site with any issues identified, ensuring timely resolution in addition to adequate
documentation.

• Update relevant study tracking systems.

• Experienced in Paediatric/Teenage and Young Adults Haematology (Non-Hodgkins Lymphoma and AML) and Solid Oncology Trials (Ewings Sarcoma, Osteosarcoma, Neuroblastoma and Germ cell tumours). Experience extends to Adult Breast, Prostate, Sarcoma, GI and melanoma cancer trials.

• To co-ordinate and conduct phase II and III clinical trials. To contribute to in-house, commercial and non-commercial national and international clinical trials.

• Ensure approved trial protocols are adhered to according to current legislation, GCP to maintain patient safety and wellbeing.

• Involvement in the set-up process of trials, including investigator meetings, local feasibility reviews, site selection and site initiation visits.

• Identify eligible patients and counsel on trials objectives, rationale, treatment schedule and follow up process. Assist in obtaining consent in line with GCP, screening and the confirming patient’s eligibility to proceed with the trial.

• Perform trial specific patient clinical tasks, including collection of vital signs, review and collection of adverse events, urinalysis, ECG, blood collection, processing and shipping of trial samples. (additionally, adult + paediatric first aid trained)

• Educate wider team on study data and outcomes via presentations, posters and at local/national conferences.

• Worked on General, Oncology, Urology, A&E, Cardiac, Outpatients and Acute (Mental Health) wards.

• Comply with all statutory and legal requirements including Health & Safety and all aspects of the Care Standards Act.

• Provide personal care support. Monitor patients physical state (inc. vital signs, check condition of skin, ECG, urinalysis etc)and mental well-being using NEWS score system.

• Completed care documentation and monitored patient progress to achieve up-to-date records.

• Haematology Team (Multiple Myeloma)

• Ensure maintenance of essential trial documentation, in addition to generating processes by which source information is captured in line with our local standard operating practice e.g. proformas, adverse event logs

• Responsible for data management of trials including data input, query resolutions and review, data verification across various databases + paper formats (InForm, Medidata Rave, Bioclinica)

• Participate in development of the department e.g., taking an active role in internal audits, standard operating procedure committee, which help to identify and review systems/lack of systems in place.