Job Description

Responsibilities:

• As required, contribute to the development of a Trial Master File (TMF) Plan, conduct ongoing and final Quality Control (QC) checks of TMF for sections owned by the Clinical Project Manager (CPM); providing Contract Research Organization (CRO) with queries/feedback to ensure correctness and completeness of documents and of TMF overall.
• Utilise TMF intelligence (reports and dashboard) to guide the assessment of TMF Health.
• Provide support to Program Delivery Lead (PDL)/CPM for setting-up studies in the UCB Clinical Trial Management System (CTMS), provide information to CTMS team to ensure data fields owned by UCB are kept up to date. Conduct ongoing and final QC checks of the UCB CTMS, liaise with CRO/CPM to provide feedback and ensure resolution of issues.
• Liaise between Clinical Research Organization (CRO), CPM, Study Physician, Quality Lead and Legal on local Informed Consent questions and ensure fast resolution.
• Provide support for Clinical Outcome Assessments (COA), liaising with CPM and other stakeholders.
• Responsible to manage the Letter of Authorization (LOA)/Delegation of Authority (DOA)/Power of Attorney (POA) process and obtain LOA/DOA/POA signatures for Global Clinical Sciences and Operations (GCSO).
• Manage Activity Notification Form (ANF) process and reconciliation for study specific activities as applicable (e.g. Data Review Boards, Key Opinion Leaders interaction), and process e-payment requests.
• If applicable, request the set-up of shared repositories for studies and ensure access management.
• Creation of the Study Team list, and management of study SOP listings, and the periodic updates.
• Request and review the aggregate financial reports for studies managed by CPM from UCB Compliance and highlight any significant payments to PDLs and CPMs. Assist PDLs and CPMs with documenting due diligence to mitigate potential bias.
• In collaboration with CPM and Global Quality, support audit/inspection activities to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
• Drive the implementation of new technologies/systems in clinical trials managed by GCSO.
• Act as subject matter expert on UCB systems and continue to find efficiencies between UCB systems and CRO systems (e.g., CTMS, TMF, Source Quality, SharePoint, Microsoft Teams).
• Participate in the Joint Clinical Study Team (JSCT) meeting and other Clinical Study Team /trial-related meetings where CTA expertise is required. If not outsourced to CRO, assist the CPM to prepare, distribute and file agenda and meeting materials as required.
• Support CPM tasks at a study level to facilitate study outcomes for planning, initiation, maintenance and close out milestones.
• Contribute to process improvement initiatives and share best practice experience with Line Manager and/or CPM as appropriate.
• Occasional travel including overnight stays may be required.
• Perform other tasks as deemed necessary by the Company.

Qualifications (minimum):

Bachelor's Degree

Master's Degree

Ph.D.

Law (J.D.)

Medical Degree (M.D.)

Other (Describe): Bachelor's Degree or equivalent work experience in a clinical development work environment required.

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