Administrative support to Clinical Project Managers (e.g. managing facilities, logistics of meetings, document management and archiving, meeting minutes, maintenance of local processes/online systems related to compliance and purchasing/payment, support for the reconciliation of activities
Coordinate the stamping process for the study relevant activities/documents
Develop TMF Plan, conduct ongoing and final QC checks of TMF for sections owned by GCPM; providing CRO or Partner with queries/feedback to ensure correctness and completeness of documents and of TMF overall.
Provide support to COL/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 Partners/CPM to provide feedback and ensure resolution of issues.
Liaise between Partners, CPM, Study Physician, QA and Legal on local Informed Consent questions and ensure fast resolution.
Check UCB Data Standard COA Repository and liaise with CPM and OC to identify vendors and obtain licensing agreements.
Responsible to manage the Letter of Authorization/Delegation of Authority/Power of Attorney process and obtain LOA/DOA/POA signatures for GCPM.
Manage Activity Notification Form (ANF) process and reconciliation for study specific activities that is out of scope for the Partner (e.g. Data Review Boards, KOL interaction).
Request the set-up of study mailboxes for all studies and ensure access management.
Request and review the aggregate financial reports for studies managed by GCPM from UCB Compliance and highlight any significant payments to COLs and CPMs. Assist COLs and CPMS with documenting due diligence to mitigate potential bias.
Perform spot checks on Site Regulatory Packages (SRP), Form FDA1572s and PI CVs as necessary.
Drive the implementation of new technologies/systems in clinical trials managed by GCPM.
Act as subject matter expert on UCB systems and continue to find efficiencies between UCB systems and Partner systems (e.g. IMPACT, TMF, Mikado, U Pilot, SharePoint).
In collaboration with CPM, support audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
Participate in Clinical Study Team meetings and/or other trial-related meetings when their specific expertise is required.
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.
Required qualifications
Good verbal and written English and local language skills
Excellent communication skills and attention to detail
Highly proficient in MS Office Suite
Ability to rapidly learn new tasks and skills
Strong organizational and time management skills
Preferred scientific and technical skills
Knowledge of GCP and ICH Guidelines, FDA and/or EU regulations
Positive attitude towards Change Management
Basic knowledge of medical terminology
Ability to work on multiple concurrent assignments
Ability to work independently and manage own workload
Ability to work in an international team environment
Ability to be creative and flexible and function in a fast paced environment
Ability to proactively analyze and challenge processes and propose solutions
Able to liaise and discuss with internal and external stakeholders
Able to identify and create efficiencies to support the delivery of UCB portfolio
Ability to learn and master new technologies and systems and train colleagues on technologies and systems
Remark: The contract would be 1-2 year contractor with CIIC.
