Trial country relevant documents set-up (e.g. local CTPs) including BIRDS set-up, formatting check, initiating workflows etc.
Create local signature page
Set up of share point, public drives, Microsoft teams, etc.
Start-up communication (sites)
Enter feasibility tracking information to BI CTMS (as Site Selection Manager)
Site qualification follow up letter submission for filing in TMF staging area
Ethics Interactions
Support to CTM to inform TDS about trial events to trigger document collections from sites
Other activities
- Investigational supplies support - communication and scheduling, obtain Import Licenses as applicable at OPU level (CTM to release green light, CRO supposed to support all other administrative but if not covered by CRO, to be supported by CTA)
Investigational non-drug supply coordination with Clinical Supplies (if not possible by CRO)
Co-ordinate translations of documents after review/translation (approvals, applications, advertising, patient materials, ICFs etc.) and submit for TMF filing
Support for site contract preparation/negotiation/execution (CTM provides template, CRA responsible for site adaptation)
Update BICTMS: add sites; site staff; event dates; ICF versions; applications; initiation checklists; update trial team members
Set up Paper Trial Master File if applicable
2. Support trial during Conduct Site communications
Maintain site contact and relevant vendor and regulatory document tracker (tracking of medical licenses and follow-up/annual collection reminders)
Printing/mailing documents and equipment to sites (if CRA is not responsible for it)
Vendor communication
Support CTM to inform TDS about trial events to trigger document collections for critical documents (eg. Investigator Brochures, signature pages)
Other Activities
Co-ordinating translations of documents after review/translation (approvals, applications, advertising, patient materials, ICFs etc.) and submit for TMF filing
Support CTM to inform TDS about trial events to trigger document collection
Support production and create local signature pages for local/global amendments
Responsible for site address /personnel change, notifications and updates to related forms, supplies, BICTMS updates, and vendor’s spreadsheets etc.
Ordering trial supplies and sending to sites (if CRO cannot support)
Maintain Paper Trial Master File if applicable
3. Support trial during closeout Communication with sites
CTR synopsis submission and tracking to from/sites, Ethics Committees and or Health Authorities, as applicable (whether CRO can take it, considering KR CTR timelines that could take long)
Support off-site archiving of Site ISFs and Pharmacy files
Archiving
Common drive/Shareroom clean-up
Support Paper Trial Master File archiving if applicable
Other activities
Coordinate the collection of equipment from sites (via CRA)
Update BICTMS
4. Other activities as required throughout trial
Audits and inspection support
Assisting trial teams in audits/inspections/CAPAs
Training
Support to verify training records of site staff, and OPU BI Staff (including CRA) for amendments and updated documents (eg. TLMM)
Meetings
Book clinical team meetings
Meeting minutes for clinical team meetings and subsequent distribution to relevant stakeholders (and sending for filing in TMF)
Support together with CTM/meeting planners, investigator meetings
Access and training for all systems for vendors at site level (eg. IRT, ERT, etc. tracking/submission/maintenance of vendor spreadsheets) (In SEASK, site level covered by CRA, but to deliver information to vendors, CTA to support)
- IRT access code envelopes - distribution to CRAs
BICTMS
BICTMS review and oversight, enter event dates, approval dates, ICFs
Completing IDM BICTMS information request forms
Review of site-start up form with IDMs
Enter relevant study/site staff responsibilities, start/end dates
Run reports from BICTMS
Validate/cross-check TMF, TSL, BICTMS information for consistency/completeness
Investigational Study File binders
Localize and co-ordinate translation of trial templates
Maintenance of trial/trial country specific trackers if applicable ( if not supported by CRO)
Other
Document the feasibility tasks in Progress (Initial Interest, Confidentiality Agreement, Feasibility Forms)
Submit TMF documents owned by CTM to TDS
Apply Insurance Certificate on behalf of CTM and make sure that it is up to date (eg. patient numbers/site contacts/duration of insurance coverage)
Organize shipment of paper documents collected
Management of calibration validity of sponsor loaned equipment (in case not supported by CRO)
To support CTM to Inform TDS about trial events to trigger document collections
Support resolution of workflow/filing issues (appropriate issue escalation in relation to documents and vendors)
Upload legal and other functional area documents to staging area for TMF filing according to BI requirements
Manual processing of patient expenses and other trial related expenses (e.g. reimbursement of site staff expenses after an IM)
Act as Payment Manager in BI CTMS
5. No study specific activities (per assignment in Korea; under COA in Singapore)
CO department meeting/gathering/workshop organization and arrangement including gathering of presentation materials in central e-folder
CO organization chart/handover checklist maintenance
Onboarding and off-boarding of CO staff
Coordinate orientation program for new CO staff
CT insurance handling including application, payment, filing of original certificates…
Management of ClinOps paper mail.
PV query mailbox management
OPU specific trial status report maintenance and sharing (e.g. TH trial status update)
Gathering of CTM Monthly Report to Line Manager
Signatory process coordination including DocuSign
Act as Contract Manager/Assistant including filing of confidentiality agreement, CTA, vendor agreements in Cora and central paper file
Contact point for the archiving and archiving vendor
Maintenance of Office Archiving Room including management of master key log
Sharedrive/Sharepoint/Idea for Gen maintenance
Liaise with office administrator for office and administrative matters including ordering of office supplies
Liaise with GBS, Finance, Purchasing for related queries
Consultancy case handling for payment
General vendor management and payment including but not limited to couriers, travel agencies,
- Management of POs (includes site payments or other related ClinOps payments)- Singapore only
- Clin Ops MyBI webpage- Singapore only
- MyShop request for onboarding/termination of CRO staff across SEASK, and maintenance and update of CRO staff list for COVM- Singapore only
- Act as IDM of assigned trial- Singapore only
Job Qualifications :
1-2 years of relevant experience
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