For one of our clients, we are looking for a Data Analyst to provide support to the Clinical Supply Integration staff. We are looking for someone with a first experience in clinical research and excellent computer skills.
- Do you have experience as CTA, Data reviewer, Trial Supply Assistant or other related functions?
- Do you feel comfortable working with databases and computer systems?
- Do you have a good knowledge of GXP?
- Are you results and performance driven, without loosing attention to details?
Then don't hesitate to apply soon!
This role will provide support to the Clinical Supply Integration staff, as well as fostering strong, productive relationships with colleagues within the Clinical Supply Chain organization and its stakeholders. This person will be responsible for processing, tracking, and filing of study documents within the clinical projects. Next to that, he/she supports project managers within the assigned clinical studies.
- Under general supervision, accountable for the timely processing and tracking of study essential documents for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
- Prepare and coordinate review and approval of Distribution Plans for all new Clinical Trials.
- Proactively request new clinical trials to be added to Distribution database
- Create Distribution Plan, coordinate review meetings with depots/CSIs, make updates to plan and route for approvals, review distribution quotes and prepare for CSI review, route final quotes for approval and initiate PO process. Communicate PO numbers to all depots and ensure all approved versions of Distribution Plans are posted in appropriate repository.
- Coordinate 3rd Party Requests
- Obtain SMPC and post in appropriate repository
- Create requests for technical documents on CSI sharepoint site follow up with expert team to ensure timely completion
- Ensure sharepoint site is kept up to date with TD numbers as well as status
- Manage sharepoint for changes as needed
- Single Point of Contact for Quality Events for CSI team
- Attend weekly quality meetings to provide updates on CSI owned records
- Follow up with CSI team (as needed) to ensure timely completion of records
- Once trained, act as SPOC for all records for CSI (Open, pre-populate, manage) and then work with impacted CSI to add issue specific content
- Develop system to manage processes within CSI team:
- Track upcoming periodic review and notify team
- Routing updates to WIs/SOPs through docspace and gaining approvals
- Create standard set of training material to be used across CSI team for all process updates.
- Assist with management of the following items on behalf of the CSI team:
- Obtaining release documents/bulk lot information for filings/CSRs
- Sample shipment tracking for development work
- CSI sharepoint maintenance/changes/enhancements
- Perform Quality Review in vTMF
- Complete Temperature Intake Form on behalf of CSI
- May be involved in other tasks to support Clinical Supply Integration as needed.
- Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word, Power Point and Sharepoints).
- Good knowledge of clinical research and operations
- Good knowledge of GXP
- Minimum 80% FTE required for the job
- Results and Performance Driven
- Big Picture Orientation with Attention to Details
- Ability to collaborate internally and have seamless partnership
- Ability to work in cross cultural environment Very good knowledge of the English language.
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