Data Analyst - Beerse

Data Analyst - Beerse

This role will provide support to the Clinical Supply Integration staff within J&J Pharma R&D, as well as fostering strong, productive relationships with colleagues within the Clinical Supply Chain organization and its stakeholders.

Responsible for processing, tracking, and filing of study documents within the clinical projects.

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.

Non Technical Skills and Additional Details

Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word, Powerpoint and Sharepoints).

Good knowledge of clinical research and operations

Good knowledge of GXP

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.

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.