CliCs Project Manager Pharmaceutical


Logistics Distribution and Supply Chain

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Branch Information

Swiftwater, PA - (USA) 1 Discovery Drive PA Swiftwater , PA 18370



Job Description

This position supports project management linked to the new CliCS application that will be deployed for CSCO teams.

He/she will be in charge of:

- organize and participate in User Acceptance Tests (UAT) as test leader

- organize and participate with training sessions for end users with the support of the application provider.

- Participate in Quality Document (QD) review and writing as QD coordinator

- Participate with the project core team meeting as Great Valley representative

This position requires an high level of knowledge in processes especially within areas of packaging and labelling operations for investigational products, clinical supply chain management systems (packaging, manufacturing and distribution) and master data management within these types of systems.

In depth knowledge of GxP regulations, training methodology and project management on transversal topics. In depth knowledge of pharmaceutical packaging and distribution processes and documentation. Effective in communicating with peers and management. Must be detail oriented with very good written communication and computer skills and with strong problem solving skills. The individual in this position must be creative, be able to make process proposals, be able to make decision, and convince others on decisions. Ability to be autonomous in the project management, ability to make good founded, rational decisions, good teamwork, good organizational skills are all important. Strong Project Management is required. Leading a Matrix Team is essential.

The individual must be well versed in all aspects of the clinical supply chain processes, GxP and other regulatory requirements.

Experience with MS Office Suite (Excel, Word, PowerPoint, Visio, SharePoint, MS Teams, Outlook), ERP, flow diagram creations.

. Knowledge And Skills Desirable But Not Essential:

Ability to read/write/speak French language is desirable but not mandatory

E. Major Duties & Responsibilities

1. Testing

* Organize testing sessions with relevant testers

* Participate to testing sessions

* Ensure reporting and feed back to the global test leaders

2. Quality Documentation

* Ensure that changes /to be processes impacting CSCO are well incorporated in QDs.

* Coordinate review and revision of QDs.

* Ensure documentation complies with regulations; local country requirements.

3. Training

* Organize, lead and / or participate in training sessions

* Ensure interface(s) with the creators of the training materials

* Ensure training for of all end impacted users until proficiency is established.

. Major Challenges/Problems:

Ensure the processes are the same in all CSCO sites when appropriate.

Make sure that all individuals have comprehensible and accurate knowledge of the CSCO processes and that they are trained before Go-Live.

Regular: Entire CSCO, local and global SQO, external partners (suppliers such as solution providers)

Decision Making Authority

Authority to harmonize, to simplify or improve common/local process with respect of regulation, to develop training material for new or updated processes related or not related to solutions.

Authority to Propose new initiatives allowing some improvement of the Clinical supply Chain Operations.