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Clinical Supply Project Coordinator – US

Caligor Rx

This is a Full-time position in Bastrop, TX posted August 30, 2021.

CLINICAL SUPPLY PROJECT COORDINATOR At Caligor Coghlan Pharma Services we feel good about the work that we do – as a global company, we provide clinical trial services specializing in sourcing of comparator drugs, as well as sourcing, packaging, and labeling for clinical trials worldwide.

We are also engaged in sourcing expanded and early access to medicines.

We pride ourselves in making it our business to find a better way to deliver for our clients.

Our dedicated people care
– about their work, their team, and the results we strive to deliver every day.

If you are looking for a project coordinator position in the world of Clinical Supplies in the Pharma Services area, where what you do and how you do it will make a difference, then this position is for you.

We expect our people to live and work our corporate values of *Integrity*People*Quality*Service*Expertise*Accountability* Position Summary The Clinical Supply Project Coordinator supports the Senior Global Project Manager, the Global Project Manager(s), and the Associate Project Manager(s) in the execution of the activities for clinical research development programs associated with investigational clinical supplies and marketed drugs.

He/she has direct responsibility for day-to-day project tasks to ensure successful completion.

Organizational Position The post holder reports directly to the Senior Global Project Manager, but he/she will work closely with the CSS Business Development team and the Head of Clinical Supply Operations.

Responsibilities * Work on behalf of Caligor Coghlan Pharma Services (CCPS) clients, supporting the Clinical Supply Project Management team in performance of their functions.* Assist in the creation and maintenance of timelines for each project and distribute internally for review and externally, as required.* Support the Clinical Supply Project Management team in client meetings, as required.* Responsible for batch records creation / compilation, approval / signature collection, delivery to Operations and WH team(s), and documentation appropriateness and completeness.* Responsible for interpreting client supplied information, defining requirements, and generating associated documentation to support operational distribution staff in the shipment of finished goods, components, and ancillary items.

* Assist the Project Manager with all tasks associated with the successful management of the distribution and return of clinical trial supplies.* Assist the Clinical Supply Project Management team with all tasks associated with the successful management of inventory and the distribution and return of clinical trial supplies.* Generate instructions for return, accountability, and destruction at CCPS and CCPS contracted depots.* Assist in the preparation of summaries and reports relating to the activities of the department.* Maintain accurate and appropriate records and reference documentation for the provision of internal management information.

* As necessary, conduct administrative duties associated with the position.* Ensure tasks and activities comply with cGDP/cGMP regulations and Standard Operating Procedures (SOPs).* Other related duties as assigned by supervisor.

Qualifications, Experience and Skills Required * Bachelor’s Degree in Biology/Life Sciences or the equivalent combination of education and 2+ years pharmaceutical research experience required.* Ability to organise, plan and prioritise tasks within a high volume, varied workload.* Ability to interpret and apply cGMP and GCP knowledge.* Strong interpersonal skills and the ability to manage, motivate and influence work behaviors.* Proven experience to manage and organize a team.

* Open-minded, empathic, and able to adapt to different cultures among our international clients, investigators, study coordinators and projects.* Flexible, enthusiastic, and highly motivated to work in a challenging environment.* Proficient knowledge of various computer applications
– to include Microsoft Office applications (Word, Excel, Outlook).

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