Strategic Outsourcing Project Manager - Clinical Supply

As a Strategic Outsourcing Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This is a remote role. Individual needs to reside in the East Coast time Zone. 

Must have Project Managment Pharmaceutical packaging and Labeling experience, vendor managament experience in Clinical Supplies or a packaging company that works in Clinical Supplies/CRO. 

What do you need to have?

• Packaging and Labeling background in Clinical Supplies.
• Will own a compund and take it from start to finish. 
• Vendor or negotiations experience.
• Serve as member of clinical study team and/or clinical drug supply team, as assigned
• Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy
• Support design and set-up of IVRS system
• Support financial planning for global clinical supplies, including  budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline
• Coordinate the origination, proofing and translation of clinical study labels, as required
• Monitor global clinical supply inventory at the clinical site level for both IVRS and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly
• Coordinate drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs, as required
• Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
• Serve as ‘consultant’ for managers throughout the organization on issues related to clinical supplies and project management

Education and Work Experience:

• BA/BS degre required.
• PharmD degree or oither advanced degree nice to have
• Pharmaceutical Product Knowledge required.
• 2-4 Plus years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred

Knowledge, Skills, and Abilities:

• Working knowledge of the Clinical Trial Supply process
• Working knowledge of project team structure and processes
• Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
• Knowledge of project management and Clinical customer relationship building
• Knowledge of the ‘Customers’ team structures and processes
• Excellent verbal and written communication skills
• Ability to influence others
• Ability to multi-tasks
• Strong organizational skills
• Experience in conflict resolution and negotiation skills
• Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint, MS Project and Access

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.