Project Manager

InterSources Inc. is a certified IT consulting and services company. The Project Manager will assess, configure, and manage complex RTSM study designs while supporting clinical development, supply strategy, SOPs, deviations, inspections, and process improvements.

Responsibilities:

• Assess planned studies for suitability for RAMOS RTSM system
• Independently configures and manages/maintains complex RTSM study designs, possibly those with an international or more complex design, adaptive design, etc
• Proactively identify and communicate issues as well as provide proposed solutions
• May be RTSM group business point of contact for technical systems (Randomization and Container Code, Packaging, and Shipping Systems)
• Responsible for drafting, amending, & determining gaps in SOPs
• Raise Deviations/Customer Complaints and associated CAPAs. Assist with Helpdesk during daytime hours, when needed, in addition to participating on Helpdesk Stand-by/On-Call rotations (nights, weekends, holidays)
• Accountable for identifying, owning, and implementing process improvements and training needs & gaps
• Provide technical guidance/support to Clinical Development for their outsourced RTSM studies
• Develop supply strategy to eliminate stockouts, minimize waste and reduce shipments
• Support inspections and all operational actions supported by studies

Requirements:

• Scientific degree or equivalent experience
• Minimum of 3 years related experience in building studies in RTSM
• Ability to lead project improvement initiatives
• Understanding of the development process and clinical supplies
• Ability to maintain accurate records and files in accordance with GSK policy, cGMPs, and SOPs
• Proven computing skills & experience with various software: Excel, Word, Powerpoint, Visio, MS Project, etc
• Proven ability to work in a matrix team
• Ability to work independently
• Should be detail-oriented and possess the ability to handle multiple tasks
• Ability to train others inside and outside the workgroup in area of expertise
• Experience in working with customer relations
• Must exhibit excellent oral and written communication skills
• Good interpersonal skills
• Good planning and coordination skills
• Creative and innovative thinking
• Strong problem-solving skills
• Drive for continuous improvement