Note: The job is a remote job and is open to candidates in USA. InterSources Inc is a Small, Woman, and Minority-Owned Business Enterprise with over 18 years of experience in providing IT Consulting Services. They are seeking a Project Manager to assess and manage complex RTSM study designs, ensuring effective communication and problem-solving throughout the project lifecycle.
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
Skills
- 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
Company Overview