SRG, the leader in the Life Sciences human capital industry, is looking for a Manager, Global Clinical Supply to join our team.

Location: Remote (must be able to travel to Connecticut occasionally, approximately once per month)

Contract: 12 months

Qualifications & Skills:

• Minimum 5 years of related pharmaceutical industry experience
• Successful track record in investigational drug services (preferably in the biotech space)
• Demonstrated experience in global inventory management and forecasting
• Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance documents
• Ability to prioritize and deliver on tight timelines
• Outstanding problem-solving abilities
• Detail-oriented, with strong organizational and project management skills
• Strong oral and written communication skills
• Proficient with MS Word, PowerPoint, Excel
• Strong leadership, project planning, negotiation, and presentation skills
• Significant experience communicating/presenting complex information to senior management and regulatory agencies
• Ability to multi-task and manage several projects in parallel
• Ability to forge cross-functional working relationships
• Proactive in identifying and resolving issues

Education:
BS/BA degree or PharmD with prior clinical supply, hospital, or investigational drug service experience (preferably in a biotech environment)

Responsibilities:

• Assist CMC with contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product)
• Lead planning, creation, and maintenance of IMP supply project plans, based on study forecasts
• Manage development and implementation of IVRS supply and drug return strategy
• Manage Clinical Supplies inventory for assigned projects
• Interact with clinical sites, caregivers, and patients regarding supply needs, storage, and return
• Ensure key supply project milestones are met; negotiate and communicate supply plan timelines
• Drive cross-functional activities and manage complex projects
• Represent Clinical Supplies on global clinical project teams
• Assist Associate/Director Head of Clinical Supply with forecast planning and real-time inventory management
• Identify process improvement opportunities and drive implementation
• Actively manage deviations, clinical supply investigations, CAPAs, and Change Control documentation
• Ensure compliance with SOPs and regulations

Must Have:

1. Prior IRT (IxRS) experience (Interactive Voice/Web Response System experience in clinical trials or pharmaceutical operations)
2. Review batch records
3. Vendor oversight

Only candidates selected to move forward in the recruitment process will be contacted to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.