Clinical Operations Specialist - II (Associate)
American Cybersystems, Inc.

Job Description: Responsible for independently coordinating all activities associated with timely packaging, labeling, and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies. This individual is responsible for execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress, and review of documentation and procedures. Label Room Specific Responsibilities: Core Responsibilities: • Read comprehend and translate clinical trial protocols /packaging specifications into clinical label generation software. • Design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the Merck label systems. Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs. • Coordination of Translation Requests • Generation of Clinical Label Proofs with CLPG • Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, revise translations, update regulatory requirements, etc. • Maintain Label Translations library. • Interpret clinical study design and Clinical Supply Strategy (CSS) • Design and verify label models. • Coordinate MLBL manufacturing at vendors • Perform visual inspection and accountability for label proofs. • Provide detailed analysis of issues and collaborate for creative problem solving. • Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders. • Train Label Project Coordinator Level I team members and remain proficient in appropriate systems and software. • Responsible for ensuring scheduling and timelines are maintained. • Coordinate with key stakeholders to maintain schedule adherence and maintain key metrics. • May utilize SAP, CSLS, CLPG, eShopFloor, CSST Appian, Microsoft Office, Excel Additional Responsibilities: (including but not limited to) • Adhere to dress code policy. • Complete all the trainings as required. • Complete GMP documentation • Contributing to or author SOPs, CJAs, BTDs, and Job Aids • Contribute to or author investigations. • Contribute to or define and manage CAPAs. • Report potential quality events, non-conformance to GMPs/SOPs when observed. • Generate Change Control/Change Management records. • Manage Re-Packaging and R.E.D. Extension packaging jobs, including drug salvage operations. • Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies packaging and participates in adjustment of logistics pertaining to drug supply.

Responsibilities: Responsible for independently coordinating all activities associated with timely packaging, labeling, and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies. This individual is responsible for execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress, and review of documentation and procedures. Label Room Specific Responsibilities: Core Responsibilities: • Read comprehend and translate clinical trial protocols /packaging specifications into clinical label generation software. • Design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the Merck label systems. Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs. • Coordination of Translation Requests • Generation of Clinical Label Proofs with CLPG • Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, revise translations, update regulatory requirements, etc. • Maintain Label Translations library. • Interpret clinical study design and Clinical Supply Strategy (CSS) • Design and verify label models. • Coordinate MLBL manufacturing at vendors • Perform visual inspection and accountability for label proofs. • Provide detailed analysis of issues and collaborate for creative problem solving. • Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders. • Train Label Project Coordinator Level I team members and remain proficient in appropriate systems and software. • Responsible for ensuring scheduling and timelines are maintained. • Coordinate with key stakeholders to maintain schedule adherence and maintain key metrics. • May utilize SAP, CSLS, CLPG, eShopFloor, CSST Appian, Microsoft Office, Excel Additional Responsibilities: (including but not limited to) • Adhere to dress code policy. • Complete all the trainings as required. • Complete GMP documentation • Contributing to or author SOPs, CJAs, BTDs, and Job Aids • Contribute to or author investigations. • Contribute to or define and manage CAPAs. • Report potential quality events, non-conformance to GMPs/SOPs when observed. • Generate Change Control/Change Management records. • Manage Re-Packaging and R.E.D. Extension packaging jobs, including drug salvage operations. • Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies packaging and participates in adjustment of logistics pertaining to drug supply.

Qualifications: Title: Operations Planner-II Education: High School/Associate degree/Bachelor's degree/Master's degree. Work Experience Requirements: • 3-5 years' experience in the pharmaceutical industry and/or clinical supply knowledge. • Knowledge of GMP guidelines. • Pharmaceutical industry experience. • Label design experience. Preferred Experience and Skills: • Strong verbal and written communication skills. • Detail oriented. • Direct work experience with SAP is a plus. • Flexible and team oriented. • Diligent and quality oriented. • Structured and proactive working attitude. Note: Hybrid role: 4 days onsite/1 day remote. Work location: West Point,PA. Do not submit PHD candidates.