Clinical Operations Specialist

3 weeks ago


West Point, United States Collabera Full time
Job DescriptionJob Description

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: 

• Strong verbal and written communication. 

• 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 onsite/1 day remote. Work location: West Point,PA.  

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 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, 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. 

 

 

Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.

  • West Point, United States Collabera Full time

    Job DescriptionJob DescriptionQualifications: 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. •...


  • Cherry Point, United States American Operations Corp. Full time

    Conduct classroom instruction, simulator training, and practical flight exercises to prepare personnel for operational fleet squadron assignments. Assist in the development and refinement of training curriculum and course materials to ensure alignment with USMC aviation requirements and objectives. Assess aviator performance and proficiency through...


  • West Chicago, United States Ball Horticultural Company Full time

    Create and manage delivery downloads and shipping priorities to production sites and communicate inventory and shipment delays to customers in a timely, accurate, and effective manner to provide customers fast notification of challenges and optimal a Operations Specialist, Operations, Sales Representative, Specialist, Customer Service, Manufacturing,...


  • West Point, United States Merck Sharp & Dohme Full time

    **Position Overview - Basic Functions & Responsibility** **The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area,...


  • Point Pleasant, United States Pediatric Specialty Care Full time

    Salary: $24.64/ hr $36.96 / hour Overview: The Clinical Scheduling Specialist generates, manages and updates master schedules for the nursing department while making adjustments as needed according to budgetary constraints, census fluctuations, attendance tracking, benefit accrual entries, and leaves of absence. We are seeking someone who is detailed...


  • West Point, United States Intelliswift Full time

    Sample Processing Specialist - II (Associate) Job ID: 24-02739 Qualifications: Educational background at a minimum - Associate's Degree in the sciences or related field with 4yrs in the pharmaceutical or related industry / Bachelor's Degree in the sciences or related field with minimum of 2 years in the pharmaceutical or related industry * Strong...


  • Point Pleasant, United States ElderwoodPediatricPostAcuteWoodmark Full time

    $24.64/ hr – $36.96 / hour The Clinical Scheduling Specialist generates, manages and updates master schedules for the nursing department while making adjustments as needed according to budgetary constraints, census fluctuations, attendance tracking, benefit accrual entries, and leaves of absence. We are seeking someone who is detailed oriented, highly...


  • West Point, United States Community Counseling Services, Inc. Full time

    Vacancy No VN921 Vacancy Name Community Support Specialist Work Location West Point Main Office Application Post Date Apr 22, 2024 Location NotesEmployment Type Full Time Work Schedule M-F 8am - 5pm; ability to handle emergency after hours as they arise Description Service Delivery Expectations: 1. Provides $67,000 collected service delivery annually. 2....


  • West Reading, United States Customers Bank Full time

    Guarantee assigned wire transactions from all channels, foreign currency payments, customer service, wire investigation/research, and reconciliations are done in a complete and timely manner and are in line with all policies and procedures, establish Operations Specialist, Operations, Specialist, Wire, Customer Service, Diversity, Manufacturing, Banking


  • West Union, United States Nutrien, Ltd. Full time

    Ship, receive, verify, and process orders Remove products or inventory to and from large trucks, stack, shelves and maintain organized inventory in order of need Clean and sweep facility Prepare documents, bills of lading and shipment paperwork Blend Operations Specialist, Operations, Seasonal, Specialist, Manufacturing, Agriculture


  • Point Pleasant, Pennsylvania, United States Pediatric Specialty Care Full time

    Salary: $24.64/ hr – $36.96 / hour Overview:   The Clinical Scheduling Specialist generates, manages and updates master schedules for the nursing department while making adjustments as needed according to budgetary constraints, census fluctuations, attendance tracking, benefit accrual entries, and leaves of absence. We are seeking someone who is...


  • Point Pleasant, Pennsylvania, United States Pediatric Specialty Care Full time

    Salary: $24.64/ hr – $36.96 / hour Overview:   The Clinical Scheduling Specialist generates, manages and updates master schedules for the nursing department while making adjustments as needed according to budgetary constraints, census fluctuations, attendance tracking, benefit accrual entries, and leaves of absence. We are seeking someone who is...

  • Quality Specialist

    3 weeks ago


    West Point, United States The Fountain Group Full time

    Job DescriptionJob DescriptionPay range: $35-41.78/hrContract: 1 year (possibility for extension or conversionJob Description:Provided day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing...


  • West Chester, United States Aventura Health Group Full time

    Aventura Health Group -   Aventura Health Group is seeking an experienced Director of Clinical Operations for its skilled nursing facilities in Pennsylvania. In this role, you will be reporting to the Director of Operations and will work closely with the clinical management team to implement clinical policies and procedures. The responsibilities will...

  • General Dentist

    3 weeks ago


    West Bridgewater, United States DCS Clinical Full time

    Job DescriptionJob DescriptionTitle: General DentistLocation: West Bridgewater, MAPosition: Part-time permanentSchedule: Tues. 8-6 PM, Wed. 8-5 PM, Fri. 8-4 PM*Any mix of these days but Wed. is a must!Our client is seeking a longterm General Dentist to join their team in providing exceptional comprehensive dental care to patients. The ideal candidate focuses...


  • West Point, United States Independent Insurance Agents of Nebraska Full time

    Summit Ag Insurance is a fast-growing agency with a client-focused approach to crop and farm insurance. We proudly serve the Midwest agricultural community with our unique integration of insurance and technology. Our dedicated team is excited to be growing again! As a Client Data Specialist you will quote homes and autos, enter data, and play an essential...


  • West Valley City, United States Extra Space Full time

    At Extra Space Storage, what matters to you, matters to us! Join a company that cares about you. It is an exciting time to be at Extra Space. We have been featured on multiple "Best Places to Work" awards, including Forbes and Glassdoor. We're an S&P 500 company that hasn't stopped growing since our founding in 1977. Today we are leading the self-storage...


  • West Palm Beach, United States SpecialtyCare Full time

    Minimally Invasive Clinical Specialist I SpecialtyCare is expanding! We are currently looking for the right candidate to start and train as a Minimally Invasive Clinical Specialist I (MIS) to work in and around the Operating Room. SpecialtyCare provides multi-stage training programs involving personalized, hands-on learning from in-person educators,...


  • West Lebanon, United States Ledyard National Bank Full time

    Job DescriptionJob DescriptionThe Bank Operations Specialist II is responsible for the day-to-day servicing of customer accounts. This position will process both deposit and loan related items that are handled by the Operations. This position will be responsible for answering customer calls to resolve issues or answer any questions. This position will work...


  • Point Pleasant, United States Pediatric Specialty Care Full time

    Salary: $150,000 / Year Overview: Pediatric Specialty Care serves technology dependent, medically complex children with varying and often multiple diagnoses and treatment levels. Our inpatient facilities are built to provide a lively environment for both short-term and long-term needs. In addition to clinical care, we provide rehabilitation, education and...