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Remote Clinical Trial Material Manager needs B.S./B.A. in Science or Engineering or Business with 3+ years in-line experience in biopharmaceutical industry
Remote Clinical Trial Material Manager requires:
• Minimum of 3-5 years of relevant clinical trial materials management experience in either the biotech, pharmaceutical or contract research organization arenas.
• The candidates must have demonstrated project management skills, including oversight of contract resources, and proficiency in management of CTM labeling, packaging, disbursement, shipment, and inventory procedures.
• Knowledge of electronic systems used to track and manage CTM inventory for clinical trials.
• Ability of budgeting and financial management at project level is a must.
• Intimate knowledge of GCP, GMP, GDP, U.S. IND, NDA and ICH regulations is required.
• Therapeutic experience and knowledge in any of the following areas is desired, but not mandatory: respiratory/pulmonary, CNS and oncology.
Remote Clinical Trial Material Manager duties:
 Supports clinical studies by ensuring personalized CTM is available to study subjects when and where is needed.
 Forecasts study level drug product needs, pack and label design and supply chain logistics planning for all phases of clinical trials.
 The CTMM Manager will consult on clinical study protocol, operation and site training for CTM supply management.
• Provide support to aggregate and quantify future requirements for clinical trial materials into a comprehensive supply/demand forecast at a study level, to develop CTM project plan and integrate the plan with clinical trial timeline by conducting capacity planning and inventory control to create a supply chain logistics and distribution plans.
• Manage distribution/logistics activities of supply chains by evaluating subject screening and enrollment progress, tracking inventories, tracking expiry dates, initiating shipments, coordinating import/export requirements. Coordinate set up/planning/end-user testing/ of Interactive Response Technology IxRS (e.g. IVRS or IWR and/or CIMS) in line with study needs. Ensure integrity of all clinical supply chain management databases used for managing clinical trial requirements.
• Identify the most suitable CMO and initiate contracts. Oversee work assignment and deliverables for CTM suppliers and collaborate on and review of pre- and post-executed batch records to ensure timely completion of CTM milestones and internal development work. Manage and track CTM vendor contract, purchase orders, work orders, and invoices.
• Consult on clinical study protocol, suitable CTM development and supportive stability plan, comparator sourcing, and clinical site selection. Conduct CRA training for CTM supply management.
• Contribute with initiatives to support the generation, refinement, and maintenance of CTM supply infrastructure. Comply with ICH, Federal U.S. and any pertinent local regulations, such as GCP, GMP and GDP, and adhere to SOP and Guidance.
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Reference : Remote Clinical Trial Material Manager, PAYS $72/HR jobs

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Published at 22-05-2022
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