Senior Clinical Project Manager
USA / Texas
Published on 2/23/2024
Job reference : 2024-15654
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
OranoMed is seeking a Senior Clinical Project Manager for its clinical trials.
The Senior Clinical Project Manager is responsible for the oversight of assigned clinical trials and associated activities ensuring that they are executed, conducted, and completed in accordance with corporate goals and objectives, applicable regulations, and Standard Operating Procedures (SOPs).
The Senior Clinical Project Manager functions with minimal supervision, collaborating with inter- and intra- company resources to ensure quality performance and that project timelines and needs are being met. Main responsibilities include:
• Evaluate and oversee the activities required to execute, conduct, and complete clinical trials while managing to the established timelines and corporate budgets.
• Function as primary liaison for vendor personnel, site personnel, and internal personnel regarding trial related topics and/or questions.
• Negotiate site budgets and contracts.
• Collaborate with cross functional team members (e.g., pre-clinical, manufacturing, data management, safety surveillance, biostatistics, and quality assurance).
• Manage trial start-up activities by providing input in protocol development, case report forms (CRFs) and study related material and independently developing the Informed Consent (IC).
• Develop, implement, and ensure adherence to the monitoring plan for assigned trials.
• Ensure the collection, accuracy, and storage of trial related documents.
• Oversee trial monitoring activities for assigned trials and personally conduct site visits as needed.
• Conduct regular team meetings, assigning action items and due dates, as applicable.
• Review and track monitoring reports for content, quality, adherence to GCP and timely submission.
• Identify obstacles and related solutions and implement plans, in collaboration with the study team, to ensure the trial objectives, scope and timelines are being met.
• Develop Corrective and Preventative Action (CAPA) plans for issues of non-compliance.
• Track, measure and report the status of project milestones.
• Assist in the development and implementation of clinical Standard Operating Procedures and associated tools.
• Other duties as assigned.
Intern - Radiopharmaceutical Manufacturing
USA / Indiana
Published on 2/23/2024
Job reference : 2024-15653
The Intern – Radiopharmaceutical Manufacturing will participate in the establishment of ATLab Indianapolis as a new commercial-scale manufacturing facility for therapeutic radiopharmaceuticals. During Summer 2024, the facility will be concluding construction and qualification, so the Intern should focus efforts on: safety and occupational training, completing an assigned project, helping with basic tasks, growing in technical understanding, developing workplace skills, and building a professional network.
Safety and Compliance
Read and follow all assigned relevant SOPs
Safety: Reading/on-the-job training in radiation safety, hazardous materials, occupational safety.
Assist with submissions and compliance for RAM license and environmental compliance.
Production, QC, Shipping
Observe/assist with qualification of spaces: IQ/OQ/PQ of cleanrooms and aseptic spaces
Assist with qualification (IQ/OQ/PQ) of new equipment and instrumentation.
Observe and understand: function of all instrumentation; chemistry behind production of Pb-212 and radiolabeled final drug product; science behind all QC methods.
Assist with implementation of new software: inventory management, chemical inventory, eBR, LIMS, dose ordering, shipping software, etc.
Consumable supplies: assist with inventory management, including planning, purchasing, inspecting, and accepting incoming supplies.
Assist with design and implementation of shipping equipment and procedures.
Embody and promote a culture of quality and continuous improvement.
Adhere to all applicable procedures, cGMP, company policies, and any other quality or regulatory requirements.
Learn about and gain comfort with cGMP and QMS.
Assist with preparing and reviewing documents: SOPs, vendor qualification forms, material acceptance forms, instrument qualification forms, etc.
In consultation with the supervisor, the Intern is expected to identify and complete a project with reasonable scope during the period of the internship.
Amount: 1-3 optional travel opportunities
The intern may receive other tasks and responsibilities as assigned.
Published on 1/2/2024
Job reference : 2023-14208
Orano Med is seeking a Senior Buyer (new job position) to oversee and manage all purchasing activities on a commercial scale for Orano Med LLC locations.
This role can work out of our Plano, TX office or Brownsburg, IN office.
Ensure the correct realization of the Supply Chain objectives (planning, quality and costs)
Manage the panel of local suppliers: Identify and propose new suppliers and manage relationships with local suppliers.
Effectively communicate with Purchasing team, Departments, and external vendors (Supply Chain, Project Management).
Bring expertise and support to the Project/Facilities Managers (supplier selection, correct execution of the contracts)
Support all the functions within the purchasing process.
Deliver reports to upper management
Recommend updates for best practices.
Resolve obstacles on the full Supply Chain Process (internally and externally)
Negotiate with vendors on best offers and on contracts.
Support the Purchasing Director:Identify local vendors
Organize and structure within Purchasing department
Annual Budget forecasting for Purchasing department.
Scope of purchasing activities: equipment and services for all the facilities and the pharmaceutical activities in US.
Management of the Purchasing Performance on the scope of responsibilities
Manage U.S. Purchasing team
Manage the Supply Chain activities for the region (management of the call for tenders, negotiation with suppliers, contract negotiation and execution).
Provide guidance and feedback to Purchasing team
Location: On-site 70%, travel 30%