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 Clinical Trial Manager for its clinical trials. The Clinical Trial 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 Clinical Trial Manager functions with general 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.
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher level position.
• Bachelor's degree in life/physical sciences or nursing.
• Ability to assess the inherent risks of a situation, their potential impact on a project and based on this information, independently make timely decisions.
• Ability to prioritize, organize, plan and follow-through with multiple projects.
• Strong communication and interpersonal skills.
• Working knowledge and experience with Word, PowerPoint, and Excel.
• Ability to travel minimum of 20%.
INDUSTRY REQUIRED QUALIFICATIONS
• Minimum of five years of clinical research experience.
• Previous trial management or project management experience at a sponsor or CRO.
• Pervious experience with registrational oncology trials
• Phase 1-3 oncology clinical trial experience
• Strong GCP and regulatory knowledge including FDA and ICH regulations.
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.