Clinical Trial Manager

  • Regular/Permanent
  • USA / Texas
  • Managers/Engineers and executives
  • Full-time Regular (REG)
  • Day job

Welcome to Orano

Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.

Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.

Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 16,500 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.

Job description

Orano Med:

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.
 

 

Our Full-Time Benefits

  • Competitive compensation 
  • Health, Dental, and Vision insurance – with generous employer contributions 
  • 401(k) with employer matching and contribution amounts 
  • Life insurance and Short- and Long-Term Disability insurance provided by the company
  • Generous Paid Time Off and holiday schedules 
  • Numerous Training and Development opportunities 

Ideal qualifications

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. 

 

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. 

Clinical Trial Manager

Ref: 2022-10465

Regular/Permanent

Plano

Managers/Engineers and executives

ORANO-USA

Orano Med LLC

Orano Med, a major player in Targeted Alpha Therapies

Based on its unique expertise in the extraction and purification of lead-212 (212Pb) and radiolabeling technologies, Orano Med is developing innovative 212Pb-based treatments which consist in selectively destroying cancer cells while limiting the impact on surrounding healthy cells.

With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for 212Pb, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches.

2 high-purity production units LMT in France (Laboratoire Maurice Tubiana) and DDPU in the USA (Domestic Distribution and Purification Unit)

Find out more about Orano Med
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