Orano
Senior Clinical Project Manager
Orano, Boston, Massachusetts, us, 02298
Regular/Permanent
USA
Remote Options
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 17,000 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.
Position Summary:
The Senior Clinical Project Manager is responsible for project management and oversight of assigned clinical trials.
Position Responsibilities:
Oversight checks including monitoring report review and TMF checks.
Status meeting attendance, meeting minute review/taking.
Invoice review, confirmation of services received.
Support CRO with site level issues including non-compliance, etc.
Review data cleaning metrics, address backlogs.
Review or create/amend study level documents including ICFs, protocols, study plans, training materials, etc.
Provide study status updates.
Manage study to budget and timelines.
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
and more…
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.
Minimum Qualifications:
Bachelor's degree in life/physical sciences or nursing.
10-12 years, with at least 3 years of experience as a CTM / Clinical Trial Project Manager.
Differentiating Qualifications:
Previous experience working with a CRO.
Skills/Knowledge:
Knowledgeable in ICH GCP, applicable US regulations, project management and clinical operations, study budgets and timelines.
Knowledgeable on platforms including Medidata RAVE, clinical trial management systems, excel, etc.
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.
#J-18808-Ljbffr
USA
Remote Options
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 17,000 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.
Position Summary:
The Senior Clinical Project Manager is responsible for project management and oversight of assigned clinical trials.
Position Responsibilities:
Oversight checks including monitoring report review and TMF checks.
Status meeting attendance, meeting minute review/taking.
Invoice review, confirmation of services received.
Support CRO with site level issues including non-compliance, etc.
Review data cleaning metrics, address backlogs.
Review or create/amend study level documents including ICFs, protocols, study plans, training materials, etc.
Provide study status updates.
Manage study to budget and timelines.
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
and more…
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.
Minimum Qualifications:
Bachelor's degree in life/physical sciences or nursing.
10-12 years, with at least 3 years of experience as a CTM / Clinical Trial Project Manager.
Differentiating Qualifications:
Previous experience working with a CRO.
Skills/Knowledge:
Knowledgeable in ICH GCP, applicable US regulations, project management and clinical operations, study budgets and timelines.
Knowledgeable on platforms including Medidata RAVE, clinical trial management systems, excel, etc.
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.
#J-18808-Ljbffr