Senior Manager, Data Management

Position Summary:

This role will be responsible for oversight of outsourced data management activities and be charged with developing data management oversight and data cleaning processes and a CRF library.

Major Duties and Responsibilities:

• Oversee outsourced data management activities by ensuring the design, development and maintenance of clinical databases meets regulatory requirements and industry standards and developing and monitoring key performance indicators (KPIs) for data management service providers.
• Ensure timely and appropriate reconciliation of external data sources against clinical databases on assigned studies.
• Collaborate with cross-functional teams including Clinical Operations, Biostatistics and Clinical Development to ensure high quality and on time delivery of study level data.
• Collaborate with internal stake holders to develop an internal data review process.
• Manage internal data review process and issuing / resolution of queries.
• Develop global CRF library for re-use on future studies to improve study database build timelines.

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...

All candidates must meet the following minimum requirements in order to be considered for this opportunity.

Minimum Qualifications:

• Bachelor's degree in life sciences, computer science or related field.
• Experience with database design in oncology clinical trials using RECIST V1.1 response criteria.
• At least 7-10 years in data management, with at least 3 years as lead data manager.

Differentiating Qualifications:

• Advanced degree.
• Experience with database design in radiopharmaceutical clinical trials.
• Experience with database design for studies using prostate cancer working group 3 (PCWG3) response criteria.
• Prior relevant experience within leadership or management role.

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.