Senior Manager, Data Management

Bracco Diagnostics Inc.; Princeton (KY); On-site; USD 140,000 - 210,000; Full time

Job summary

Bracco Diagnostics Inc. is seeking a Sr. Manager, Data Management to lead data management activities for Bracco Group’s global development projects across phases 1–4.

You will plan, lead, and execute data management tasks within cross-functional teams, ensuring high-quality, GCP-compliant databases and timely deliverables. The role requires 7–10 years in pharma data management, strong communication, and the ability to work unsupervised.

Qualifications

• 7–10 years of Data Management experience in pharmaceutical/biotechnology industry.
• SAS programming experience strongly preferred.
• Previous experience with imaging agents is desirable.
• Broad knowledge of Data Management requirements and best practice; demonstrated data management skills.
• Good communication skills, both written and verbal, and attention to detail.
• Ability to work in a team atmosphere and excellent organization/management skills.
• Professional use of the English language; both written and oral.
• Ability to work unsupervised.

Responsibilities

• Lead data management activities for clinical study or a series of related studies with minimal supervision.
• Provide input and review for protocol, Case Report Form, off-site methodology, eCRF specification, Statistical Analysis Plan, Tables/Listings/Figures, and Clinical Trial Reports.
• Oversee all aspects of data management activities from study startup to study close.
• Develop and review approval of EDC/eCRF (considering CDASH principles/standards), Data Validation Plan, Data Management Plan, UAT, etc.
• Conduct data review, query management, audits, and database lock.
• Ensure the final database is clean, GCP compliant, and ready for statistical analysis.
• Review/ manage approval process for adverse events coding, concomitant medication coding, medical history coding (if applicable), and SAE reconciliation.
• Manage data delivery specifications for external data (e.g., LAB, ECG, blinded read, etc.).
• Develop RFPs, establish vendor timelines, manage vendors.
• Monitor vendor progress against specifications and timeline.
• Manage documents through internal review process and provide vendor comments.
• Maintain frequent/effective dialogue with vendor for timely deliverables.
• Manage activities to minimize out-of-scope work (budget management).
• Communicate all relevant information effectively (internally and with CRO team).
• Manage electronic and hard copy filing of essential documentation.
• Ensure SOPs are followed, and contribute to SOP and standard development.
• Support process improvements and assist in evaluation of alternate vendors.

Skills

Data Management

SAS programming

Cross-functional

Communication skills

Leadership

Attention to detail

Education

Bachelor's degree in scientific/healthcare field

Master's degree preferred

Tools

EDC/eCRF knowledge

Job description

Bracco Diagnostics Inc. is a subsidiary of Bracco Imaging which is part of the overall Bracco Group. The Company specializes in the clinical development, marketing and sales of diagnostic contrast imaging agents. Bracco Diagnostics Inc. primarily markets its products to hospitals throughout the United States. Bracco Diagnostics Inc. is committed to the discovery, development, manufacturing and marketing of imaging agents and solutions aimed at providing better diagnostic efficacy, patient safety and cost effectiveness. The Sr. Manager, Data Management is responsible for overseeing data management activities for Bracco Group’s global development projects across phases1–4. Serving as a key member of cross‑functional teams, this role plans, leads, and executes data management tasks with minimal guidance. The position requires strong expertise in data management and broad knowledge of the overall drug development process. The Sr. Manager, Data Management will be responsible for performing the data management activities that support Bracco group’s worldwide development projects. He/she will participate as an active member of a multi‑disciplinary team to plan, lead and execute all the Data Management tasks required for phase1–4 studies. The Sr. Manager/Associate Director is expected to have broad knowledge of the drug development process and strong knowledge of the data management process and can perform most required tasks with minimal guidance.

Responsibilities

• Lead data management activities for clinical study or a series of related studies with minimal supervision.
• Provide input and review for protocol, Case Report Form, off‑site methodology, eCRF specification, Statistical Analysis Plan, Tables/Listings/Figures, and Clinical Trial Reports.
• Oversee all aspects of data management activities from study startup to study close.
• Develop and review approval of EDC/eCRF (considering CDASH principles/standards), Data Validation Plan, Data Management Plan, UAT, etc.
• Conduct data review, query management, audits, and database lock.
• Ensure the final database is clean, GCP compliant, and ready for statistical analysis.
• Review/ manage approval process for adverse events coding, concomitant medication coding, medical history coding (if applicable), and SAE reconciliation.
• Manage data delivery specifications for external data (e.g., LAB, ECG, blinded read, etc.).
• Develop RFPs, establish vendor timelines, manage vendors.
• Monitor vendor progress against specifications and timeline.
• Manage documents through internal review process and provide vendor comments.
• Maintain frequent/effective dialogue with vendor for timely deliverables.
• Manage activities to minimize out‑of‑scope work (budget management).
• Communicate all relevant information effectively (internally and with CRO team).
• Manage electronic and hard copy filing of essential documentation.
• Ensure SOPs are followed, and contribute to SOP and standard development.
• Support process improvements and assist in evaluation of alternate vendors.

Knowledge, Skills, and Abilities

• 7–10 years of Data Management experience in pharmaceutical/biotechnology industry.
• SAS programming experience strongly preferred.
• Previous experience with imaging agents is desirable.
• Broad knowledge of Data Management requirements and best practice; demonstrated data management skills.
• Good communication skills, both written and verbal, and attention to detail.
• Ability to work in a team atmosphere and excellent organization/management skills.
• Professional use of the English language; both written and oral.
• Ability to work unsupervised.

Education

Bachelor’s degree (Master’s Degree preferred) in a scientific/health care field preferred.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity

Bracco Diagnostics Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, or any other protected status.