Senior Manager, Data Management

Bracco Medical Technologies • Princeton, NJ

96d

About The Position

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 a better use and management in terms of 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 phases 1–4. 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 phase 1-4 studies.

Requirements

• 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 practices; demonstrated data management skills.
• Good communication skills, both written and verbal, with 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.

Nice To Haves

• Master’s Degree in a scientific/health care field preferred.

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, Clinical Trial Reports.
• Responsible for all aspects of data management activities from study startup to study close.
• Responsible for development, review approval of: EDC/eCRF, Data Validation Plan, Data Management Plan, UAT.
• Responsible for data review, query management, audits and database lock.
• Ensure that 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 and SAE reconciliation.
• Manage data delivery specifications for external data, for example, LAB, ECG, blinded read.
• Develop requests for proposals (RFPs), establish vendor timelines, manage vendors.
• Monitor vendor progress against specifications and timeline.
• Manage documents through the internal review process and provide comments to vendor.
• Maintain frequent/effective dialogue with the vendor to ensure timely deliverables.
• Budget Management (manage activities to minimize out-of-scope work).
• Communicate all relevant information effectively (both internally and with CRO team).
• Manage the electronic and hard copy filing of essential documentation.
• Ensure that standard operating procedures are followed.
• Contribute towards development of SOPs and standards.
• Support process improvements.
• Assist in evaluation of alternate vendors.

Benefits

• Equal opportunity employer.
• Commitment to improving lives through prevention and precision imaging.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1-10 employees