Senior Manager, Data Management

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 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. 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.

Essential Activities, Duties, Tasks and Responsibilities

• Be able to 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 (taking into consideration of CDASH principles/standards), Data Validation Plan, Data Management Plan, UAT etc. Also 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 (if applicable) and SAE reconciliation.

• Manage data delivery specifications for external data, for example, LAB, ECG, blinded read, etc.

• 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

• supervisory Responsibilities - none

Required Knowledge, Skills, and Abilities

• 7-10 years of Data Management experience in pharmaceutical/biotechnology industry

• SAS programming experience strongly preferred

• Previous experience imaging agents is desirable.

• Broad knowledge of Data Management requirements and best practice; demonstrated data management skills

• Good communication skills, (written and verbal), 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/heath 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.

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.