Bracco Diagnostics Inc.
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. The company is committed to the discovery, development, manufacturing, and marketing of imaging agents and solutions aimed at providing better use and management in terms of diagnostic efficacy, patient safety, and cost-effectiveness.
Job Opening: Manager/Sr. Manager, Data Management
Note: We may consider a suitable candidate with solid clinical SAS programming experience and good knowledge/experience of clinical data management.
Job Purpose
The Manager/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 Manager/Senior Manager 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
- 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.
- 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.
- Monitoring vendor progress against specifications and timeline.
- 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 the evaluation of alternate vendors.
Supervisory Responsibilities
N/A
Required Knowledge, Skills, and Abilities
- Minimum 5 years of Data Management experience in pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience.
- Strong project management skills and a proven ability to multitask.
- Excellent communication skills, both written and verbal.
- Team player who is cost-conscious, adaptable to change, excellent organization skills, quality-focused, accountable, with proven analytical and problem-solving abilities.
Candidates with the Following Knowledge, Skills, and Abilities May Be Considered
- Minimum years of solid clinical SAS programming experience, mapping and creation of legacy, SDTM, ADaM datasets, sdrg, define.xml, pinnacle validation; review of SAP TLF shells, integration of ISS, ISE and experience with regulatory submission with strong data management knowledge and willing to grow and take on data management tasks with some minimal guidance.
Education
Bachelor’s degree (Master’s Degree preferred) in a scientific/health care field.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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. The position is home office based with no travel requirements.
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.
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