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.

We are currently looking for a suitable candidate to come on board to our Medical Biometrics team for a Manager/Sr. Manager, Data Management position (depending on the experience and skill level either position could be considered).

• 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

• 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.
• Monitoring 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 – 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
• Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform Data Management tasks and interact with vendors.
• Previous experience with imaging agents is desirable.
• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance’s, CDISC CDASH, SDTM standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Strong project management skills and a proven ability to multitask
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent communication skills, (written and verbal)
• Professional use of the English language; both written and oral.
• Ability to multi-task, deal with competing priorities, meet aggressive timeline expectations.
• Ability to think clearly, be customer focused, get appropriate input from different disciplines as needed, provide focused answers.
• Team player who is cost conscious, adaptable to change, excellent organization skills, quality focused, accountable, with proven analytical and problem-solving abilities.
• Taking personal responsibility to achieve results/objectives and makes every effort to achieve the expected outcome of any task.
• candidates with 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/heath 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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