Associate Director, Clinical Data Management - Animal Health

Job Description

Job Overview: We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity, consistency, and confidentiality of data collected during laboratory challenges and clinical field trials. This role involves close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of our clinical research operations.

Key Responsibilities:

- Lead Data Management Initiatives: Direct the development and maintenance of comprehensive databases designed to collect and retain clinical data pertinent to laboratory challenges and clinical field trials for veterinary pharmaceutical and biologic compounds.

- Integrity Checks: Develop and execute comprehensive edit checks to maintain the integrity and consistency of data.

- Discrepancy Management: Collaborate with Clinical Research Managers to resolve complex data entry discrepancies and differences effectively.

- Data Analysis and Reporting: Partner with Clinical Research Managers and Clinical Research Assistants to analyze data findings, troubleshoot issues through effective data queries, and communicate results with Investigator sites.

- Data Tracking and Transfers: Manage the tracking and seamless transfer of external data to the primary database or data warehouse systems.

- Innovative Process Development: Drive the development and implementation of innovative processes to enable paperless studies through an Electronic Data Capture system.

- Stakeholder Collaboration: Foster cooperative relationships with a diverse range of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals.

Key Attributes:

• Proven ability to lead and manage comprehensive data management processes.

• Skilled in implementing and optimizing Electronic Data Capture systems.

• Familiarity with CDISC CDASH/SDTM standards for data collection and reporting.

• Proficient in database entry systems.

• Strong knowledge of GCP and GLP.

• Thorough understanding of clinical research and clinical trial methodologies.

• Strong regulatory knowledge, including FDA/CVM, EMA/CVMP, and VICH guidelines.

• Excellent strategic planning and execution capabilities.

• Exceptional interpersonal, negotiation, and communication skills.

• Proficient in delivering impactful presentations to diverse audiences.

Required Experience:

• Bachelor of Science (or international equivalent) in Data Management, Management Information Systems (MIS), Biological or Clinical Sciences, or a related field.

• Minimum of 5 years in the pharmaceutical industry, specifically within a data management capacity.

• At least 2 years of demonstrable experience in a people management role.

• Expertise in Prelude software or similar dedicated data management applications.

• Comprehensive understanding of regulatory regulations and company procedures.

• Ability to work independently while contributing positively to a project team environment.

• Proficient in English, with excellent verbal and written communication skills.

• Proactive, flexible, and capable of performing well under pressure.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected