Associate Director, Clinical Data Management (Hybrid)

Job Description

Global Clinical Data Standards Therapeutic Area Lead

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and contribute to our mission of making a difference in global health.

Responsibilities

• Define standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulations.

• Ensure the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables.

• Lead standards data governance reviews.

• Contribute to the definition and maintenance of business processes related to the definition, use, maintenance, and sharing of clinical data standards.

• Lead or participate in department initiatives, cross-functional working groups, and process improvement activities.

• Participate in cross-functional project teams; establish collaborations/interactions with colleagues outside the department and make frequent contacts external to the area and/or company.

• Maintain knowledge of new technologies, industry standards, regulatory requirements, and our company's guidelines and SOPs.

• Work independently or as a team member with equal effectiveness.

• Interact with staff across multiple company sites.

Qualifications

Required

• B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.

• 8+ years’ work experience which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development.

• Advanced knowledge and leading-edge skills in clinical data standards.

• Study Data Tabulation Model (SDTM) expertise.

• InForm expertise.

• Analysis & Reporting experience.

• Program-level clinical and business requirements knowledge.

• Strong communication and presentation skills.

• Proficient in education, training, and facilitation.

• Must have an innovative spirit, outstanding interpersonal skills, leadership, and demonstrated proficiency in the management of multiple projects.

• Knowledge of clinical data management.

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EligibleforERP

#GDMS

Required Skills:

Adaptability, Adaptability, Business Processes, Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Computer Science, Data Analysis, Data Collection Methods, Data Governance, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Establishing Contacts, Global Health, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Interpersonal Relationships, Mentoring Staff, Multi-Management, Process Improvements, Project Management, Project Management Tools, Regulatory Requirements {+ 2 more}

Preferred Skills:

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 characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: