Sr. Manager/Associate Director/Director of Data Management
New Today
Key Attributes:
The Associate Director / Director of Clinical Data Management is an exceptional hands-on, highly detail-oriented, innovative, and collaborative leader that possesses the ability to work closely with cross functional colleagues to ensure effective, timely, high-quality data support for clinical development deliverables across the company's portfolio. The ideal candidate will have a proven record of success in clinical data management, strong leadership skills, and a deep understanding of regulatory requirements and industry standards.
Essential Responsibilities:
- Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Statistical Programming, and Regulatory Affairs to ensure data management activities support overall clinical trial objectives.
- Manage the data management timelines, budgets, and resources to ensure the successful and timely delivery of data.
- Develop and implement data management strategies that align with project goals and regulatory requirements.
- Oversee the planning, design, and execution of data management processes, including data collection, cleaning, and analysis.
- Lead and mentor junior clinical data management team members, fostering a collaborative and high-performance environment.
- Ensure data management practices comply with FDA, EMEA, and other relevant regulatory requirements and industry standards.
- Oversee the preparation and submission of data management documentation for regulatory submissions and audits.
- Ensures all data management work is performed consistent with quality in accordance with Good Clinical Practices (GCP)
- Identify opportunities for process improvements and implement best practices in clinical data management.
- Evaluate and leverage modern technologies and tools to enhance data management efficiency and effectiveness.
- Oversee relationships with external data management vendors and ensure their deliverables meet quality and timeline expectations.
- Manage contracts and performance metrics for outsourced data management services.
- Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines.
- Acts as clinical data management subject matter expert for internal and external stakeholders.
Requirements
Education:
- Bachelor's or Master's degree in Life Sciences, Data Management, Information Technology, or a related field.
Experience:
- 10+ years of experience in data management within the pharmaceutical, biotechnology, or CRO industry.
- Proven track record of managing data management activities for clinical trials, including database design, data validation, and data cleaning.
- Experience in leading and developing a team of data management professionals.
- Strong understanding of regulatory requirements and guidelines related to clinical data management.
- Experience in oncology therapeutic area
Skills:
- Expertise in data management systems (e.g., EDC systems such as Medidata Rave, Oracle Clinical) and data management processes.
- Excellent communication and presentation skills, with the ability to convey data management concepts to diverse audiences.
- Strong problem-solving skills and the ability to work effectively in a fast-paced, dynamic environment.
- Leadership abilities with a focus on team development and performance management.
- Ability to work in a fast-paced and dynamic environment.
Salary Description: $120k - $230k
Salary Description
$120k - $230k
- Location:
- San Diego