Position Details

ASSOCIATE DIRECTOR, DATA MANAGEMENT

Associate Director, Data Management
Full Time Direct Hire
Salary is DOE (target is ~150-170k + 20% bonus + stock options)
San Diego, CA 92121 (onsite ~1-2 days a week, the rest remote; ~10% travel)

Summary:
The Associate Director, Data Management will oversee the data management of our clinical trials. Will provide oversight to the daily operations of our clinical programs through vendors. Will facilitate effective internal and external relationships. Will be expected to contribute extensively to the development and growth of the Data Management group within the Clinical Operations structure.

Responsibilities:
• Oversee the data management of all clinical trials.
• Develop and implement methods to demonstrate oversight of CROs and other vendors.
• Provide direction and leadership in CRO and vendor selection and management.
• Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Protocols, Centralized Monitoring Plans, etc.) and trial conduct.
• Ensure that the Data Management component of the TMF and other documentation required to support regulatory submissions and inspections are maintained to the standard required.
• Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence.
• Contribute to strategic planning to ensure optimized use of data management resources within the area of responsibility.
• Participate in and/or lead the development and implementation of standards and processes related to both clinical data and risk-based trial management.
• Participate in the generation and approval of budgets and timelines.
• ~10% national travel.

Required Skills / Experience:
• Heavy Clinical Data Management for the pharmaceutical/biotechnology industry and experience in an FDA-regulated environment.
• Thorough knowledge of data management and its role in the drug development process.
• Understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data management.
• Experience of all stages of a clinical trial and vendor oversight.
• Demonstrated knowledge of ICH/GCP guidelines as they relate to data management.
• Thorough understanding of CDISC CDASH and SDTM standards.
• Extensive experience managing CROs and other data vendors.
• BA/BS required, preferably in the scientific/healthcare field.
• Experience working with a globally distributed team is desired.

Soft Skills:
• Problem Solving - Uses logic and methods to solve difficult problems with effective solutions. Looks beyond the obvious and doesn’t stop at the first answer.
• Decision Quality - Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment. Most solutions turn out to be correct and accurate when judged over time.
• Teamwork/ Interpersonal Savvy. Relates well to all people, both within and outside of the Company. Builds an appropriate rapport and constructive relationships. Uses diplomacy and tact.
• Priority Setting – spends time on what’s important. Eliminates obstacles and understands what it takes to accomplish a goal.
• Flexibility/ Dealing with Ambiguity - Effectively copes with change. Can decide and act without having the total picture, doesn’t have to finish things before moving on. Comfortably handles risk and uncertainty.

Company/Benefits:
• Cutting Edge Biologics Cancer Treatment Company
• In business over 10 years
• Recently went public
• 35 employees
• Bonus
• Stock options; and in process of implementing ESPP
• Very strong Medical and Dental
• Unlimited PTO
• 401k
• Life and Disability Insurance


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