Job Category: Pharmaceutical & Biotech

Sr Dir Clin Database Ops & Standards (DG)

Job Location: Morris Plains, NJ (see all jobs in NJ)

Work Type: Hybrid

Date Posted: 2022-01-28

Senior Director Clinical Database Operations and Standards (DG)
Clark Davis Associates - Morris Plains, NJ
Position can be partially remote
Up to $220,000 base plus 25% bonus & Stock valued over 100K

SUMMARY:
Small biotech in the Northern NJ area is seeking a Senior Director to establish Database Operations and Clinical Standards as a key component of the Data Acquisition and Strategic Operations function. This includes strengthening and aligning activities and capabilities to increase efficiency of database build and compliance to CDISC, while implementing industry standards.

RESPONSIBILITIES:
Create a center of excellence focused on database development specifications and data standards compliant with CDISC. Develop, maintain and implement governance of global library standards with a view toward re-usability and data integration. Develop medical coding approach that will allow for data consolidation across multiple EDC systems. Coordinate and align data structure with external organizations. Support the functional development of a risk management plan for audits with a goal of being inspection ready. Prioritize and develop scalable capabilities that will allow for future growth with a view toward identifying core/non-core activities and a plan to retain those of strategic importance in-house. Liaise with IT to identify, acquire, develop and maintain systems to support Data Acquisition & Strategic Operations including organizing and leading change management initiatives with broad impact. As needed, accountable for the management and development of teams including performance management and career development. Key strategic member of the Data Acquisition and Strategic Operations Leadership Team. Proactively anticipate problems, identify root causes and implement creative solutions. Collaborate effectively with other functions. Responsible for development and monitoring of performance metrics. Support VP in development of CRO sourcing strategy (including core/non-core definition) specific to Database Operations & Standards; actively work towards improvements over time that drive improvements in time, cost and quality. Participate in Study Team meetings as needed. Author, review and approve Database Operations & Standards related SOPs and Working Practices. In collaboration with IT and Biometrics, participate in the development and maintenance of the statistical computing environment to support global usage. Oversee the creation, maintenance, and validation standards for programming tools, outputs, and macros. Supervisory Responsibilities: Potential supervision of Database Operations and Standards staff.

QUALIFICATIONS:
Bachelor’s degree in Life Sciences or related from accredited college or university. Advanced degree preferred.
Minimum of 10 plus years experience in database programming. Minimum 7 years of line management and project team leadership experience, as well as process management and innovation. Prior experience with clinical trials leading to NDA submissions. Experience leading technical cross-functional system and process initiatives required. Strong communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers. Knowledge of FDA/ICH guidelines and industry standard practices regarding data capture, clinical data structure, relational database, data processing, analysis programming, and data exchange with alternate formats. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation. Computer skills: detailed knowledge of multiple data management systems, basic familiarity with SAS datasets and conversion procedures. Understanding of the requirements for electronic data capture, SDTM, ADaM, Data Definition Table, and e-submission. Knowledge of statistical terminology, clinical tests, medical terminology and protocol design. Experience managing database developers/programmers. Proficient in programming languages / software. Advanced knowledge of reporting tools and database design practices. Solid understanding of clinical data and pharmaceutical development. Ability to research new technologies and ensure alignment with regulatory agencies and industry standards.

Please contact Darren Gutowski at dgutowski@clarkdavis.com

Up to 220K Base+Bonus+Stock

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