Description:

6 Month Consulting assignment with Spark Therapeutics to act as consulting Director of Data management. Backfill for current Director who is retiring.

Will be providing people management as well as overall vendor management and ensure data management deliverables are met during study lifecycle.

Priority study is a phase iii study in Gene Therapy

Skills:

Clinical development, Data management, Line Management, Clinical Research, Data, Gene Therapy, Rare Disease

Additional Skills & Qualifications:

• Demonstrated expertise in the management of clinical trial data is a must. Prior experience providing data management support in gene therapy, rare disease and/or observational studies is a plus. Working with specialty labs is highly desirable.

• Global clinical trial expertise and a successful track record of leading through influence, working across global organizational matrices.

• Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

• Solid understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

• Well versed in industry trends and emerging technologies concerning data review.

Experience Level:

Expert Level

About Actalent:

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