Senior Clinical Data Manager Or Director For A Medical Device Company
(Los Angeles, California)

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This Fortune 100 Medical Device Client has asked us to find them a Senior Clinical Data Manager and/or Director, and/or a Biostatistics Manager for a Southern California Location. We have placed many happy and satisfied candidates with this company. They are a group that "Works hard and Plays hard".

The Manager or Director is responsible for managing the efforts of data management and biostatistics staff in support of US and international clinical trials, and for ensuring that data activities are conducted in accordance with regulatory and company standards. This position interfaces closely with the divisional Clinical Research groups and Project Teams to facilitate new and continuing R&D initiatives.

Some of your responsibilities would include:

• Manage the Data Management/Biostatistics department • Make hiring decisions and allocate resources • Involved in study design and determining how fits with device and marketing capability.

• Provide input on training tool for clinical • Improve quality of core lab data • Review statistical analysis plans, final report templates and reports, proposals by outside vendors.

• Take an active role in assisting Clinical Research to define their strategy for clinical trials in support of product development.

• Provide support to the Clinical Data Project Managers on sections of clinical research protocols requiring biostatistical consideration including endpoint specification, study logistics, sample size, determination/justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules (if applicable).

• Manage the overall effort of the Clinical Data Management/Biostatistics group to ensure quality clinical trials.

• Interface with outside biostatisticians and other professionals when external expertise is required.

• Interface with CRO management to ensure quality of their data management and biostatistics activities.

Minimum Requirements & Experience:

• Minimum of a Masters degree (US), in biostatistics, basic science or health field.

• Minimum of 5 years experience with clinical data management and biostatistics.

• Minimum of 5 years management experience.

• Demonstrated project and people managerial skills.

• Experience with statistical software packages (SAS) and database systems.

•Must be able to work in a fast paced, high energy environment, and have the ability to prioritize, focus on details, provide solid leadership, and understand how to motivate a great team. To be considered, send your resume (As a Word Document) in confidence to the attention of Jim Clark: Email: themillenniumgroupus@yahoo.com

Full Relocation, bonus, 401K, benefits, etc, provided.