BACKGROUND

Seattle Genetics is currently seeking a Clinical Data Management professional to fill the position of Clinical Data Operations Manager.

RESPONSIBILITIES

This position will oversee the data management related tasks within Clinical, including supervising Clinical Data Associates and SAS Programmers. The Clinical Data Operations Manager will interact with in-house clinical/regulatory staff and with outside data management vendors/CROs. This person will be responsible for the review and development of vendor contracts as well as management of current vendor relationships. The Clinical Data Operations Manager will ensure consistency in Case Report Forms and database structures across studies. This person will act as the administrator of the clinical trial data along with Biostatistics. The Clinical Data Operations Manager will be responsible for the maintenance of coding dictionaries. This person will establish data management SOPs and Guidelines. Minimal travel will be required.

REQUIREMENTS

BS or MS degree and a minimum of 5 years experience in biotechnology/pharmaceuticals in a management position. Solid experience in clinical data management including development of CRFs, data management plans, database design, coding, and generation of clinical study reports in accordance with FDA guidelines is required. Prior SAS programming and EDC experience preferred. Excellent written and oral communication skills are also required. Candidate must be detail-oriented and have excellent supervisory, problem solving, negotiation and organizational skills.

TERMS:
Fulltime

LOCALE:
Bothell, WA

COMPENSATION:
DOE

HOW TO APPLY:
http://seagen.com/careers/index.htm OR scoleman[at]nwrpros.com