Coding Specialist – Boston

Company Information:

Breakthrough Careers!
A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

As a Coding Specialist, codes all applicable clinical trial data with standardized terminology and participates in the development of database standards and data management procedures that relate to clinical data coding.

Duties and Responsibilities:

Compares and reconciles adverse event data captured in Product Safety with adverse event data captured on case report forms.

Codes adverse events, concomitant medications and other data as needed using standardized terminology (e.g., MedDRA, WHODRL).

Develops coding conventions for MedDRA for coding data other than adverse events (e.g., Medical History, Physical Exam data, etc.).

Participates in the development and enforcement of Coding Policies in conjunction with Product Safety, Regulatory Affairs, Clinical Research, Medical Writing and Biostatistics.

Designs and produces data listings for review of the accuracy, completeness and consistency of clinical trial coded data in conjunction with Clinical, Product Safety and Biostatistics.

Works in conjunction with the Data Manager to specify database edit checks and follow data discrepancy resolution procedures for coded data.

Monitors timelines to ensure deadlines are met for data calls and database lock activities.

Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Process Guides related to coding activities.

Qualifications:

MS/BS degree in health-related field (RN or RPH preferred); 3+ year(s) of clinical data management experience in the pharmaceutical/biotechnology industry; knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; clinical experience in the oncology, inflammation and cardiovascular field desired.

Other qualifications include: attention to detail, excellent written, verbal and organizational skills and expertise using WHOART, WHODRL, MedDRA.


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