Senior CDM Technical Specialist in Boston, MA

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:

Summary Description of Job:

Administer and support the Clinical Study build process at a protocol level, providing technical expertise. Develop a knowledge base of clinical application support, and the broader activities associated with clinical trials.

Duties and Responsibilities:

Detailed Responsibilities and Scope of Job:

Perform specific development work in support of clinical application development, including but not limited to:

database setup
creation and testing of data entry screens
programming of data edit checks,
loading data from external sources (e.g., laboratories, EDC vendors).

Make decisions on design and management of assigned protocols.

Coordinate activities with other departments, CROs and other consultants with minimal supervision.

Manage vendors providing services in relation to above activities.

Mentor less experienced staff.

Trouble shoot issues relating to:
EDC study build/design
EDC Integrations

Participate in the development of departmental documentation including SOPs, Work Instructions, Best Practices, and user requirements specifications.

Align priorities to meet timelines, with guidance as needed.

Evaluate new application releases and patches and participate in their implementation.

Actively engage in team problem solving and notification (e.g. proactively informs team of potential delays in timeline, independently schedules meetings as needed, etc).

Qualifications:

Basic Qualifications:

BS degree in computer science with four or more years of relevant experience, MS degree with two or more years relevant experience, or the equivalent.

Must be familiar with the InForm and InForm Architect as well as Cognos reporting.

Preferred Qualifications:

Two or more years experience directly related Study Build activities and familiarity with EDC systems and associated processes per FDA and ICH requirements is preferred.

Knowledge of RDBMS

Documentation skills.
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