Clinical Trials Designer

A client of mine in Waltham, MA is seeking a Clinical Trials
Designer. They are the pioneer in proven eProcess solutions for
accelerating global pharmaceutical development. They use Internet
technologies to conduct and manage clinical trials efficiently,
delivering quality data, faster database lock, and faster time-to
peak sales for approved products. They offer a dynamic environment
with competitive salaries and abundant opportunities for learning and
growth.

The successful candidate will have responsibility for a variety of
clinical trial functions, including eCRF design and development,
preparation of edit checks and validation plan, development of trial
extract specifications, reports, laboratory uploads, and Clintrial
design and development.

Responsibilities will include:
Development of Work Instructions and SOPs
Design and Development of eCRFs
Design and specification of edit checks
Design and development of Clintrial databases and user interfaces
Work with the study team and client to design the best possible
eSolution for the trial
Work with the study team to plan resources and setup timelines
Manage customer dialogue for acknowledgement, ownership, commitment,
and follow-through
Design of database specifications
Must feel comfortable in a fast-paced, team-based environment

The position requirements are:
3-5 years experience in multiple aspects of clinical data management
Working expertise of GCP and other regulations associated with
clinical data
Experience with laboratory, pharmacokinetic, safety and/or efficacy
data
Knowledge of clinical database structures and implementation
Experience with implementation of automated, complex, database
validation checks
Experience with data review, data coding and other data cleaning
activities
Experience with SAS, Clintrial expected
Experience writing and editing SOPs as well as validation a plus The
successful candidate will have a record of proven leadership, will
possess excellent written and verbal communication skills, will be
self-motivated, able to work independently, and will be looking to
make significant contributions in an entrepreneurial environment.
Travel expectation up to 20%

What do you think? If you are interested in pursuing this
opportunity,
please forward to workwonders@...:

-your resume in word or text format
-your salary requirement
-your US work authorization

If you aren't interested or feel you are not qualified, do you know
anyone who would be interested? We do offer generous referral fees.

Thanks for your time and have a great day!