Phase Forward is a leading provider of integrated data management solutions for clinical trials
and drug safety. We are dedicated to helping pharmaceutical, biotechnology, and medical device
companies bring needed drugs and therapies to market faster and more safely. Phase Forward
offers proven solutions in electronic data capture (EDC), clinical data management (CDM), and
adverse event reporting (AER).
Summary of Position:
The Clinical Design Consultant delivers quality eClinical trial design, development, and
consulting to our pharmaceutical, biotechnology, medical device, and CRO clients. The
successful candidate will have responsibility for a variety of clinical trial functions at
Phase Forward, including eCRF design and development, preparation of edit check and test plan
specifications for clinical trials, development of trial extract specifications, custom report
specifications and laboratory upload specifications.
• Contribution toward the development and maintenance of Work Instructions
• Design and Development of eCRFs
• Design and specification of edit checks and rules
• 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 delivery schedules
• Manage customer dialogue for acknowledgement, ownership, commitment, and follow-through
• Design of trial data extract specifications for multiple database configurations including
Clintrial, Oracle Clinical, and SAS
• Provide consulting to clients regarding use of the Phase Forward technology in Electronic
• Must feel comfortable in a fast-paced, team-based environment
Works independently (after training) on less complicated projects, progressing over time to
work on more complicated projects. The emphasis is on quality delivery by focusing on the key
aspects of the job and features of the Phase Forward product line. Provides innovative
solutions to problems based on unique clinical trial requirements. Must work well with the
delivery team. Must be detail-oriented and deliver highest quality services.
Able to review and understand very complicated clinical trial protocols. Is able to make
quality decisions and guide customers through recommendations based on near-expert knowledge
of all products. Provide input to cross-departmental teams to improve product function and
product quality. Able to apply clinical knowledge to technical solutions. Able to manage
deliverable timelines for the QC group.
Technical Skills/Experience: Basic understanding/familiarity with software products such as MS
Word, Excel, Project, PowerPoint. Working knowledge of Internet technology. Understanding of
processes used in Clinical Data Management; clinical trial CRF design, workflow associated
with the management of Clinical Trials and the drug/medical device development process.
Ability to manage projects and deliverables.
Education and Experience Required:
• 3-5 years experience in multiple aspects of clinical trials including but not limited to
data entry, study management, data management and/or clinical operations
• Working understanding of GCP and other regulations associated with clinical trials data
• Knowledge of clinical database structures and implementation
• Experience with design and implementation of automated, complex, database validation checks
• General knowledge of clinical operations and the drug/device development process
• Experience design and specification development for CRF, query text, edit checks, rules
• Presentation, teaching and or consulting skills for customer management
• Ability to manage multiple tasks and project deliverables
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.
Previous experience with consulting, training and/or presentation skills strongly desired.
Travel expectation up to 20%
Phase Forward Incorporated is an Equal Opportunity Employer.
Note to Employment Agencies: Phase Forward does not accept unsolicited resumes from employment
agencies that are sent to any of its addresses or individual employees. Phase Forward is not
responsible for any fees related to resumes that are unsolicited.