Job Description

Job Description

The Medidata Rave Study Builder will be responsible for creating Rave studies for therapeutic oncology trials. Incumbent will bring experience with study build activities in Medidata Rave, preferably in oncology. Experience using CDASH data elements in order to facilitate SDTM mapping and CDISC compliance is preferred. Salary offered will be based on study build experience.

Responsibilities:

• Designs and develops electronic case report forms (eCRFs) to meet the data collection requirements of oncology protocols in accordance with NCI and ECOG-ACRIN guidelines
• Programs and validates eCRFs, folders, matrices, and edit checks as per protocol-specific criteria
• Develops expertise in advanced clinical and/or technical implementation of Medidata Rave including NCTN integrations
• Works closely with Data Management and Statistical staff to develop eCRFs and prepare edit check specifications
• Performs database maintenance and assists in development of new database applications
• Assists Data Management staff with database troubleshooting
• Manages multiple priorities by assessing needs, adjusting workloads and communicating project status to stakeholders accordingly
• Performs other duties and special projects as assigned

Experience

• Minimum of 1 year of experience in building case report forms (CRFs) using the Medidata Rave electronic data capture (EDC) system. (Oncology experience a plus.)
• Proficiency in Clinical Data Management procedures including knowledge of Good Clinical Practices (GCP)
• Experience in forms development guidelines (NCI and other pertinent organizations) preferred
• Knowledge of CDISC/CDASH standards and/or BO4 reporting a plus
• Excellent written and oral communication skills

Education

• Bachelor's degree from an accredited college or university or equivalent work and/or life experience.

Company Description

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research clinical trials involving adults who have or are at risk of developing cancer. ECOG-ACRIN consists of a headquarters location in Philadelphia, PA., and several fully staffed centers and offices, including an operations office and statistical data management center located in Boston, MA. The ECOG-ACRIN Cancer Research Group is a project of the ECOG-ACRIN Medical Research Foundation

Company Description

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research clinical trials involving adults who have or are at risk of developing cancer. ECOG-ACRIN consists of a headquarters location in Philadelphia, PA., and several fully staffed centers and offices, including an operations office and statistical data management center located in Boston, MA. The ECOG-ACRIN Cancer Research Group is a project of the ECOG-ACRIN Medical Research Foundation