Business Analyst

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job title: Business Analyst

Location: Lawrence Township,NJ

Duration: 6+ Months

Job Description:

Provide system administration tasks for global medical information system, including but not limited to: testing PI's, adding quick codes, adding & maintaining system dictionaries & drop-down lists, creation of header (images), signature images as well as ad hoc reports from within the application query tools. Provide system administration for medical information system.

Minimum of High School Diploma required

Proficient computer skills required (MS Word, Excel, PPT)

Excellent communication skills required

Knowledge of medical terminology preferred

Attention to detail a must

Ability to perform Business administer tasks within SalesForce.Com

Competent Business process knowledge of Investigator Initiated Trials / Investigator Sponsored Studies

Familiarity with Agile Project management

Project Management skills a plus

Serves as Key Subject Matter Expert for change management activities within the clinical trial business capabilities and associated system/technology.

Support in the development, execution, and monitoring of the system/technology Business Plan in collaboration with key stakeholders.

Partners with R&D functions, internal and external on implementation, and oversight of new and existing platform capabilities.

Responsible for the development of system and reporting requirements for the Clinical Trial Business Capability in partnership with IT colleagues

Support activities for system/technology performance, project budget, stakeholder communications/change management.

Lead training and communication for stakeholders impacted by change initiatives to the application or system processes for specific capabilities. Liaise with user forums or working groups

Partners with the R&D Learning on development of training materials

Delivers training to trainers and super-users (train-the-trainer)

Supports user acceptance testing of system enhancements and upgrades, providing SME advice on testing approach, script writing, review and approval.

Lead testing and support validation efforts for business capabilities, including participating in Operational Qualification and Performance Qualification of systems.

Defining a suitable test strategy and test cases to support release management of systems/technologies within a specific clinical trial business capability.

Participate in system/technology work streams and outcomes in change initiatives.

Contributes to internal/external continuous improvement initiatives.

Additional Skills:

Experience and Requirements section

Experience in clinical trial, data, or technology management

Knowledge of Clinical Trial Business Capabilities such as eTMF, eConsent, EDC, Clinical Trial Portals, Patient Portals, HCP Portals, eCOA, Clinical Trial Data Warehouse and Clinical Trial Monitoring.

Knowledge of GCP/ICH guidelines, regulations