Evolution Research Group

Software Engineer

• Develop, program, validate and maintain EDC clinical trial databases in accordance with study protocols and/or source documentation.
• Lead post-production discussions and assist with closing functional gaps and required remediation.
• Generate and maintain all required documentation related to programming activities; ensure quality of the programming and adherence to company standards.
• Identify and recommend how to optimize CRO processes based on tool functionality.
• Assist with management of external application vendor responsibilities, integrations, and implementations.
• Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs.
• Actively participate in database-related user groups, to include standard forms workgroups and process improvement workgroups.
• Assists the Biostats and Data Management teams in the development and delivery of a variety of complex data processing, reports, and dashboards.
• Provides technical guidance and leadership to less-experienced individuals regarding IT functions, EDC programming, etc.
• Communicates with cross functional groups throughout the project lifecycle.
• Monitors project scope.
• Maintain a strong understanding of departmental and company procedures.
• Maintains key vendor relationships such as EDC system vendors, etc.
• Contribute to maintenance of EDC template database.
• Identify processes that will increase productivity, quality and efficiency.
• Performs other miscellaneous related duties, as required.

CRO – Electronic Data Capture (EDC) Developer, Contract Role

Project Manager

• Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities.
• Manage and execute the overall project scope, budget, and timelines.
• Identify project success factors for analysis, reporting, and tracking.
• Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements.
• Lead the development of study specific protocols, consent forms, and other trial related materials as required.
• Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
• Participate in the review of clinical data for analysis.
• Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
• Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
• Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device.
• Monitor adherence to project contract and budget.
• Coordinate with clinical, marketing, and operations management to identify goals and scope of clinical study projects.
• Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed.
• Support the management and oversight of clinical study related vendors.
• Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements.
• Provide therapeutic training and guidance to clinical team.
• Enhance department and organization reputation by participating in departmental or corporate initiatives.
• Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Attending off-site meetings and conferences, as needed.
• Perform other miscellaneous related duties, as required.

Education and/or Experience: Bachelor’s degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.
CRO experience is highly desirable.
Experience qualifying & managing external vendors.
Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
Experience writing, reviewing, and editing protocols and clinical study reports as well as working knowledge of the FDA submission process.
Skills and Abilities: Ability to facilitate a teamwork philosophy with a positive attitude.
Extensive organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives.
Extensive experience overseeing and coordinating the work of others.
Ability to work effectively and efficiently handling multiple tasks simultaneously.
Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
Ability to manage multiple deadlines.
Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
Strong computer skills, including Microsoft Office.

CRO – Electronic Data Capture (EDC) Developer, Contract Role

CRO-Project Manager