Description:

　　• Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures

　　• Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies

　　• Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules

　　• Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming

　　• Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation

　　• Troubleshoot technical issues as appropriate

　　• Design “smart” listings and study-specific processes for effective data review, query issue and resolution

　　• Manage queries and trends to ensure data completeness and integrity

　　• Perform coding of adverse events, medical conditions and medications.

　　• Perform SAE reconciliation

　　• Lead and perform pre-lock and data lock tasks

　　• Prepare training materials and user guides for EDC data collection tools, deliver user training

　　• Participate in client and team meetings as required, providing status updates and advising on best practices as appropriate

　　• Design, generate, and review status metric reports, identifying and communication trends as needed

　　• Ensure archiving of study databases and related documents

　　• Organize and file study documentation

　　• Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies

　　• Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes

　　• Provide study specific training for team members and end users, as appropriate

　　• Implement technical solutions, new tools, and resolve complex issues

　　• Lead large and complex projects

　　• Lead client and team meetings as required

　　• Delegate tasks as appropriate, providing mentorship and following through completion

　　• Interact with sponsors and manage vendors for complex studies

　　• Assist with identification of project scope changes

　　• Present at sales and marketing meetings for prospective clients

　　• Develop SOPs and manuals

　　Day to day:

　　this person will be responsible for the day-to-day data management doing the hands-on data for their clients specifically within oncology and rare disease studies . will be working on large complex studies working within Medidata Rave and Inform/Medrio. Working with their sponsor companies to develop SOPs and completing these SOPSTop Skills Details:

　　Data management,Edc,medidata rave,inform,medrio,Vendor management,Clinical research,Rave

　　Additional Skills & Qualifications:

　　True Must haves:

　　• Minimum 9 years of experience in Clinical Data Management

　　EDC systems, such as Medidata Rave, InForm, Medrio

　　sponsor and vendor experience

　　Hands on data experience vs oversight experience

　　SKILLS

　　• Knowledge of medical terminology and pharmaceutical notation

　　• Expertise with EDC systems, such as Medidata Rave, InForm, Medrio

　　• Excellent organizational and time management skills

　　• Strong collaboration and leadership skills

　　• CRO experience

　　• Oncology and rare disease required

　　• EDC experience: Medidata rave experience, Medrio, inform

　　• Sponsor and vendor experience

　　• Large/extensive study experience

　　About Actalent

　　Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

　　If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.