Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.Job DescriptionJob Description: The position is responsible for supporting clinical data management (CDM) operational activities in one or more therapeutic areas. Primary responsibility is to support the development of clinical databases and the supporting documentation. Conducts requested data management activities related to assigned projects such as: specification development, database set-up activities, validation steps, quality assurance & data extracts procedures working in accordance with all applicable local procedures and associated regulatory requirements. Roles and Responsibilities:Preparation and review of documentation to support studies through their development life cycle (i.e. user requirement specifications, test scripts and change control documents). Documenting tasks on a timely and accurate basis including delineation of tasks and estimation of effort. Provide detailed project status updates to support project scheduling and workload management. Interact with Clinical Research and other team members to define and clarify project requirements. Ability to investigate and resolve simple operational issues and escalate complex operational issues to the appropriate resource for resolution. Participation in the development and maintenance of associated operating procedures. Liaise with the department and Information Technology as required for the support and maintenance of software packages associated with the collection of clinical data. Support the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables. Contribute to the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines. Employ standardized electronic and ad hoc reporting tools to review clinical data for consistency with the protocol requirements and good clinical practices. Partner with Clinical Operations personnel to manage the query lifecycle. Represent CDM in study team meetings and facilitate cross-functional activities (e.g. Clinical Data Listing Reviews). Accountable for the delivery of fit-for-use and regulatory-compliant clinical study data. Partner with External Service Providers (e.g. CROs, EDC Vendors, Central Labs) in order to support business goals and further the mission of CDM. SKILLS: Excellent written and oral communication skills. Knowledge of Microsoft Office applications. Excellent interpersonal skills, great understanding of team-culture. Demonstrate a nature of proactively, enthusiasm, independent drive, and energetic outlook to tasks. Exceptional organizational skills, Works towards and meets deadlines. Ability to collaborate, build strong partnerships/relationships with all stakeholders. The candidate must be willing to take on additional projects and work overtime. ADDITIONAL KNOWLEDGE: Applicable Standard Operating Procedures, Good Clinical Practices (GxP Regulations; ICH Guidelines; Good Quality Practices) 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials). Good Clinical Data Management Practices, HIPAA, Drug Development and Approval Process.EXPERIENCE/EDUCATION: 2 years of industry experience in data-management, additional industry experience or equivalent experience in the Pharmaceutical, Device or Biotech industries (Sponsor, CRO or combination) in roles of increasing responsibility. Work requires knowledge of basic mathematical, data collection, medical terminology, and research principles generally acquired through two years of post-secondary education. A college degree is required; Bachelor’s level is preferred but not required.Additional InformationAll your information will be kept confidential according to EEO guidelines.