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Clinical Project Management Responsible for coordinating and managing all aspects of clinical study activities to maintain regulatory compliance and meet company timelines and goals for the clinical development program.
Managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met.
Managing study-related vendors and serving as the primary point of contact for contracted CROs, study staff and contract labs; identifying potential risks and resolving issues with CROs; establishing vendor management plans and reviewing quality metrics.
Providing input into and/or developing study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study drug order forms.
SAS Statistical Programmer Responsible for performing all SAS programming tasks required for clinical trial analysis and reporting. This position works closely with other members of the Biostatistics, and Data Management departments on various clinical projects.
Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.
Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.
Clinical Data Management Responsible for ensuring high quality data is obtained, processed and reported to Sponsors and defines the methods and tools ERT uses to provide these services. The Data Manager is the primary contact for all data-related issues for both internal and external teams.
Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including Data collection, Data delivery and reconcilliation, Data lock and Data Management activity timelines.
Determine standard edit checks necessary to ensure clean data and define new edit checks when standard checks are insufficient.
Provide or customize ERT standard file specifications, review and/or consult with Sponsor on Sponsor-defined specifications, and coordinate finalization and approval of file specifications between Sponsors and SAS Programmers.
Clinical SAS Programmer Responsible for building programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study's protocol or statistical plans.
Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.
Write SAS programs to generate tables, listings, and figures and analysis datasets.
Work in tandem with Biostatistics and Data Management member on various clinical projects.
EDC Developers Responsible for understand and ensuring compliance with IT guidelines for system development, implementation, and system security. Excellent understanding of integration between interfaces both inbound and outbound.
Technical Background in SQL Server, PL/SQL, ODM, Web services, Java
Business knowledge of Clinical Data Management.
Experience in application operations and support including knowledge and experience of Incident, Problem, and Change Management.
Knowledge of Consumer Healthcare and ITIL Support Processes.
Biostatistician Responsible for bringing statistical expertise to the design, conduct, analysis and reporting of clinical studies, in the pre-clinical, Phases I to IV, and post-marketing, stages of study. Applies statistical theory and methods to the design and analysis of clinical trial data.
Prepares data analysis plans, assists with the preparation of manuscripts and writes reports describing results of statistical analysis.
Consults with medical directors, clinical safety monitors, clinical safety reviewers, and clinical trial managers on statistical questions.
Represents the Biometrics, Data Management & Programming (BDM&P) group in regulatory agency and project team meetings.
Clinical Research Associates Responsible for collecting and organizing data obtained during studies and trials conducted in fields, such as biotechnology and pharmaceuticals. Manage and process results gained from long-term testing of drugs, products and medical procedures.
Coordinate the collection, distribution and storage of data obtained during clinical research trials, such as those which test drugs and medical products.
Ensure that trials stay on track with clinical objectives and comply with federal regulations, including analyzing data, creating reports, making presentations, and monitoring individual cases of testing participants. Explain procedures to participants and family members and use reference material to conduct additional research.
Maintain databases of patient information, draft correspondence and gather data used in grant proposals and budgeting.
Clinical Trial Managers Responsible for the operational management and oversight of clinical trials within a clinical development program. Works closely with the Medical Monitors and other cross-functional representatives, including Clinical Data Management, Biostatistics, Regulatory and Quality Assurance.
Perform clinical data review of data listings and summary tables, including query generation.
Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
Develop and maintain good working relationships with investigators and study staff.
Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures.
Clinical Scientist Responsible for providing scientific support for clinical research and product development initiatives under the direction of GCDL/GDTL. Provides clinical scientist input into all regulatory questions, runs ad hoc searches.
Preparation of targeted reviews and profile of outliers, search and summarize information relevant for various clinical documents preparation.
Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents and reports.
Support GDTL/GCDL to provide scientific leadership in execution of clinical trials. Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, and pharmacovigilance.
Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles.
Quality Assurance Responsible for Process Improvement, Analyzing Information , Strategic Planning, Verbal Communication, Informing Others, Quality Engineering, Emphasizing Excellence, Pharmacology, Attention to Detail, Thoroughness, and Dealing with Complexity.
Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
Medical Writer Responsible for providing technical specifications from medical workers and arranging that information as part of a compliance package for biomedical and pharmaceutical firms. Regulatory guidelines come from the Food and Drug Administration (FDA).
Coordinate with various technical professionals to gather, organize and compile information on new products or processes.
Prepare and compile the paperwork necessary to submit new drugs and therapies for review by the FDA and other organizations.
Regulations can vary significantly. FDA guidelines state, according to section 312.23 of the Code of Federal Regulations, that Investigational New Drugs (IND) require the submission of a document that includes sections on the protocol for each planned study.
Drug Safety Responsible for managing activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products.
Ensures timely submission of reports regulatory agencies in accordance with applicable regulations and that all inquiries from the FDA and other drug regulatory agencies are responded to in a timely manner.
Respond to inquiries from health care professionals, consumers, and company personnel regarding safety issues with marketed products; prepare periodic comprehensive written reviews of all assigned AEs.
Identify potential sources of product litigation, extract AE data from various clinical trial cases and spontaneous sources; manage case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries; and ensure proper coding (MedDRA) into the global AE database.