(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Lake County, IL is looking for a Clinical Data Coordinator - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Experienced data management professional who is responsible for all activities relating to over 20 studies over the course of 1 year. The primary goals are to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams. Also includes Case Report Forms; initiating the purchase of CRFs, diaries, and related documents from clinical protocols, preparing the study database dictionary; developing quality assurance database checks. BS Preferred. Perform data management tasks on clinical studies as work experience increases. This may include, but is not limited to CRF design, database dictionary design, quality plan creation and study documentation activities. Candidate should have the following Oracle Clinical database experience: data entry, Discrepancy Management, DCF creation and printing, and report creation using SQL. You MUST meet all of the above qualifications in order to be considered for this position.
(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Lake County, IL is looking for a Clinical Medical Services Specialist - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests. Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary. Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications. BS Preferred. BSN Highly Desired: Members of the department answer Health Care Professionals' questions regarding adverse events in the Postmarketing database. Consumer questions are addressed regarding package insert related product information. Postmarking Safety is also involved in the ongoing review of reported events as they relate to a drug safety profile, and in responding to ad hoc government agency requests. Good communication/ good computer skills necessary. Microsoft programs and Lotus Notes exp preferred. You MUST meet all of the above qualifications in order to be considered for this position.
(US-Pennsylvania) Our client is looking for a Data Manager with the following requirements. POSITION SUMMARY: The data manager will be part of a cross-functional team working on a variety of indications with current emphasis on CRF development and support of study start-up, and longer-term emphasis in the general management of databases for each of the clinical trials. PRINCIPAL RESPONSIBILITIES: The data manager will be responsible for developing case report forms (CRFs) and assorted but related documents, e.g., CRF completion manuals and data entry guidelines. Responsible for reviewing and understanding clinical-trial protocols. Work with Contract Research Organizations (CROs) to ensure correct database set-up and timely delivery of databases and other clinical trial results. Must be able to perform basic reporting of data via SAS, (e.g., produce summary tables and descriptive statistics), with input from statisticians when needed. Review and have input in the development of analysis plans, working closely with colleagues, in order to relay clarifications to CROs. Give input and advise in the development of company processes and infrastructure for data management. ORGANIZATIONAL RELATIONSHIPS: The position reports to the Manager of Biostatistics and Data Management. It supports all of Clinical Development, working most directly with the Manager of Biostatistics and Data Management and interfacing with the Director of Clinical Development and the Manager of Clinical Operations. SCOPE- NUMERICAL INDICATIONS OF THE SIZE OF THE JOB: 35%:CRO interaction and management 30%:CRF Development and support of ongoing clinical trials 10%:Quality assurance 10%Analysis and reporting 10%:Development of internal business processes 5% Other, Administrative TRAINING AND EXPERIENCE REQUIRED: Data management or statistical related degree (B.S. or M.S.). Three to five years working in clinical trials, depending upon experience (Phase II studies or higher preferred). Two to four years experience in Case Report Form development, data entry, tracking or general clinical trial study management. At least one year experience in protocol review during protocol development. At least 1 year of concurrent experience with SAS Base and SAS Stat. At least 2 years experience with MS Office, especially Word and Excel. Familiarity with Analysis Plans (actual experience in the regular review of Analysis Plans is preferred; actual experience in writing plans is a plus). Good communication skills, especially in developing instructions or training materials are important as well as good organization skills and staying focused. Familiarity with the process of User Acceptance Testing is helpful but not required. Additional software experience highly desirable: SAS ODS SAS macros SAS Graph (version 6 or higher) Editing of PDF files via Adobe Acrobat Experience in autoimmune diseases (e.g., Crohn's Disease or Rheumatoid Arthritis) is helpful but not required.
(China) Senior Research Positions Medgenn Inc., Yantai, Shandong, China Yantai Medgenn is one of the leading biotech companies in China. With one drug already in clinical trial phase III, the company is more than ever committed to promote excellence in drug research and development. In the midst of a significant expansion of the R&D group, we invite outstanding scientists to apply for multiple senior research positions. Though not limited to, we are particularly interested in people with experience in one or more of the following fields: 1) protein expression in eukaryotic cells; 2) pharmaceutics; 3) protein or chemical drug design. Applicants with industrial experiences and with experiences either on animal models for drug screening or clinical trial designing are strongly encouraged to apply. Medgenn offers competitive salaries, good stock incentive plan, subsidized housing and other compensation benefits. More importantly, Medgenn creates a nice working environment for colleagues to work together efficiently to achieve our common goal.
