Clinical Data Manager Jobs

Job Title: Sr. Clinical Data Manager- i3 Statprobe- Any i3 Office Location Company: UnitedHealth Group Location: Indianapolis, IN Description: UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans. Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health. i3 Statprobe provides a full range of data management and biostatistical services for the pharmaceutical and biotechnology industries. We not only pay relentless attention to the details, we also lend a broader perspective to a client's data management needs. We realize that strategy is just as important as process, and we provide a higher level of thinking for data management and biostatistics. As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.   We currently have a need for a Senior Clinical Data Manager. This position can be located in any one of our i3 Statprobe locations.   This position requires strong data management knowledge and skills. Senior Clinical Data Managers lead data management activities for projects involving multiple and/or complex clinical studies including global studies. They are able to work without close supervision and can coordinate the activities of other junior staff members. Assumes overall responsibility for the successful execution of the projects assigned to them.Reviews and approves all required study documentation. Performs any data management activities related to projects, as needed. May act as Team Leader for data management projects. Provides leadership and supervises Data Management staff assigned to work on their projects, including Clinical Data Coordinators and Clinical Data Associates. Monitors the progress of all data management activities for the project to ensure that project timelines are met. Monitors the quality of all data management activities for the project. Monitors the data management process for the project to ensure that work is proceeding in an efficient manner. Serves as Data Management contact with Sponsor managing client expectations, noting and responding to out-of-scope work. Some business development work may be required, such as input to proposals and client presentations.Some line management activities may be required. Work effectively with international peers and sponsors, as needed. Job Requirements: Qualifications: B.A./B.S. Degree in related field, or an equivalent combination of education and work experience. Minimum of 5 years of clinical data management experience. Previous team leadership experience or strong leadership skills. Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH, GCP. Demonstrated proficiency in the data management process. Excellent interpersonal and communication skills (written and verbal) Strong attention to detail Proficient in the use of the clinical data management systems used at Ingenix Pharmaceutical Services. Possesses a positive attitude and works well with others. Diversity creates a healthier atmosphere: an equal opportunity employer, M/F/D/V.   UnitedHealth Group is a drug-free workplace.  Candidates are required to pass a drug test before beginning employment.

Job Title: Clinical Data Manager - Experience with Oracle Clinical (SQL, SAS) Company: Synerfac Technical Staffing Location: Somerset, NJ Description: Job Title: Clinical Data Manager (5-7+ years of experience) Location: Somerset, NJ Duration: 6-months to PERMANENT POSITION    Salary Range: $24.00 - $26.00 per hour Work for a growing Central New Jersey area company involved in clinical trials for drugs, biologics, and medical devices. Clinical Data Manager: Summary: Involved in the cleansing and clarification process of clinical trials. Duties:Successful candidate will perform quality reviews using Oracle Clinical.  Review and approve Data Management Plans.  Write queriesReview data and advice on any adverse effects/discrepancies Experience/Requirements:  5 years in Clinical Data Management; Experience with Oracle Clinical (SQL, SAS), Medical Coding, multi-tasking, problem-solving and effective verbal/written skills. Bachelor Degree in Computer Science, Life Sciences or related field preferred, or equivalent experience. Experience with a comparable position within the pharmaceutical, biotech or CRO industry. Please e-mail all resumes to:  Register to View for consideration. Contact Information: Kevin StinesAssistant Branch ManagerSynerfac Technical StaffingPhone: Register to View Fax: Register to View E-mail: Register to View

Job Title: Direct Hire Position! Clinical Data Manager Needed for CRO in S Company: Kelly Scientific Resources Location: Southborough, MA Description: Kelly Clinical Research has a Direct Hire Opportunity for a Clinical Data Manager with a leading international CRO with proven expertise in supporting global clinical trials for pharmaceutical, biotechnology and medical device companies located in Southborough, MA. Under general supervision, the Clinical Data Manager reviews data; assists in database design and testing; designs CRFs and guidelines; designs and tests logic checks; generates queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; works with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues; provides input into the department SOP's and process improvements, and may participate in working groups, and the training of other CDM's. Responsibilities include: Review and understand protocol. Relate CRF design to protocol and ensure consistency. Identify and suggest design for standard data types. Create effective / efficient CRF design for standard data types. Create CRF completion guidelines. Present CRF and CRF completion guidelines at investigator meetings. Review and contribute to database design specifications and assure all data fields are captured and validation checks are complete. Assist in database design and build activities. Test database prior to release into production. Development and maintenance of the Data Management Plan (DMP), the Data Cleaning specifications and various other Data Management documentation. Ensure accurate tracking of all CRFs and DCFs and identify any missing information. Prepare CRF for data entry, apply data handling guidelines. Notify data entry supervisor of entry and tracking priorities. Monitor Clinical Data Management project status through use of standardized status reports and customized metrics. Assist Sr. CDM with external data providers import/ exports of data. Develop, define, test and validate logic checks. Apply standard logic checks to routine data cleaning. Review logic check output, CRFs, and listings to identify missing or discrepant data. Generate DCFs based on standard data cleaning practices. Write clear and concise queries. Utilize available tools, systems and processes in coding medical terms and medications. Reconcile clinical AEs with SAEs according to established guidelines. Understand the fundamentals in managing lab data, including normal ranges and units from local and central labs. Understand the fundamentals of merging external data with the clinical CRF data. Coordinate data entry audits. Creation of Audit Results Report. Ensure that all steps prior to locking the database are complete, utilizing a CDM checklist. Review and identify inconsistencies within the final data tables, listings, and report. Assisting with Data Management Initiatives. Under the direction and guidance of Senior Management, CDM may also assist with the following: o Suggest and/or challenge unnecessary data collection and identify gaps in detail content. o CRF design for complex data types. o Identify data that will require non-standard programming. Identify errors in design and recommend what corrective action is necessary. o Create new tools for tracking and inventory, including reports to identify discrepancies. o Identify inefficiencies in entry flow and recommend solutions or improvements. o Identify complex checks that are non-standard and contribute to logic check definition with understanding of analysis plan content. o Develop database specifications to facilitate the collecting, processing and reporting for lab data. o Represent department at industry and client meetings. Perform all other duties as assigned. Requirements: Bachelor's degree and 1 year of clinical data management experience in a role with equivalence to CDM/CDC. Experience in a CRO/pharmaceutical/biotech environment is preferred. Must have a basic understanding of the clinical research development process and database design; a good understanding of the clinical data management process, physiology, pharmacology, and clinical study objectives and methodologies. Must have good problem-solving skills and be detail-oriented. Excellent organizational skills with ability to work in a high volume and strict deadline environment. Proficiency in operating computer applications and navigating the internet. Excellent interpersonal skills. Excellent verbal and written communications skills. Ability to work independently. Proficiency in MS Office (MS Word, Excel, and Power Point). If you would like a new position for the New Year, then please Apply Now and submit your resume for review! Job Requirements Please refer to the job description above.

Job Title: Clinical Coordinator - Venture School Company: Rushford Center Location: Meriden, CT Description: Responsible for maintaining a high quality of clinical services offered by the School. Completes Functional Behavioral Assessments and Behavioral Intervention Plans. Works closely with principals, teachers and clinicians to provide behavior management and Program consistency. Facilitates communication among all members of a child's support constellation.   Requirements Education • Master of Science Arts/Science • Must be certified as a teacher, social worker or school psychologist Experience • Minimum of five years' related experience • Basic working of knowledge of personal computers including electronic mail and scheduling

Job Title: Assistant Clinical Data Manager/Data Team Lead- Overland Park, KS Company: Quintiles Transnational Corp. Location: Overland Park, KS Description: The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiastic Assistant Clinical Data Manager/Data Team Lead to join our team! Purpose: Provide comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs. Provide leadership role as a Data Team Lead (DTL) or in a leadership role in a specific DM task (e.g. lead of a task on a megatrial, coder, database designer for technologies that don’t require extensive programming expertise). Responsibilities: Serve as Data Team Lead (DTL) on multiple global studies.Provide leadership to DM team.Manage DM customer relationship for DM project team including active participation in DM customer negotiation ontimeline, budgetary and other issues (with guidance).Provide marketing capabilities presentations and business development presentations.Serve as Data Team Lead for one or two global studies with fewer than 20 operations staff(excludes DE), or serve in a leadership role to a specific DM Task.With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadershipand technical expertise to Operations team.Manage delivery of projects through full data management process life-cycle.With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justifyout-of-scope.Provide input for negotiations with customer.Provide comprehensive data management expertise (including all operations tasks and DMP generation).Perform database designer activities for technologies not requiring extensive programming.Perform comprehensive quality control procedures.Independently bring project solutions to the CDM team.Solves issues through using the global issue escalation/communication plan.Consult with Standards Group for process issues; communicate ideas for process improvement.Assist in developing and implementing new technology.Understand and comply with core operating procedures and working instructions.Meet objectives as assigned.Develop and maintain good communications and working relationships with CDM team.Interact with CDM team members to negotiate timelines and responsibilities. Bachelor’s degree in clinical, biological or mathematical sciences, nursing degree or related field, with a minimum of 3 years experience in a clinical data management role, specifically in a CRO, pharmaceutical or biotech environment or the equivalent of education, training or experience.Candidates must have prior work experience in a lead role, managing assigned projects on all levels, acting as the lead. Candiate must have a thorough knowledge of the clinical trial data management process.Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology.Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III).Comprehensive understanding of clinical drug development process.Excellent organizational, communication, and data management skills (detail oriented).Ability to establish and maintain effective working relationships with coworkers, managers and clients. PLEASE APPLY USING THIS BUTTON ONLY

Job Title: Clinical Data Manager Company: MedFocus Location: Southborough, MA Description: CLINICAL DATA MANAGER COMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.   Our client is a leading international clinical research organization with proven expertise in supporting global clinical trials for pharmaceutical, biotechnology and medical device companies and is seeking to add a Clinical Data Manager to their team in Southborough, Massachusetts.   RESPONSIBILITIES: Under direct supervision, the Clinical Data Manager reviews data; assists in database design and testing; designs CRFs and guidelines; designs and tests logic checks; generate queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; works with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues. Job Requirements - Must have a basic understanding of the clinical research development process and database design; - A good understanding of the clinical data management process, physiology, pharmacology, and clinical study objectives and methodologies; - Good computer skills; - Good verbal and written communications skills; - Good problem-solving skills; - must be detail-oriented. - 2+ years of clinical data management experience; experience in a CRO/pharmaceutical/biotech environment. - Oracle Clinical or ClinTrials experience a plus.    EDUCATION: - Bachelor's degree or equivalent combination of education and experience.    MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

Job Title: Sr. Clinical Data Manager Company: CSG, Inc Location: Rye Brook, NY Description: ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING: • Review and understand protocol with reasonable comprehension. • Suggest and/or challenge unnecessary data collection and identify gaps in detail content. • Relate CRF design to protocol and ensure consistency. Identify and suggest design for standard data types. • Create effective/efficient CRF design for standard and complex data types. • Create CRF completion guidelines. • Organize and present CRF and CRF completion guidelines at investigator meetings. • Review and contribute to database design specifications and assure all data fields are captured and validation checks are complete. Assist in database design and build activities. Identify data that will require non-standard programming for database design. Identify errors in design and recommend what corrective action is necessary. Test database prior to release into production. • Development and maintenance of the Data Management Plan (DMP), the Data Cleaning specifications and various other Data Management documentation. • Ensure accurate tracking of all CRFs and DCFs and identify any missing information. • Prepare CRF for data entry, apply data handling guidelines. Notify data entry supervisor of entry and tracking priorities. • Identify inefficiencies in entry flow and work with management to recommend solutions or improvements. • Monitor Clinical Data Management project status through use of standardized status reports and customized metrics. • Work with external data providers on import/ exports of data. • Develop, define, test and validate logic checks. Apply standard logic checks to routine data cleaning. With understanding of analysis plan content, identify complex checks that are non-standard and contribute to logic check definition. • Review logic check output, CRFs, and listings to identify missing or discrepant data. Generate DCFs based on standard data cleaning practices. Write clear and concise queries. • Evaluate and improve efficiency in data cleaning process by identifying tools and processes that will make CRF review more efficient. • Define project standards for written queries and the DCF process. • Create new tools for tracking and inventory, including reports to identify discrepancies. • Utilize available tools, systems and processes in coding medical terms and medications. Review and provide feedback on coded terms. Understand coding algorithms and assure correct algorithms and coding systems are utilized. • Reconcile clinical AEs with SAEs according to established guidelines. • Provide expertise in managing lab data, including normal ranges and units from local and central labs. Develop database specifications to facilitate the collecting, processing and reporting for lab data. • Provide expertise in merging external data with the clinical CRF data. Develop database specifications, collecting, processing and reporting for external data. • Coordinate data entry audits. Creation of Audit Results Report. • Ensure that all steps prior to locking the database are complete, utilizing a CDM checklist. • Review and identify inconsistencies within the analysis plan, the final data tables, listings, and report, including review of SAE narratives. • Provide input for changes to Standard Operating Procedures and process improvements where appropriate. • Provide input into new technologies to aid in clinical data management. • Coordinate or guide CDC and CDM tasks on large projects. • Assisting with Data Management Initiatives. • Represent department at industry and client meetings. • Perform all other duties as assigned.   Job Requirements EDUCATION AND/OR EXPERIENCE: • Bachelor’s degree and minimum 3 years experience in clinical data management as a CDM including some experience in a CRO/pharmaceutical/biotech environment and experience leading a team or 5 years clinical data management experience as a CDM. • Preferred Qualifications: Advanced degree and 3+ years experience in clinical data management; experience leading a team; experience training or mentoring staff, and 1+ years of CRO experience.

Job Title: Clinical Data Manager III- Ref 3178 Company: Atlantic Search Group, Inc. (ASG) Location: Paramus, NJ Description: ASG, Inc. is a global outsourcing and specialty staffing organization that works with companies involved with clinical trials.  One of our clients in Paramus, NJ has an immediate need for a Clinical Data Manager.  This is a contract position.   Responsible for managing data management activities, liaising with CRO’s and interfacing with Clinical Operations on behalf of the Data Management Department to ensure that standards are communicated properly, that timelines are met according to objectives and goals and that data reporting needs are scheduled and addressed and that the quality of data management deliverables are monitored.   • Review CRF design. • Create CRF Completion Guidelines/Mock CRF’s and coordinate their review and approval • Review and approve Data Management Plan components, i.e., study summary/data flow diagrams, timelines, critical variables list, etc. • Review Data Validation Specifications and coordinate input for client’s Biometrics/Data Management Departments to ensure that Statistical Analysis Plan (SAP) requirements will be met • Specify data review tools to be included in CRO’s data validation process to ensure that safety and SAP requirements are met • Represent department on clinical trial team, project management and status reporting • Handle AE/SAE reconciliation • Monitor external batch data loading and any CRF to electronic data inventory reconciliation • Ensure that CRO’s are meeting client’s timelines for data deliverables by requesting/reviewing metric reports, keeping internal clinical teams informed regarding project status and issues as they arise and working closely with CRO’s to develop effective solutions to operational data management problems to bring them to resolution • Evaluate ongoing quality of CRO provided data management services by sampling OC discrepancies and reviewing DCF generation, tracking and processing, reviewing OC/SAS data monitoring tools, participating in OC database closeout planning/tracking and managing medical coding progress • Contribute actively to the review of working practices and the development of SOP’s. Requirements • Bachelor’s Degree in Life Sciences, Pharmacy or Nursing with 5 or more years of experience in drug development and the discipline of data management or an equivalent combination of training and experience. • Experience in Oracle Clinical data management system and familiarity with SAS required • Experience managing a CRO or working in a CRO environment required

Job Title: Lead Clinical Data Manager Company: Location: Durham, NC Description: StatWorks, Inc is a high quality specialty provider of biostatistical analysis and consulting, clinical data management, and report writing services focused exclusively on clinical trials and drug development. We are looking to grow our team of talented and experienced professionals by seeking a Lead Clinical Data Manager. Responsibilities:  • Reviews reports, listings, and other documents generated in data management for distribution to sponsor, investigators and their study support staff, or project files for accuracy and completeness • Maintains a professional working relationship with sponsor, collaborating associate, vendor, and subcontract personnel • Coordinates, prepares, and provides training of all key data management related study documents including CRF completion Instructions, Data Management Guidelines (DMG), CRF Annotation, Data Entry Guidelines • Responsible for reviewing validation, coding, query output, and developing edit check specifications based on approved DMGs • Coordinates data entry screen testing, edit check programming and testing • Serves as the primary project contact for data management with clinical, and sponsor • Monitors study costs, including estimating time, cost and resources required for a project • Performs staffing assignments for assigned projects, ensuring that the project is sufficiently staffed with qualified personnel and specific project requirements are met • Provides functional management and supervision of specific projects and project personnel, as well as conduct timely and thorough evaluation of work performance of all direct report personnel  • Provides in house instruction as part of technical career development for Clinical Data Associates including assisting in training progress assessment Requirements Education Required: Requires a minimum of a B.S./B.A. degree plus a minimum of 3 years directly related data management experience, or AA/AS and 5 years of health care or clinical research experience with 3 years directly related data management and related systems experience, or equivalent combination of education and experience that provide the skills and knowledge necessary to perform the job

Job Title: Clinical Data Manager III Company: Comrise Technology, Inc. Location: SOMERVILLE, NJ Description: ResponsibilitiesDirect and supervise all aspects of the data management process, ensuring compliance with FDA regulations related to data management. Provide guidance to Clinical Database Administrator. Train data entry personnel and Clinical Research Associates (CRA) in procedures relative to data management. Ensure compliance with department procedures. Provide input into Case Report Forms (CRF) design and approve CRFs for production use. Oversee the design of Oracle Clinical databases, including maintenance of the global library; validate database design; program edit-check procedures and validate new edit-check processes; perform and direct data entry processes; run batch validation and track DCFs through data cleaning; code adverse events and concomitant medications using standard coding dictionaries (MedDRA, WHO Drug); maintain coding dictionaries; lock/freeze databases; extract into SAS datasets for analysis. Administer Oracle Thesaurus Management System repository. Set up new studies in the Clinical Research Management System (CRMS) clinical trial management system, and maintain the CRMS database. Train new CRAs in the use of CRMS. 8 years of experience. QualificationsBS degree in Biological Science 4+ years of Job experience in Clinical Data Management or related field Experience in data management support of ICH, ISO, FDA regulatory studies Experience with medical principles and terminology is preferred Database Programming skills are strongly desired