Description:
Responsible for the global planning, , and coordination of data management activities in a project; ensures overall database consistency across all studies within a project; manages all activities centered around CRF design, data collection, data retrieval, global integrated database development, coding, and query management for PoC to Phase 4 clinical trials; oversees, monitors, and evaluates all interactions with external vendors (CROs); and ensures data management standards and quality are maintained and implemented.Duties and Responsibilities:Oversees all project related Data Management activities at Daiichi-Sankyo, including but not limited to, CRF design, data collection, edit checks, consistency of data collected across investigative sites, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits of the database against data collection instrument sources, database locks, and archival of Data Management deliverables and documents.Primary contact for all project teams, domestic and global, to ensure data quality and timely database delivery.Reviews Data Management performance against established metrics in a Data Management Performance Report, prepared at the conclusion of each study.Ensures that a archive of Data Management documents and records is maintained at the Daiichi-Sankyo site in accordance with applicable Daiichi-Sankyo and regulatory guidelines.Evaluates contracted regional CROs on an ongoing basis to determine if they fulfill requirements of SOPs (including Working Policies (WPs)), timeliness, and quality.Evaluates candidate CROs and external vendors as to their ability to adhere to Daiichi-Sankyo SOPs (including WPs), and quality standards before any outsourcing contract is finalized.Manages database and supporting documentation archival to meet long-term regulatory requirements.Demonstrates Daiichi-Sankyo core at the management level; exhibits Daiichi-Sankyo valuesEnsures that all project related outsourcing agreements are and .Qualifications:MS; BS/RN in life sciences 4 to 6 years (MS) pharmaceutical/data management 6 to 8 years (BS/RN) pharmaceutical/data management Project management experience preferredGood oral and written skills. Proficient in Microsoft Office Suite including Word, Excel, and Project. Good problem solving, analytical, , and time management skills. Must demonstrate initiative, flexibility, and be able to work well in a team environment. Demonstrated knowledge of clinical data flow and research design. Clinical database administration and system validation experience. Demonstrated with GCP/regional regulatory guidelines, SOPs (including WPs), medical terminology, standard coding dictionaries, and demonstrated proficiency in applying them to all relevant therapeutic areas. CRO management experience, including a thorough knowledge of CRO audits.
Job Title: CLINICAL DATA MANAGER II
Company: MedFocus Pharm. Res.Opp.
Location: Florham Park, NJ
Description:
CLINICAL DATA MANAGER II
COMPANY INFO:
NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Clinical Data Manager II to work in Florham Park, New Jersey
Our client is a company that wants to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life.
RESPONSIBILITIES:
Develop and maintain trial specific database applications, including eCRFs, validations programming, monitoring reports and database specifications in support of in-house and outsourced trials globally for Phase I-IV clinical trials.
Working knowledge/experience in global clinical trial practices, procedures and methodologys.
Excellent verbal and written communication skills.
Excellent presentation, organizational, interpersonal and diplomacy skills.
Continuous improvement mentality and attention to details.
Intermediate knowledge of office tools.
QUALIFICATIONS:
BA/BS in computer science, Mathematics, statistics, life sciences or related fields.
3-5 years of experience in setup of clinical database and CRF design using Clintrial or equivalent clinical database management system, is desirable, preferably supporting clinical trials/or in the pharmaceutical industry.
KEYWORDS:
Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor
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.
PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!
Job Title: SQL DBA Manager
Company: Brooksource
Location: Chicago, IL
Description:
My client in the healthcare industry located in the O'Hare Area is seeking a SQL DBA Manager. This is a full-timeopportunity with competitive salary and benefits!Clientwill interview immediately! This position will provide 3rd tier support throughout the client life cycle and manage a team of Technical Consultants. Collaborate with the Client Solutions team to ensure timely resolution to escalated service requests. Interpret, evaluate, and resolve complex problems reported to the client Helpdesk regarding hardware, system software, and software applications. Technical troubleshooting and analysis related to the maintenance of the software Act as a liaison between the client and client's internal teams Utilize specific functional or technical areas of expertise to assist in the resolution of escalated service requests Identify software deficiencies and/or defects and propose software fixes for review by development team Participate in special ad-hoc department or company-wide task forces Manage and mentor staff of 10 Research and document processes that relate to escalations
Job Title: Clinical Data Manager II for i3 Statprobe (office-based position - Indianapolis, IN preferred)
Company: UnitedHealth Group, Inc
Location: Indianapolis, IN
Description:
i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. The company demonstrates leadership and innovation by leveraging world-class process design and six-sigma quality, affording clients the ability to maximize efficiencies and exceed customer expectations.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. Its a rare combination for success that only a career with i3 Statprobe can provide.i3 Statprobe currently has an immediate need for an office-basedClinical Data Manager II (Indianapolis, IN preferred).This position leads the clinical data management process for individual clinical trials. The Clinical Data Manager II possesses sufficient technical and organizational skills to work without detailed supervision. Clinical Data Manager II leads data management activities for multiple clinical trials, including global trials.Responsibilities:Acts as a key team member during the study start-up process by performing User Acceptance Testing (UAT) of the database, validation procedure testing and providing feedback to the clinical database programmers.Writes, updates and/or reviews Data Management Plans and other key study documents.Creates, reviews, and processes Data Clarification Forms and updates the databases.Manages the clinical data management process for multiple simple or complex trials.Performs other miscellaneous activities along with QC of database, processes and documentation, as required.Supports training of project staff (CDCs, CRAs etc) on project specific or data management processes.Performs reconciliation of SAEs.Performs reconciliation of laboratory or any external (third party) vendor data.Proposes alternatives and solutions for improvement in quality of work.Directs activities associated with data integration and data.Regularly liaises with monitoring, database programming, medical coding and statistical programming teams to ensure smooth functioning of a study.Liaises with clients and produces trial progress reports.Possess understanding of data management budgets and can communicate out of scope requests to data services project manager.
Job Title: Business Data Manager
Company: Newedge USA LLC
Location: Chicago, IL
Description:
FUNCTIONAL JOB TITLE: Business Data Manager
TASKS AND RESPONSIBILITIES:
The Business Data (BD) Manager is a member of Newedge USA's Operations Process Control team.
The BD Manager is responsible for all aspects of Newedge USA's Operations static data; including the definition, maintenance, and control of the procedures related to Accounts, Exchanges and Products data.
Manages teams, systems and processes to guarantee data accuracy and integrity.
Manages the department procedures and guarantees their accuracy and their observance.
Liaises globally with Sales, Operations and other support functions to identify and implement the standardization of data codifications.
Participates in the definition and implementation of a global strategic view for Business Data
Collaborates with the other BD Managers from Europe and Asia to optimize a "follow the sun" Business Data service.
In collaboration with the Process Control team, identifies, prioritizes and follows the deployment of IT solutions related to Business Data projects and tasks.
Participates in the definition, implementation and monitoring of Key Performance Indicators for the Business Data Department.
Depending on skills and experience, participates to the overflow of day-to-day operations tasks.
Establishes a cordial working relationship with business managers for the purpose of staying informed of business direction and the goals of management;
Stays informed on the business knowledge to better serve the Operations and Customer Services departments.
SUPERVISION DUTIES (if any):
Supervises the New Accounts and Static Data supervisors
Manages the team performance by establishing relevant objectives and work atmosphere to achieve excellence and efficiency.
SKILLS AND EXPERIENCE NEEDED:
5+ yrs experience with GMI, Sungard's Listed Derivatives Back-Office application
2-5 yrs experience in other Listed Derivatives and OTC, Middle and Back-Office applications (Clearvision, Phase 3, Kondor)
Experience in data analysis tools (Data queries, Excel Pivot)
Strong managerial and organizational skills
Strong written and verbal communication abilities.
Good understanding of financial markets, trading and clearing of derivatives (Futures & Options) and OTC products (Equities, Securities, Currencies).
Ability to analyze and document process and information flows
Bachelor's degree or equivalent industry experience
LEVEL OF AUTONOMY:
Responsible for staffing decisions made within Static Data. Participates in the definition and implementation of a global strategic view for Business Data
Job Title: Manager of Data Analytics
Company: Enterprise Associates, LLC
Location: Newton, MA
Description:
The Manager, Data Analytics is responsible for the design of models that will allow the organization to effectively utilize its volumes of historical data to make informed decisions regarding account profitability, client trending, process nonconformance, strategy effectiveness, staff allocation, etc. This individual will propose strategic recommendations based upon data interpretation, presenting conclusions using ROI or other supporting methods. Position will also be critical in establishing enhanced internal management and external client reporting/dashboards to further differentiate CCS in the marketplace.
ESSENTIAL FUNCTIONS:
Develop models, using our third party database analysis tool, to extract data from CCS' host system for analytical review. Database tool allows drill-down capabilities to the individual account level.
Support CCS' Operations and Segment Managers in forecasting client performance, based upon pro forma estimations (new clients), actual performance, and "peer" review against other clients in the segment. Develop reports to display how actual performance is charting against plan, based upon daily/weekly/monthly recoveries. Direct Corrective Action/further management review based upon shortfalls to plan. Uncover potential reasons why performance is not trending as expected.
Create dashboard reports to show how client performs against others in their segment (e.g. % of disputes, % of mail returns, % of non-phones, % of direct pays, score banding of client placements, etc.).
Recommend strategy modifications based upon "probability" of recovery (e.g. accounts in the Medical segment, aged beyond 60 days, with scores below 600 liquidate 1%. Account process should be suspended when accounts reach this condition). Recommend optimal strategies based upon analysis of score banding, prior history of account activity (e.g. disputes), total investment on the account to-date versus expected recovery for an account with that profile (probability) together with the client's unit yield (individual revenue per account).
Using control sets, determine which strategies are most effective after champion/challenger testing. Determine which strategy components were most effective at motivating payment (e.g. which notices in the series, which telephone calls, their timing, and by what method right party contact, fully automated, live CSR, etc.). Determine which script branches prove most effective, etc.
Manage the utilization of workforce management software to recommend optimal staffing levels and shifts, based upon actual call performance data and the program's output. Suggest allocation of staff resources to most advantageous call campaigns, based upon interpretation of "best contact" days and times.
Serve in a perpetual consulting capacity, mining data and drawing inferences based upon supportable evidence.
Support all CCS business units as analysis needs dictate.
EXPERIENCE REQUIREMENTS
5+ yrs of Database analysis
Strong analytical background
Self motivated logical thinker
Experience with DI-DIVER software a strong plus
Ability to recommend strataegic enhancements supported by clear analysis, easily understood by management
Ability to present findings to management
Must be able to work in a fast paced environment
Excellent interpersonal and verbal/written communications skills.
Highly motivated, self-starter, organized and detail oriented.
Work well individually as well as part of a team.
Coachability: Being receptive to feedback, willing to learn, embracing continuous improvement and is receptive and responsive to change
.
EDUCATIONAL REQUIREMENTS
Bachelor's degree in Business or related field MBA Preferred
5 Years of Directly Related Experience in lieu of advanceddegree.
Job Title: Principal Clinical Data Manager for i3 Statprobe
Company: UnitedHealth Group
Location: San Diego, CA
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 focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. The company demonstrates leadership and innovation by leveraging world-class process design and six-sigma quality, affording clients the ability to maximize efficiencies and exceed customer expectations.
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 are currently recruitingPrincipal Data Managers.
This position helps oversee data management operations and is responsible for supporting Management with hiring, supervision and training of data management personnel. The Principal Data Manager must ensure that activities and processes performed are conducted according to i3 and sponsor requirements. This position works closely with the data management and biostatistics teams, as well as clinical operational project teams. This position requires expertise in time and resource management, customer service and communications skills, project management, implementation of new technologies and data management processes.
Responsibilities:
Hire Data Management departmental personnel.
Evaluate and monitor departmental resources and plan resource allocation for all projects.
Train data management personnel in following GCP guidelines and standards, as well as establish good working practices.
Manage projects (including but not limited to Alliance Projects) and the resources necessary for their successful execution.
Responsible for creation, review, approval and maintenance, of all required trial data management documentation (DMP, all applicable forms etc.)
Assist in the development of business development proposals related to Data Management.
Assist or lead establishing and maintaining divisional policies and procedures (e.g. Standard Operating Procedures and Working Practices).
Maintain effective employee relations by ensuring consistent business practices within the division.
Maintain an awareness of data management systems and processes.
Documents CRF completion guidelines and instructions and presents at investigator meetings.
Interact with other department heads to ensure process integration Report status of ongoing clinical studies to the senior management and/or sponsors.
Ensure that data deliverables receive appropriate quality assurance reviews.
Establishes and coordinates the timely completion of the database lock procedures.
Understands and follows the process if the database needs to be unlocked
Ensures adequate preparation for internal and external database and data management audits, can respond knowledgeably and confidently to issues or questions that arise during audits.
Send and/or communicates status reports to the client.
Work effectively with peers and sponsors, as needed.
May have some line management responsibilities (like resource management, performance management, hiring etc.
Be available to staff as mentor/trainer in all processes within i3 Data Management.
Ability to guide and counsel direct reports/mentees on their career development.
Thorough understanding of budgets and algorithms used in development of RAPT tool and can communicate out of scope requests to the project manager.
Stay abreast of information relevant to data management processes through literature reviews, attendance at meetings and conferences.
Facilitate global process harmonization with other i3 Data Management sites.
Qualifications:
BA/BS Degree in life sciences or an equivalent combination of education and work experience.
Extensive relevant clinical data management experience.
Demonstrated leadership ability.
Strong customer service experience required.
Ability to work in fast paced team oriented environment and lead multi-disciplinary/cultural teams.
Ability to prioritize projects and work loads and delegate.
Good problem solving skills.
Ability to work with managers and project managers on a variety of projects at one time.
Proficient in the use of the clinical data management systems used at i3 Statprobe.
Basic Programming Knowledge (for example SQL).
Understands the structure of structure of of an electronic medical dictionary and how auto encoding works.
Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH, GCP.
Diversity creates a healthier atmosphere: equal opportunity employer M/F/D/VUnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
Job Title: SAP - Enterprise Data Management
Company: Ling Technologies
Location: Atlanta, GA
Description:
Pls email your resume to Register to View -tech.comREQUIREMENTS: Bachelor*s degree. Must have experience in implementing, developing, and/or supporting enterprise data solutions. Must possess knowledge (5+ years) of SQL, Oracle, and/or DB2 relational database systems. Must possess an extensive knowledge (5+ years) of implementing at least one of the following: SAP MDM (including both versions 5.5 & 7.1). Must include at least 3 full lifecycle implementations. BusinessObjects Data Services (including Data Quality and Data Integrator). DESIRABLE QUALIFIACATIONS: Graduate degree. Experience with SAP Portals. Experience with SAP functional application modules. Experience with SAP BW and/or BusinessObjects BI multidimensional database systems. Experience with data migration projects. Experience in, and comfortable with, corporate dynamics.
Job Title: Data Coordinator
Company: Novella Clinical
Location: Durham, NC
Description:
BASIC FUNCTIONS: Provides expertise in processing, reviewing and assuring quality of clinical data collected. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Performs data management activities for single or multiple protocol programs. Conducts aggregate review of clinical trial data. Coordinates the query management system functions Peforms the final patient review and database lock activities. Coordinates the processing of central labatory data and other externally supplied data, and performs relevant review of externally supplied data. Reviews query responses and ensures data quality. May draft or update documents for the Data Management Plan Performs duties as assigned. KNOWLEDGE, SKILLS AND ABILITIES: Knowledge of clinical research process and methodology. Understanding of current GCP/ICH guidelines applicable to conduct of clinical research. Experience in performing data management procedures including data review, and the query process. Knowledge of relational databases. Knowledge of data acquisition and quality assurance procedures in the pharmaceutical industry. Ability to speak and write clearly at technical and management levels. Ability to work effectively and cooperatively with other professional staff members. Ability assume responsibility for daily details with a high degree of accuracy. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Very limited physical effort required to perform normal job duties. MINIMUM RECRUITMENT STANDARDS: BS/BA in one of the life sciences or related experience required. At least 1 year experience performing data management activities and developing data management tools in a clinical/scientific environment required. Efffective computer literacy and knowledge of relational databases required.
Job Title: Clinical Data Coordinator
Company: Location: Monterey, CA
Description:
Clinical Data Coordinator
? Salary: Negotiable
? Start date: August
? Location: Bay Area
? Maintain a project-level perspective on data management issues, activities and deliverables (i.e., reviewing protocols for cross-project consistency, identifying project-level standard Case Report Form (eCRF) modules, coordinating data management activities across protocols to meet overall project deadlines and objectives)
? Manage projects resourced externally via contract research organizations
? Provide early strategic input into protocol design focused on data management issues
? Lead the development of database specification documents (e.g. CRFs/eCRFs, Edit check specifications, etc.) adhering to project timelines by interacting with other functional area representatives and the Protocol Execution Team
? Advocate for the use of Clinical Data Standards during the development of database specifications
? Develop the UAT Plan for EDC Databases
? Coordinate the user acceptance testing of the operational database and data checking procedures
? Monitor the receipt of data to ensure that quality data is available for project milestones (i.e. decision analyses and database locks)
? Review and resolve data discrepancies generated by the system and issue manual queries as appropriate
? Coordinate the Data Review process for the Protocol Execution Team
? Interact with Clinical Data Management groups to ensure that project objectives are understood and met
? Monitor work performed by CRO or other vendors
? Perform related tasks as needed
Skills
? Excellent multi-tasking skills
? Strong problem solving skills
? Oracle Clinical and Medidata RAVE experience is required
? Excellent communication skills