Clinical Coordinator Jobs

Job Title: Clinical Data Manager Company: Adecco Medical & Science Location: Irvine, CA Description: Adecco Medical and Science offers excellent positions for all career levels. Please email your resume/CV to: Register to View and you may call me at Register to View . Please remember to tailor your resume to the job description. Thank you Mo Adecco Medical & Science, a leading provider of contract and permanent staffing in the Pharmaceutical, Life Science Technology, Medical Device, and Health Care industry is seeking an experienced Clinical Data Manager to work within one of our leading pharmaceutical clients in Orange County under contract. - Data management activities in support of clinical research studies. - Implementing Study Specific procedures compliant with Regulatory and internal procedures and requirements. - Supporting the documentation, testing, implementation, validation and utilization of systems and processes within the Clinical Data Management area. - Managing assigned project timelines and prioritization of tasks. Education and Experience Required - Degree and experience in Pharmaceutical, Medical Device (Life Sciences) or related fields with four to six (4-6) years of relevant pharmaceutical development and data management experience with a Bachelor's degree or equivalent. - Two to Six (2-6) years of relevant pharmaceutical development experience with a Master's degree or equivalent. - Required to have EDC (InForm ideally) experience within the last 24 months. - Experience in a medium to large pharmaceutical company or Contract Research Organization setting. - Project Management exposure/experience in a clinical data management environment. - Experience in presenting Data Management activities to various audiences. - Experience in coordination of multiple data sources and the interaction with their stake-holders both internal and external. - Excellent knowledge of EDC and clinical data management methodologies. - Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies. - Technical abilities and skills in the use and management of computer systems. Please email your resume to mo.ouranos Register to View adeccona.com Thank you Mo The Adecco Group is a Fortune Global 500 company and the global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions. Adecco Medical & Science is a division of the world leader in workforce solutions specializing in the recruitment of medical and scientific professionals. Our recruiters complete a certification program in their specific discipline, so they know their industry inside and out. And they use this understanding, along with their own real-world experience to connect top professionals with outstanding temporary, temp-to-hire or direct-hire opportunities. Adecco Medical & Science is an Equal Opportunity Employer. Apply Online About Adecco North America Adecco is a Fortune Global 500 company and the world leader in workforce solutions. Our comprehensive service offering includes temporary and contract staffing, permanent recruitment, outplacement and career services, training and consulting.

Job Title: CLINICAL DATA MANAGER Company: MedFocus Pharm. Res.Opp. Location: San Francisco, CA Description: CLINICAL DATA MANAGER COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Clinical Data Manager to work in San Francisco, CA Our client is focused on the rapid development of novel small molecule drugs to treat critically ill patients with serious diseases for which there are limited treatment options. RESPONSIBILITIES: Ensure the completeness, accuracy and consistency of the data so that it meets the quality expected for reporting to regulatory bodies. Involved in the setting up, running and reporting of clinical trials. process data using a range of computer applications and database systems to support collection, cleaning and management of patient data. Interaction with client and project team as necessary to establish data review guidelines and data flow procedures. Communicate/coordinate with the project manager, statistician, clinical research associate, database manager and clinical sites as needed to ensure accuracy and completeness of the clinical data. QUALIFICATIONS: Must have 7-9 years relevant CDM experience / clinical research experience. Minimum BA/BS degree. Must have Oncology experience. Good communication skills. 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: Clinical Data Manager Company: AVEO Pharmaceuticals Location: Cambridge, MA Description: Clinical Data Manager Aveo Pharmaceuticals, Inc. is looking for an experienced clinical data management professional. The incumbent will be responsible for handling data management on multiple global clinical trials. The incumbent will oversee CROs and ensure that the data management objectives are met in accordance with current SOPs and timelines. The incumbent will also provide assistance in protocol review and form design for newly conceived trials working either in the EDC or paper data management environment. Experience with data management on late stage oncology trials is strongly preferred. Responsibilities Oversee data management activities performed by CROs. o Review of CRFs for completeness, content, standards, and database considerations o Review of Database specifications o Review and Management of Data Management Plans o Perform data review periodically for quality issues and general data trends o Perform SAE review between CRF data and safety database o Oversee the management of non-CRF data for file format and timelines o Oversee the management of timelines of CROs Ensure adequate filing and archiving of relevant data and documentation. Work effectively as a team player with Biostatistics, Clinical, Medical, and Regulatory staff. Qualifications BA/BS degree or equivalent in a scientific or health care field preferred. Minimum of 5 years experience in clinical data management in the pharmaceutical/ biotechnology/ CRO setting. Knowledge of medical terminology required. Knowledge of coding dictionaries (MedDRA, WHO Drug). Excellent verbal and written communication skills as well as interpersonal and organizational skills. Attention to detail, ability to prioritize and handle multiple projects. Knowledge of Electronic Data Capture (EDC) and related tools and processes. Proficiency in MS Office applications. Proficiency with data management systems. Knowledge of database design and database concepts. Experience with lab data is a plus. Preferable but not required: SAS, SQL, Access. Occasional business travel may be required (domestic and international). AVEO Pharmaceuticals (NASDAQ: AVEO) integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The company's lead product, tivozanib, is an oral, triple VEGF receptor inhibitor with potential for a best-in-class profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEO's proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development that both increases the probability of clinical success and provides a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR. For more information, please visit the company's website at www.aveopharma.com. Please forward resumes to Register to View AVEO is an Equal Employment Opportunity employer that values the strength diversity brings to the workplace.

Job Title: Clinical Data Manager (6363) Company: Cubist Pharmaceuticals Location: Lexington, MA Description: 6363 Job Description Position Summary: Responsible for handling detailed Data Management issues, including oversight of CRO/Vendor data management activities for all phases of clinical trials (Phase 1-4). Minimum Basic Qualifications: BS/BA in a scientific discipline or equivalent A minimum of 5 years experience (2 years as a lead DM) as a Data Manager in a CRO or Pharmaceutical/Biologics/Medical Device company Demonstrated experience with an EDC data management system (e.g., Rave or Oracle RDC) Experience as lead CDM managing studies from preparation through close-out (including data management activities related to study conduct, study completion, and archiving of study materials) Provide oversight and participates in study setup and initiation procedures such as CRF design, database design, edit check design/review, DMP (Data Management Plan) review/approval and annotated CRF design. Familiarity with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODRUG dictionaries Experience Required: Contributed to the decision-making process involving data management (DM) issues for Phase 1-Phase 4 studies Ensured clinical databases, external data files and analysis datasets are designed in a standard, accurate, complete and consistent format conducive to analysis and a possible regulatory submission by working with lead CRO data manager or equivalent Developed Data Management guidelines and quality processes to ensure final database are accurate, complete and consistent Desired Competencies and Qualifications: AMaster's degree or coursework toward a degree preferred 2 years as a Data Management Project Manager in a CRO or Pharmaceutical/Biologics/Medical Device company Demonstrated experience with eClinical processes and procedures Demonstrated ability to facilitate communication among DM vendors/partners and the sponsor. Demonstrated ability to initiate and develop new and more efficient processes and procedures for study setup, maintenance, closure and archiving activities Developed/utilized study metrics to monitor project status, activities, timelines and budget and provided updates/recommendations to Manager/Sr. Management Developed documentation for regulatory submission and data analysis including SAS datasets, Data Definition Tables and submission-ready annotated CRF Participated in the review analysis tables/listings/figures and patient profiles for data consistency and accuracy Ability to work independently with minimal supervision Excellent written and oral communication skills Strong attention to detail Proficiency in basic SAS and/or JMP (preferred) or a demonstrated ability to learn basic programming skills is fundamental Familiarity with ICH GCP as well as general knowledge of industry practices and standards such as the CDISC data standardization initiative is also helpful Participated in other key activities to support data management, clinical, medical and biostatistics as needed Work Environment: Office setting with limited domestic/international overnight business travel Physical Demands: Position primarily involves sitting/working at a computer terminal; walking between offices. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Job Location Lexington, MA, US. Position Type Full-Time/Regular

Job Title: *Assistant Clinical Data Manager/Data Team Lead- Philadelphia, PA Company: Quintiles Location: Philadelphia, PA Description: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. 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 on timeline, 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 leadership and 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 justify out-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 orrelated field, with a minimum of 3 years experience in a clinicaldata managementrole, 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 theprojectlead. Candiate must have a thorough knowledge of the clinical trialdata 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.

Job Title: CLINICAL DATA MANAGER SPECLST. Company: MedFocus Pharm. Res.Opp. Location: Los Angeles, CA Description: CLINICAL DATA MANAGER SPECLST. COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Clinical Data Manager Speclst. to work in Los Angeles, California. Our client is a biotechnology company established to in-license and develop early clinical stage drugs, with a specific focus on the field of oncology. RESPONSIBILITIES: The CDM Specialist, due to the high level of data management expertise, will assume cross-trial responsibilities as appropriate, such as quality control, participation with therapeutic area standards development, and therapeutic area coaching/training. Additionally, the CDM Specialist may assume department/site level responsibilities (e.g. subject matter expert (SME) for a system or process; assistance to Functional Managers (FMs) or Data Management Leaders (DMLs) on various tasks; acting as DML for a startup compound or small Clinical Team). Lead one or more studies Obtain expert knowledge of trial protocol Accountable for all the Data Management deliverables Develop Data Management documentation, including but not limited to: Data Handling Guidelines Database Release Plan IDS Project Management tools Provide input or design of DCT, which includes but not limited to eCRF, eDiary, etc.. Provide DQR specifications, which includes listings Provide oversight of Data Management activities performed by executing party including but not limited to: User Acceptance Testing of DCT and DMT Project Management Data Review SAE Reconciliation Protocol Deviations Coding Perform QC, review and monitoring Database lock activities Monitor study metrics and status for on-going trials Provide input to the DML on study budget and resource needs Support GTM for Investigator Meetings and Monitor Training where applicable Actively participate as core SMT member and liaison to cross-functional trial team(s) Escalate issues to DML, GTM, cross-functional trial team(s) and/or executing party as appropriate Assist and support FMs and DMLs as requested Actively participate in internal/external staff mentoring and training Participate in Regulatory Agency and J&J internal audits when appropriate Perform oversight of Clinical Data Standards and best practices across studies and within therapeutic area. Subject Matter Expert (SME) for assigned business system/process for internal staff or external partners Keep updated with new industry developments in the area of Data Management Systems/Processes/Deliverables & Submission Requirement Actively provide feedback and participate in process/system improvement initiatives or evaluations in collaboration with other GCO/CDO or other groups (i.e. CDA, Clinical Data Standards Group, eClinical Services, QM&T, Stats and TCSM, etc.) This position requires full understanding of data management processes and policies and also a full understanding of the interfaces between data management and other functions. The CDM Specialist is able to work independently towards the assigned goals. The CDM Specialist will often assist in the definition of project goals and can independently make data decisions regarding the assigned trials. While processes and standards are foundations for many decisions, there is a high level of innovation and independence required. Because the CDM Specialist is working at the at the cross-trial level, the CDM Specialist has accountability for his/her actions at this level with little supervision. Additionally, the CDM Specialist must be able to recognize the cross-functional and departmental impact of these decisions. This position is the highest development level position in the Clinical Data Management ladder. The CDM Specialist reports solid line to the CDM functional manager and a dotted line to the DML. This position is also considered a development step towards Data Management Leader or Functional Manager. The CDM Specialist would be required to interact effectively with cross-functional teams, SMTs, and/or external service providers (ESP) in order to manage the data management deliverables at the trial level and also cross-trial level. Partner with the DML, providing project status, issue awareness, assistance with DML tasks, etc. When asked to participate on process and system improvement initiatives, the CDM specialist would need to interact with various CDO departments or ESPs. If performing cross-trial or therapeutic area standards oversight, the CDM Specialist would work closely with the Standards Management group to ensure the libraries are current by suggesting changes and updates and cascading the changes into team use. QUALIFICATIONS: BS/BA or equivalent work experience, MS/MA preferred. Life sciences background a plus 6+ years of pharmaceutical or health care experience, data management experience required 6+ years related experience Strong knowledge of Data Management processes and policies Technical Working Knowledge of Clinical Data Management Systems & Tools Strong customer focus Demonstrated ability to work in virtual team(s) Global Team player Strong project management skills Excellent written and oral communication skills Excellent organizational skills Effective in prioritizing and managing multiple tasks/projects simultaneously Excellent interpersonal skills Effective problem solving, negotiation and delegation skills Effective decision making and implementation skills Highly motivated Accurate, conscientious and thorough Innovative/Creative Awareness of cultural diversity Good knowledge of standards and libraries (global and compound) 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: Senior Clinical Data Manager Company: Makro Technologies Inc. Location: Boston, MA Description: Dear Candidate, We at MAKRO deliver custom client-centric solutions by offering contract outsourcing and premium staffing to the most well known life sciences organizations throughout the United States. Our broad geographic reach, scalability and immense talent pool enable us to reliably meet the needs of our esteemed clients. We thoroughly understand and believe that long lasting in-depth relationships with clients is an integral part in the business environment and equally important is the relationship with our candidates. Our vision is to become a most reliable 'connector' between Pharmaceutical, Biotechnology, Medical Device companies and Best Talent. Job position: Senior Clinical Data Manager Location: Boston, MA Position type: Contract Duties: Create data management plans for projects and manage the execution of these plans Manage clinical trials and patient registry programs through review, cleaning and auditing of clinical data and databases in compliance with SOPs, client guidelines, contractual obligations and regulatory agency guidelines Maintain clinical trial and patient registry data accuracy through review of data for completeness and consistency Develop and review electronic data edit checks Query data inconsistencies in compliance with standard operating procedures, client guidelines and regulatory agency guidelines Review database specifications and design/review electronic and paper Case Report Forms for new projects Prepare and/or review study reports, listings, tables, graphs and other presentations of study data Perform and/or review coding of adverse events and medications Skills: A minimum of 6 years experience in clinical data management with at least 2 of those years leading and managing data management projects and mentoring Clinical Data Managers Familiarity with medical terminology through formal medical terminology coursework or previous experience is required Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A a plus An ability to work independently, excellent organizational, communication and interpersonal skills are required Experience with coding dictionaries (MedDRA, WHO Drug) Experience with Electronic Data Capture (EDC) and the entire Data Management lifecycle. Education: Masters Degree preferred; Bachelors Degree may be considered with extensive experience in data management within a CRO, Pharmaceutical, Medical Device or Biotechnology setting Searching for more jobs? Visit at: http://makroscientific.com/makroscientific/Jobs/searchJobs.aspx For any reason, you are not able to submit your resume or for any further information, please call our Candidate Help Desk at Register to View or email your resume at Register to View . We shall be happy to help you. *** Makro is 3-time INC 5000 company for 2007/2008/2009 Makro is 3-time FAST 50 in NJ for 2005/2006/2007 (by Deloitte) ** Makro is 3-time FAST 500 in USA for 2005/2006/2007 (by Deloitte) ** Makro is NJ Finest for 2008 (by NJBIZ) We are an equal opportunity employer and your application will be considered without discrimination due to race, religion, gender, age, national origin, disability, veteran status or sexual orientation

Job Title: CLINICAL DATA MANAGER Company: MedFocus Pharm. Res.Opp. Location: Pittsburgh, PA Description: CLINICAL DATA MANAGER COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Clinical Data Manager to work in Pittsburgh, PA. Our client is a leader in the development of decision support tools and services that provide physicians with additional information for the treatment of cancer patients. RESPONSIBILITIES: A medical services company that is dedicated to providing physicians and patients with actionable clinical information to personalize cancer treatments is currently seeking a Clinical Trials Data Manager to participate in all aspects of clinical development and study management under the direction of the Director of Clinical Trials, or designee. Performs tasks related to all aspects of the clinical trial data management process from study start up to database lock for both paper-based and EDC trials and for trials managed in house and those contracted to CROs. Represents Data Management on Clinical Trial Working Groups. Works closely with CRAs, Managers, Bioinformatics, Statisticians and other staff as appropriate to develop CRF's to ensure the information required for statistical analysis is present. Identifies and resolves data flow process issues in collaboration with the project team. Defines data handling conventions, edit checks, quality acceptance and auditing criteria for electronic data as well as procedures for handling exceptions for violations to the standard metadata and identifies and requests additions to standard metadata. Assists with the development of EDC specifications, troubleshooting, and resolutions. Creates standard and ad hoc reports to efficiently identify outstanding queries, query types per site, etc. Creates ad hoc reports to identify and quantify patient cohorts of interest within the EDC Works with Clinical Trials team to resolve discrepancies and unresolved issues that arise during data entry. Assesses and reports on data outlier values. Identifies and reconciles SAEs. Identifies areas of manual data review where electronic checks are not effective. Uses available tools, systems and processes in support of the coding of medical terms. Communicates with vendors and collaborators to define required file format and content specifications for electronic files and establishes schedule and process for data transfers. Participates in the identification, review and evaluation of new data management technologies. Performs accurate database updates and follows up on query responses and errors identified in data cleaning. Drafts new Data Management Plans based on templates and Plans for similar protocol types. Documents database changes in the automated system audit trails and paper and electronic documentation. Liaises with third-party vendors such as CROs, EDC vendors and central laboratories. Monitors timelines to ensure data management-related deadlines are met. Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Process Guides related to data management activities. Participates in the development, validation and UAT of the EDC system Assists with training of site personnel and project team as appropriate and will work to ensure project moves forward based on both time and budget. Provide support as required to Corporate Compliance Program. General knowledge of all applicable regulations (GCP, ICH, CFR, OHRP, HIPAA). Assists with the development and/or maintenance of clinical trials infrastructure such as the draft and/or review of standard operating procedures. Assist with publication preparation activities. QUALIFICATIONS: Minimum Bachelors degree with a major in Data Management, Statistics, Computer Science, Life Sciences or a health related discipline; MS preferred. Prior experience working on a data management team at a CRO, pharmaceutical or device company. Prior experience working on EDC development, validation and UAT 1-3 years experience in an oncology-focused clinical/scientific data management role in research, or medical devices/pharmaceutical clinical trials. Prior experience working with SAS, or other statistical analysis software Ability to work in a small company environment Well developed and effective communication skills Highly developed interpersonal skills Proficient Microsoft Office Tools (Excel-Spreadsheets & Pivot Tables, Word, PowerPoint) Ability to maintain confidentiality Clinical Trials and Data Management Processes Clinical Trial Databases and Applications Ability to understand technical, scientific and medical information Excellent organizational and planning skills 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: Senior Clinical Data Manager Company: Location: Boston, MA Description: Pharmaceutical and Biotech Outcomes Studies Company is looking for a Senior Clinical Data ManagerPharmaceutical / Biotech/Research & Development Full-time United States - Massachusetts - Boston salary plus bonus and full benefits (see details below)LOCAL CANDIDATES IN THE MASSACHUSETTS AREA ONLY PLEASEThe Ideal Candidate 5 to 7 years of experience Management Experience Required - YesMinimum Education - Bachelor's DegreeWillingness to Travel - Occasionally Purpose: Manage database development and data review for clinical trials and patient registry programs in compliance with standard operating procedures, client guidelines, contractual obligations and regulatory agency guidelines. Manage and mentor Clinical Data Managers, Programmers and Medical CodersResponsibilities:-Develop and maintain general data management Standard Operating Procedures (SOPs) as well as study-specific SOPs and Working Practices (WPs) related to the data management needs of those projects-Create data management plans for projects and manage the execution of these plans-Manage clinical trials and patient registry programs through review, cleaning and auditing of clinical data and databases in compliance with SOPs, client guidelines, contractual obligations and regulatory agency guidelines -Maintain clinical trial and patient registry data accuracy through review of data for completeness and consistency-Develop and review electronic data edit checks-Query data inconsistencies in compliance with standard operating procedures, client guidelines and regulatory agency guidelines-Review database specifications and design/review electronic and paper Case Report Forms for new projects-Prepare and/or review study reports, listings, tables, graphs and other presentations of study data-Perform and/or review coding of adverse events and medications -Manage and assist with database quality audits as needed Requirements: -Masters Degree preferred; Bachelors Degree may be considered with extensive experience in data management within a CRO, Pharmaceutical, Medical Device or Biotechnology setting.-A minimum of 6 years experience in clinical data management with at least 2 of those years leading and managing data management projects and mentoring Clinical Data Managers-Familiarity with medical terminology through formal medical terminology coursework or previous experience is required-Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A a plus-An ability to work independently, excellent organizational, communication and interpersonal skills are required-Experience with coding dictionaries (MedDRA, WHO Drug) -Experience with Electronic Data Capture (EDC) and the entire Data Management lifecycle. Skills and Certifications (bold if required) EDC Additional Details The ideal candidate has worked for these companies:Other Clinical Research Organizations like Quintiles, PPD, Icon. Pharmaceutical companies like Merck, Novartis, Abbott.This company is a great place to work because:We consider our employees a key asset and a competitive advantage. We are always interested in qualified professionals in all areas of our rapidly growing company.Benefits:-Medical and dental insurance -A competitive paid-time-off policy -Company paid life insurance and long term disability-A 401K retirement savings plan with a company match Perks:-Flexible Spending account for medical and dependent care expenses-Subsidized Parking and Public Transportation -Tuition Reimbursement-Parental Leave Policy-Corporate discounts at Liberty Mutual, Aflac and other companies-A casual dress code -Friday morning breakfast-Annual Summer Outing and Holiday

Job Title: *Assistant Clinical Data Manager/Data Team Lead- Wilmington, DE Company: Quintiles Location: Wilmington, DE Description: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. 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 on timeline, 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 leadership and 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 justify out-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 orrelated field, with a minimum of 3 years experience in a clinicaldata managementrole, 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 project lead. Candiate must have a thorough knowledge of the clinical trialdata 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.