Clinical Coordinator Jobs

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 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: 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: Clinical Data Manager Company: Aerotek Scientific Location: Rockville, MD Description: ESSENTIAL DUTIES AND RESPONSIBILITIES:- Coordinate the printing, shipping and receipt of CRFs in multiple studies/sites/countries.- Process, review, and query clinical trial data using Oracle Clinical database.- Generate, track, and resolve data queries using data clarification forms (DCFs).- Perform review of CRFs, issue manual queries as needed, and maintain archiving of CRFs in house.- Ensure that all processes for data entry and query resolution meet GCP requirements for the entry and reporting of clinical data.- Author edit checks, data quality plan, and data management plan.- Assist in the development of databases by assisting in the testing of data entry screens and code lists for clinical study data entry.- Design case report forms and annotated CRFs.- Interface with study site personnel to expedite resolution of queries and to improve quality of the data being collected. - Interface with laboratory personnel, CRF printing vendors, and other vendors as needed.- Prepare data transfer specs for vendors. Review lab data and immunology data transfers from vendors.ROLE FLEXIBILITY:It is understood that the incumbent will be expected to display some flexibility and, when pertinent, be able to work in other priority areas. Such transient changes in duties will not represent a change in status and will not place an onerous burden on the incumbent. SUPERVISORY RESPONSIBILITIES: NoneQUALIFICATIONS AND REQUIREMENTS:- Minimum of four years experience in the Pharmaceutical Industry (biotech, pharmaceutical company, CRO) in a clinical data manager position is required. - Experience with preparing data for submission for NDA or BLA. - Bachelor’s degree- Minimum two years experience using Oracle Clinical to enter and query data in a clinical database- Knowledge of EMEA and ICH regulations, CDISC, and FDA guidance- Able to apply GCP to work environment- Ability to review and understand study protocols and other clinical related materials - Ability to proactively address issues and to assist in setting project timelines- Proficiency with Microsoft Office software suite- Proficiency with auto-encoding, MedDRA and WHO-DRUG coding dictionaries- Knowledge of current technological developments/trends in data management, database construction, management, and retrieval methods- Ability to create edit checks, data capture and input specifications- Communicate effectively, both orally and in writing- Experience with EDC Systems a plus Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers. CompetenciesDesired:clinical data manager, EDC, GCP/ICH Contact Information Contact: Schaaf,Mary Jane --> Email this job Email: Send Email Now Address: US-MD-Rockville Phone: Register to View Fax: -- Reference Code: 1844145 Click here to see all

Job Title: Clinical Data Manager Company: Aerotek Scientific Location: Parsippany, NJ Description: Key Responsibilities- eCRF design- Validation check definition- Data discrepancy criteria definition- Data management plan development and execution- Ad-hoc and standard query generation- User Acceptance Testing of database - Data management status report generation- Monitoring and clinical report specificationsRequirements- BS or equivalent experience that provides the skills and knowledge necessary to perform the job- 5 - 8 years experience in Clinical Data Management- Experience in the critical care or cardiovascular areas preferred- Experience with EDC systems- Very good computer skills needed, particularly Microsoft Access- Knowledge of GCPs and other guidelines and regulations- Ability to multi-task- Good understanding of database design- Knowledge of the drug development process- Strong organizational and time management skills- Great attention to detail Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers. CompetenciesDesired:EDC Experience, Data Review Experience, 5 - 8 years experience in Clinical Data Management, Microsoft Access, Experience in the critical care or cardiovascular areas preferred Contact Information Contact: Calegari,Caroline --> Email this job Email: Send Email Now Address: US-NJ-Parsippany Phone: Register to View Fax: Register to View Reference Code: 1836488 Click here to see all

Job Title: Clinical Data Manager III Company: PAREXEL International Corp Location: Durham, NC Description: For over 25 years PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, we supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. We have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world. For more information about PAREXEL International visit www.PAREXEL.com. The Primary Clinical Data Manager's essential function is to independently organize and manage all clinical data management activities on projects (commensurate to their job role), being able to take on the role of DM Lead as required. Ability to solve problems using logical and systematic approaches is critical. Must have solid understanding of therapeutic indications and study hypothesis. Acts as consultant to CDMs and teams for data management issues and represents department at meetings and presentations. Possesses either an in-depth knowledge in all areas relating to project initiation, ongoing processing and lock, or be considered an expert in a specific area of data management. Work to the appropriate standards of quality and efficiency. Key Accountabilities ' Assume the ability to meet the requirements of a CDM I, II and III with a high degree of proficiency and autonomy ' Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to others in an open, balanced and objective manner ' Take on role of DM Lead, taking accountability for the full range or specific expert area of data management services. Ensure quality, timeline and productivity requirements are met or exceeded. Included in this are project planning and implementation, milestone tracking, organization and participation in team meetings, monitoring progress and providing updates as required ' Manage all phases of data management activities from study start up to database close ' Direct team members in daily activities ' Provide support and mentoring to project team members (including Primaries) on acceptable DM procedures, processes and concepts to ensure the highest standards of quality, productivity, planning, client service and compliance are achieved ' Provide input into improving and monitoring Data Management Standards and participation in continuous process / productivity improvement ' Facilitates cross functional team meetings and follow up on action points ' Actively review and provide feedback of study contract / BESTT and study productivity ' Recognize and manage out of scope activities and communicates to PM / line manager ' Represent PAREXEL to the highest of professional standards, both internally and in external liaison with clients, potential clients, competitor organizations and auditors ' Contribute to project bids as required ' Applies knowledge across multiple projects, clients and technologies. Position can be located in the Durham, NC or Waltham, MA office Job Requirements Skills ' Excellent interpersonal, verbal and written communication skills ' Client focused approach to work ' A flexible attitude with respect to work assignments and new learning ' Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail ' Willingness to work in a matrix environment and to value the importance of teamwork ' Carefully weighs the priority of project tasks and directs project team accordingly ' Shows commitment to project and departmental goals, motivating others to be successful ' Demonstrates working knowledge of industry practices within Data Management ' Looks for win-win solutions to solve problems ' Ability to make appropriate decisions in ambiguous situations ' Ability to solve problems by using a logical, systematic, sequential approach ' Proposes new approaches, methods or technologies to gain efficiencies and exceed customer expectations ' Anticipates how others will react to situations ' Ability to negotiate with respect and influence to achieve results ' Shares all important information with the project team ' Demonstrate a sound knowledge of all relevant regulations, including GCP ' Demonstrate a sound knowledge of internal CBOPs, CPs, Corporate Quality Manual, WSOPs and Operational Guidelines. Education ' Bachelor's degree and / or other medical qualification or relevant DM experience. Language Skills ' Excellent English written and oral communication skills. Minimum Work Experience ' Previous data management experience preferred, or clinical and / or research experience with solid understanding of clinical trials methodology and terminology.

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: CSG, Inc Location: Philadelphia, PA Description: An experienced clinical data manager is needed to support data management activities conducted at the Biostatistics and Data Management Core. Responsibilities include serving as the primary liaison with clinical and IT staff, supervising data research associates, and supervising and participating in case report form design, database definition, writing data validation checks, performing database queries, and reviewing and resolving data discrepancies. Ideal candidates will have at least 5 years of data management experience in a pharmaceutical, academic, or CRO environment, knowledge of regulatory requirements for FDA-regulated clinical trials, and progressively more responsible experience. Previous full-time data management experience, excellent verbal and written communications skills, organizational, analytical, project management, and multitasking skills are required. Experience in developing standard operating procedures, writing data management plans, supervising and training staff, and using Oracle, Oracle Clinical, or ClinTrial are a strong plus. Must have strong interpersonal skills and a proven ability to work in a team environment with clinical and systems staff. A bachelor's degree in a clinical or scientific discipline is desired; relevant work experience in lieu of educational requirements may be considered. Job Requirements BA/BS required with 3 plus years of solid data management experience in a Pharma/CRO environment.