MANUFACTURING PROCESS ENGINEER IV:  Location: Alameda, CA.  Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company’s environment to take an effective and proactive leadership role in a specific technical manufacturing discipline. Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks – tasks that may have multiple inter-coordinating elements. Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required. Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components. Interaction with peers and mentors on the individual’s projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities. Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering. Curriculum trains students in skills required to perform assignments. The individual will typically have had a minimum 2-5 years experience in an engineering discipline or advanced education to achieve the level of skill.  If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                                 Job #9288

PART TIME CLINICAL RESEARCH ASSOCIATE (CRA) - C:  Location: Lake County, IL. Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 5+ Years Experience Level. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                                 Job #9098

QUALITY ENGINEERING ANALYST:  Location: Alameda, CA. BA in Sciences. The incumbent will design and maintain a complaint tracking and reporting system; evaluate medical and non-medical complaints and stability investigation requests and make technical judgment on the nature of the problem; evaluate shipping, manufacturing, equipment, validation, engineering project, testing/inspection results, product specifications, employee training records as well as Basic Operating Procedures, SPC/quality trend data, and or stability reports, as applicable, to determine the root causes of the problem. The reviewer expert it own judgment based on experience to determine the depth of the investigation required associated the level of risk of non-conformance. Maintain a tracking and follow up-system to ensure compliance of Quality Engineering with the FDA Quality Systems Inspection Techniques. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.  
                                                                                     Job #9150

SR. MANUFACTURING ENGINEER:  Location:  Santa Clara, CA. This position includes work with ultra-fast lasers. Candidate must be able to create manufacturing documentation, provide line support, review R&D protocols, execute experimentation, and write R&D reports. Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company’s environment to take an effective and proactive leadership role in a specific technical manufacturing discipline. Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks – tasks that may have multiple inter-coordinating elements. The individual will typically have had a minimum of 4- 6 years experience in an engineering discipline or advanced education to achieve the level of skill. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                              Job #8608

VALIDATION ENGINEER I:  Location: Lake County, IL. Entry level candidates possessing a minimum of a BS degree preferable in the Science/Engineering fields. Verifies mathematical calculations of scientific analysis. Must understand and be able to interpret data and possess good oral and written skills. Must be computer literate, and detail/quality oriented. Will be trained to perform validation and prepare protocols in one or more of the following areas: facilities, utilities, equipment, computer, cleaning or methods. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.  
                                                                                         Job #9041

LAB TECH SR.: Location: Santa Clara, CA.  Conducts chemical and physical laboratory tests and makes qualitative analysis of materials, liquids, and gases. May also set up laboratory equipment and instrumentation required for the tests, research or process control. Must possess diploma or degree at the Associate or Bachelor level and 1+ years experience. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.  
                                                                                         Job #8953

SR. CLINICAL RESEARCH ASSOCIATE (CRA) - B:  Location:  Lake County, IL.  Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol, including planning study conduct, writing study protocols, designing CRFs, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CROs. Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate. 3-5 Years Experience Level. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282. 
                                                                                         Job #8952

CLINICAL RESEARCH ASSOCIATE (CRA) - C:  Location: Lake County, IL. Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 5+ Years Experience Level. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                               Job #8937

ASSOCIATE SCIENTIST I:  Location: Lake County, IL. Conduct investigations on internal nonconformances and customer complaints related to client. Assist in developing/ improving client manufacturing processes and/or products. Major Responsibilities: Design experiments and testing schemes, analyze data, write protocols and reports and present results to a cross-functional team. Must demonstrate strong problem solving and analytical skills and be a team player. Must possess a BS in molecular biology, biochemistry, or related field with at least one to two years of relevant experience. Knowledge of GMP, ISO, and FDA regulations and audits a plus. Familiar with process and test method validations. Excellent communication skills. Shall be able to perform under pressure to meet project deadlines. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.  
                                                                                         Job #8936

MEDICAL REVIEWER/SAFETY REVIEWER - C:  Location: Lake County, IL. Responsibilities include medical review, which involves review of Case Report Forms (CRFs) or eCRFs, including querying and query resolution, processing SAEs, narrative writing, QA of data listings, laboratory review, and MedDRA coding review. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                               Job #8929

CLINICAL RESEARCH ASSOCIATE (CRA) - B: Location:  Lake County, IL. Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 3-5 Years Experience Level. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                                 Job #8838

R&D TECHNICIAN - I: Location: Lake County, IL. Analyzes verbal or statistical data to prepare reports and studies for use by professional workers in a variety of scientific areas. May be proficient in qualitative and/or quantity. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                               Job #8837

CLINICAL RESEARCH ASSOCIATE (CRA) - C:  Location: Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 5+ Years Experience Level. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                                 Job #8808

CLINICAL STATISTICIAN II: Location: Lake County, IL. Provide in-depth statistical expertise in the areas of; experiment, protocol, case report form design, data base structure, and analysis plan; collaborate with the medical groups to complete joint scientific reports and FDA overviews, including review of such reports to ensure accuracy and clarity. May also contribute to the decision for optimal study design and contribute to the proper use of statistical methodologies for a study. Must have clinical research experience. 5+ Years Experience Level. If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                                   Job #8461

CLINICAL SCIENTIST/WITH STRONG MEDICAL BACKGROUND (SR. LEVEL):  Location:  Santa Clara, CA.  REQUIREMENTS:  Clinical Trial Experience (Preferred: Post-marketing experience); Experience Writing Clinical Study Reports; Must be Local candidate; Participate in the development of study protocols, protocol amendments, clinical strategies, SOP, etc.; Support trial implementation; Prepare internal and external presentations; Interact with various study support groups, Provides scientific input, and assist in project deliverables.  Special Skills:  Minimum of 3 years experience in medical affairs or equivalent experience within pharmaceutical or medical device settings; Strong interpersonal skills; Excellent written and verbal communication skills; Good planning and organizational skills; Excellent problem solving ability; Medical or clinical experience preferred; Proficiency in MS Word, Excel, Power Point.  This is a 2 year contract position.  If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.  
                                                                                         Job #VM1 

CLINICAL RESEARCH SCIENTIST/PUBLICATIONS:  Location:  Santa Clara, CA.  The Clinical Research Scientist will be involved primarily with Clinical Publications as well as Investigator Sponsored Studies.  REQUIREMENTS:  Involved in the development of tactical plans for publishing projects (ie, propose project and process improvements to appropriate staff, senior clinical research staff, medical directors, and/or marketing managers); - Provide necessary clinical support for scientific and commercial organizations.  Serve as scientific resource to sales, marketing and clinical as appropriate; - Present scientific evidenct in support of customers developing statements, guidelines and protocols; - Work closely with project management to support the Investigator Sponsored Study (ISS) programs; - Maintain internal Clinical Publications and Investigator Sponsored Studies databases and clinical data repository through critical information data input on a consistent basis; - Serve as a main contact for Clinical Publication database; provide training and business process support for the software; - Perform administrative duties in a timely manner as assigned.  Special Skills: Strong analytical, conceptual and administrative skills; Significant technical expertise and learning ability required to maintain pace in the market; Exceptional communication skills both oral and written; Excellent problem solving ability; Effective project and time management skills; Tenacity and perseverance to help overcome customer resistance; teamwork is mandatory requirement as it involves internal/external networking and across the commercial franchise; Ability to work extended hours (early morning 6-7am teleconferences with European team); High sense of urgency and commitment to excellence in the successful achievement of objectives; Excellent planning and organizational skills; Resourcefulness and demonstrating technical kowledge; Program execution.  This is a 2 year contract position.  If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                Job #AP1 

CLINICAL DATA MANAGER:  Location:  Santa Clara, CA.  REQUIREMENTS: -Bachelor Degree (minimum); -3 to 5 years experience; - Experience with Data Cleaning Activities; - EDC Concepts and Techniques; - Clinical Knowledge (cardiac preferred); - Responsible for clinical data management activities and operations for an ongoing clinical research study; - Contribute to an updated Data Management Plan (DMP); - Contribute to an updated eCRF Completion Instructions (eCI); - Timely creation of queries/data cleaning activities; - Assist.  BONUS SKILLS:  Experience with PhaseForward's Inform EDC Application; - Hands on experience with clinical data querying and issues resolution.  Special Skills:  Works on problems of moderate scope where analysis of data requires a review of identifiable factors; - Exercise judgment withiin defined procedures and practices to determine appropriate action. This is an 8 month contract position.  If interested, please forward your resume and salary requirements to recruiter@simoneaupartners.com or contact us at 203-404-8282.                                                Job #SS1