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clinical research in Newark

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  1. Project  Physician

    Description The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex development program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team developing a new molecular entity currently being studied for central nervous system applications. Team matrix interactions include project planning, regulatory affairs, ...

  2. Director/Manager, Health Economics Outcomes Research - 1 year Contract

    Our client, a global pharmaceutical client, is seeking a Director/Manager, Health Outcomes Research for about 1 year.  The compensation is up to $84 an hour plus amazing benefits - medical, 401K with match, vacation and holiday. Job Role: • Supports the development of research projects with key opinion leaders and communication of data & research outcomes • Supports development of HEOR strategies and assist in creating tactics for economic value & quality of life arguments during product ...

  3. Contract Data Analyst/Associate Manager - Clinical/SAS

     Our client, a global Pharmaceutical Company, is seeking an experienced Contract Data Analyst for about a year.  The compensation is up to $64 an hour plus benefits - medical, 401K with match, vacation, holiday.   Job Role and Responsibilities: The primary responsibility is to conduct specific in-house HEOR studies across the entire portfolio. In addition, the incumbent also coordinates certain department-wide activities including but not limited to HEOR website, staff meetings, HEOR Research ...

  4. Biostatistician III - 105029

    Biostatistician III – 6 month contract  Designing clinical studies. Writing and reviewing statistical sections and other relevant parts of study synopses and protocols. Support study start up activities. Develop RAP, program TLFs, preparation for database lock, dry run and CSR activities. Review CRF, DB spec, VAP. Support analyses as required for decision making at project level. Support analyses and activities during submission and response to HA questions. Coordinate study tasks with ...

  5. Associate Global Correlative Sciences Leader - 105044

    Associate Global Correlative Sciences Leader – 5 month contract Contributes to Afinitor and PI3K programs' biomarker research by supporting the programs' Correlative Science Leaders. Key expertise includes familiarity with cancer genetic (breast cancer in particular), next generation sequencing (NGS), and PI3K/AKT/mTOR pathway. Requirements PhD in cancer genetics, cancer biology and molecular biology. Pharmaceutical industry experience is desirable, but NOT required. Knowledge in ...

  6. Senior Medical Writer

    Must have: Strong Phase III regulatory writing experience AND PK/PD Phase I writing experience Therapeutic area experience in: oncology and/or endocrinology Duties and Responsibilities   % of Time Provide medical writing support for development programs by hands-on writing of protocols, IBs, and CSRs. Participate in appropriate development teams and internal strategy and operations meetings. 60% Manage/Assist documents through the review process (coordinating ...

  7. Analytical Biochemistry CRO Administration Manager - Princeton, NJ

    Seeking Ph.D. in biochemistry, toxicology, bioanalytics or similar field and 10 + years of experience managing pharmaceutical development bioanalytics projects using Contract Research Organizations. Must have thorough knowledge of scientific operations, management, technical and administrative functions of the laboratory. Shall: *** Sources, qualifies, hires and directs CRO core activities, including method development, method validation and sample analysis for global regulatory submission. *** ...

  8. Clinical Research Scientist

     **BA/BS or advanced degree required! 3 years of experience required!** Duties:  -The Clinical Research Scientist (CRS) will support US efforts in the planning, execution and reporting of US CD&MA clinical trials in Oncology/Hematology/Rare Disease/Early Therapeutics.  -Responsible for the implementation of designated clinical trials including investigator selection, patient recruitment, preparation of trial related documentation (protocols, Case report forms, consent documents, letters of agreement ...

  9. Clinical Research Manager II- 94440

    Minimum Requirements: Prior experience with Implementation of clinical trials in the United States safety, data consistency, trial timelines, budget, resources, eligibility and enrollment.   Education: Bachelor Degree required   Job Description: Support US efforts in the planning, execution and reporting of USCDMA clinical trials in Oncology. Implementation of clinical trials in the United States (safety, data consistency, trial timelines, budget, resources, eligibility and enrollment), ...

  10. Senior Medical Writer (home based)

      Regulatory Medical Writer Must have written all of the following: NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms   Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical ...

  11. Senior Clinical Contracts Manager Consultant

    The Senior Clinical Contracts Manager (SCM) is responsible for assisting the clinical project teams with clinical vendor negotiation and executing all study contracts. This individual helps to prepare Clinical Trial Agreements and ultimately manages the contractual agreements. Develops study specific agreements and patient budgets with clinical study team.  Manages requests for vendor proposals, analyzes vendor proposals, negotiates vendor costs, and supports Clinical Project Managers with ...

  12. Sr. Research Investigator (Stability)

     As a Sr. Research Investigator in Stability you will contribute to establishing the stability study strategy for drug substances/drug products for assigned projects and guides teams on this strategy. Position is responsible for the design and authoring of stability protocols for large molecules and writing stability sections for Biologic Licensing Associations (BLA), using scientific and technical knowledge in accordance with global stability guidelines to support clinical use and registration of ...

  13. Sr. SAS Programmer

    Precept Life Sciences is currently seeking several SAS Programmers/Sr SAS Programmers for permanent position with our pharmaceutical client.  THESE ARE RELOCATION OPPORTUNITIES TO EITHER RALEIGH, NC or ELLICOT CITY, MD. RELOCATION ASSISTANCE PROVIDED. The individual will be part of the Research and Development Group (R&D) which is responsible for all FDA related research and supports all non-FDA company sponsored research. Responsibilities: Primary Job Responsibilities:   Program, update and ...

  14. GROUP LEADER

    Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to ...

  15. SENIOR SCIENTIST - BIOASSAY DEVELOPMENT

    Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to ...

  16. SAS Programmers

    Job Description:   Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways to support lead programmer in generation of analysis datasets, generation of TLGs (Tables, Listings, and Graphs), validation of aforementioned data and reports, and maintenance of study documentation Other ad hoc tasks as assigned Work Experience: ·         2-5 years related experience. ·         Experience is within the ...