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clinical research in Boston

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  1. Clinical Trial Specialist (Contract)

    Clinical Trial Specialist (Contract)   Responsibilities: Conduct and facilitate specific start-up activities such as feasibility, site identification, pre-qualification, Site Regulatory Package (SRP) review and approval, Clinical Site Agreements (CSA) and Informed Consent (ICF) customization and negotiation (where required). IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs and study specific procedures.   Qualifications: Min 1 year of experience with ...

  2. 3887653 – Scientist I

      We are seeking to fill a contract position in Biochemistry and Bioanalytics group to contribute to the early stage oncology drug discovery research.   Responsibilities:   The successful candidate will be involved with the biological sample preparation and consequential analysis of molecules ranging from small molecule to proteome with advanced mass spectrometers to identify clinically translatable biomarkers and understand cell signaling network and mechanism of actions The primary ...

  3. Scientist I - (Biochemistry & Bioanalytics)

    Contract is approved until the end of the year (12/31/2014). Contracts with this company are reviewed at that time, and often extended.   Job Title :          Scientist I   Duties:  We are seeking to fill a contract position in Biochemistry and Bioanalytics group to contribute to the early stage oncology drug discovery research in Sanofi. The successful candidate will involve the biological sample preparation and consequential analysis of molecules ranging from small molecule to proteome with ...

  4. Manager Statistical Programming

     ~The Manager of Statistical Programming is responsible for the statistical programming aspects of projects for clients and project teams through management of internal staff. The Manager of Statistical Programming maintains optimal department processes, implements project-specific strategies, and assists with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs. The Manager of Statistical Programming assists with the ...

  5. Sr Clinical Research Associate - Oncology

    We have a top CRO client who is looking for a full time Sr CRA with Oncology experience anywhere in New Hampshire   Requirements/Qualifications:   ·         Registered Nurse certification and/or a Bachelor’s degree in nursing, pharmacy, life sciences or a related health field, or equivalent experience in healthcare.   ·         Minimum of 3 to 5 years of related clinical trial experience with a pharmaceutical company or CRO; prior project management experience desired.   ·     Coordinates ...

  6. Sr Clinical Research Associate - Oncology

    We have a CRO client who is looking for a Full Time/Perm Sr CRA with Oncology experience in the Boston area   Requirements/Qualifications:   ·         Registered Nurse certification and/or a Bachelor’s degree in nursing, pharmacy, life sciences or a related health field, or equivalent experience in healthcare.   ·         Minimum of 3 to 5 years of related clinical trial experience with a pharmaceutical company or CRO; prior project management experience desired.   ·     Coordinates/oversees ...

  7. Regional CRA (Boston, and Los Angeles)

     RCRA's needed in Boston, New Hampshire, Los Angeles  Must have Oncology monitoring experience ~~Description: The Clinical Research Associate manages all aspects of site monitoring responsibilities for clinical trials according to Good Clinical Practices (GCPs), company SOPs, ICH guidelines and study protocols, including pre-study, initiation, interim and closeout visits. Responsibilities:  Assists with study start-up activities.  Prepares study manuals, informed consent documents, regulatory ...

  8. Regulatory Affairs Project Manager

      ~~Hawkins Point Partners has an immediate need on its Cambridge, Massachusetts team for a Regulatory Affairs Manager with recent experience supporting FDA Clinical Trial Application (CTA) submissions. This person will ensure initial trial submissions, amendments, notifications and reports from internal and CRO or affiliate submissions.  Strong knowledge of the pharmaceutical clinical process along with analysis of regulatory issues and guidelines related to clinical trials is a core position ...

  9. PK-PD Contract Research Manager - Boston, MA

    Seeking 5+ years experience in Bioanalytical Research leadership and solid track record in Project Management to oversee and coordinate multiple CRO's on various PK-PD projects for global company. Shall: *** Develop and manage project timelines. *** Facilitate project review meetings, presentations and reports. *** Source, evaluate, contract, supervise and audit CRO's. *** Review data collection, analysis and reporting. *** Support technical transfers. *** Administer infrastructure ...

  10. Clinical Research Associate (Oncology)

    Job Responsibilities: Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance according to inVentiv Health SOPs and/or client guidelines Generate study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expense reports Recruit investigators for participation in clinical trials Conduct project feasibility assessments Negotiate study budgets with investigators Obtain, review for ...

  11. Clinical Project Manager

    Clinical PM Desired Skills & Experience •          College/University degree in life sciences, RN preferred •          At least 5 years of prior industry experience •          At least 2 years of experience at a position of Clinical Project Manager •          Previous CRO experience required •          Therapeutic experience - Oncology a plus. •          Participation in at least three clinical research projects in the capacity of a Clinical Project Manager •          Proficiency in standard ...

  12. Associate Scientist III, Bospecimens Management / Sample Processing

    Title: Associate Scientist III, Biobank Job ID: 4907 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 8 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate)   Job Details: The Biobank Associate Scientist III will design and manage all Biobank-relevant aspects of a Phase 0 clinical trial project and investigator-initiated pre-clinical research project as related to biospecimens needing to be collected, processed, labeled, shipped and stored. The ...

  13. ASSOCIATE DIRECTOR DMPK

    Our client is currently seeking a ASSOCIATE DIRECTOR DMPK. The Associate Director, Pharmacokinetics will provide strong PK and PKPD modeling and simulation leadership within DMPK Department. Looking for a Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology with focus on pharmacokinetics. At least Eight years pharmaceutical industry experience in pharmacokinetic and pharmacodynamics modeling support, including using SimCyp and/or Gastroplus PBPK, Phoenix WinNonlin, Phoenix NLME and/or ...

  14. Clinical Trial Leader

    Job Title:                        Clinical Trial Leader Department:                Oncology Translational Medicine         Job Purpose     Accountable for all aspects of assigned OTM clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials.   Major Accountabilities    1.        Lead the clinical protocol development process in collaboration with the Clinical Program Leader (team ...

  15. Biostatistician

       Permanent Sr. Biostatistician needed in Holliston, MA Job Description: -The Senior Biostatistician provides statistical input into Phase I - IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. The Senior Biostatistician can work independently and function as a lead statistician on clinical trials. Responsibilities include: providing statistical input into protocol and case report form (CRF) ...

  16. Associate Scientist III, Bio/Hazardous Specimen Management

    Title: Associate Scientist III, Biobank Job ID: 4907 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 8 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate)   Job Details: The Biobank Associate Scientist III will design and manage all Biobank-relevant aspects of a Phase 0 clinical trial project and investigator-initiated pre-clinical research project as related to biospecimens needing to be collected, processed, labeled, shipped and stored. The ...

  17. Clinical Research Associate II (In-House CRA)

    Clinical Research Associate II needed in Boston, MA Job Description: Partner with inVentiv Health Clinical to lend your Clinical Research experience to our Boston based client.  You will be responsible for ensuring that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.   Ensure that the rights and well-being of human subjects are protected and that the reported trial data is accurate, complete, and ...

  18. Associate Scientist III, Biobank

    Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis.   Title: Associate Scientist III, Biobank Job ID: 4907 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 8 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate)   Job Details: The Biobank Associate Scientist III will design and manage all ...

  19. Associate Scientist III, Bio/Hazardous Specimen Management

    Title: Associate Scientist III, Biobank Job ID: 4907 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 8 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate)   Job Details: The Biobank Associate Scientist III will design and manage all Biobank-relevant aspects of a Phase 0 clinical trial project and investigator-initiated pre-clinical research project as related to biospecimens needing to be collected, processed, labeled, shipped and stored. The ...

  20. Senior Informed Consent Coordinator

    Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis.   Title: Senior Informed Consent Coordinator Job ID: 4885 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 12 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate)   Job Details: The central contact for the Informed Consent (IC) ...

  21. Director, Clinical Data Management

    New England Research Institutes (NERI) In this dynamic role, the Director will lead NERI's data management group in several exciting new initiatives: a newly implemented EDC system and continued partnership with vendors in enhancing the system; participate in presentations and bid defenses toward new company initiatives, and lead the team to enhanced visibility both internally and externally. This is a highly visible and critical role within NERI. In this leadership role, the Director will work ...

  22. Vice President, Clinical Quality Assurance

    JOB SUMMARY:   The Vice President, Clinical Quality Assurance (CQA) is charged with the development and implementation of the company's Global Clinical and Pharmacovigilance Quality Assurance Plan in alignment with both business objectives and regulatory requirements.  Clinical Quality Assurancedevelops and implements all Good Clinical Practice (GCP) activities for the company and supports the Good Laboratory Practices (GLPs) related to research activities and clinical trial management. CQA ...

  23. Top Notch Project Managers with Bio-Pharmaceutical or Clinical Exp

    Are you a top notch Project Manager with experience working in the Bio-Pharmaceutical or Clinical Research Industry   If so, you may fit one of the  exciting opportunities we have available for Project Managers .   The Project Manager (PM) is responsible for overall project delivery. The Project Managers leads, plans, organizes and oversees all activities related to the execution of  various bio-pharmaceutical projects and clinical trials. The Project Manager provides customer-focused leadership ...

  24. Clinical Operations Lead

    Title: Clinical Operations Lead Job ID: 4852 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 12 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate)   Job Details: Partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. Leverage Phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program ...