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our client is looking for a Clinical Trial Manager in Cambridge, MA. This is a long term consulting position. If interested, please apply to this ad or send your resume and contact details with the job # and job title in the subject line to [email removed] As a member or leader or leader of the Study Management Team, the Clinical Trial Manager (CTM) is responsible for applying Therapeutic Area expertise in the successful design and execution of highly complex, global clinical trials from the protocol ...

 The Director, Medical Writing oversees the smooth functioning of all medical writing projects for clients and project teams through management of internal staff and the medical writing process. The Director, Medical Writing, oversees the maintenance of optimal department processes and develops and implements project-specific strategies to increase productivity and quality.   Minimum Requirements The Director, Medical Writing has a BS/BA or advanced degree, with some applied training relevant to the ...

Senior 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 document (CTD) ...

This position is within the Clinical Assay Development group validating, and transferring clinical assays in support of Pharmacokinetics, Biomarkers and Immunogenicity of protein therapeutics. We are seeking a highly motivated individual to participate in validating analytical methods based on platforms such as ELISA and cell-based assays.  Additionally, this job is within a GLP-like setting and requires knowledge of working in a regulated environment as well as excellent verbal and written ...

Regional CRA opportunity! MUST have Infectious Disease experience. 2+ years of on-site monitoring. BS degree required. Good tenure with current/past companies.  

Clinical Data Manager Cambridge, MA. The Clinical Data Manager is responsible for overseeing data management tasks from study star-up through database lock..  Will be the point of contact for CRO's and other external vendors for all issues related to data management.  An emphasis will be on and coordinating, reviewing listing and output for an internal review of the data.  Minimum of 2 years on oncology studies.  Skilled in the use of EDC Systems (Rave preferred) and reporting tools. Overall ...

Provide strategic leadership for teams focused on the development of personalized medicine based on the discovery of molecular biomarkers. Utilizing patient derived data from genomic and molecular analyses you will develop strategies to drive oncology therapeutics through the clinic Shall: *** Work with clinicians and laboratories to develop novel biomarkers, research tools and study designs derived from the safety, pharmacokinetic and pharmacodynamic data obtain in the early phase trials. *** ...

  Title: Senior Clinical Trial Leader – MA – 3713463 Company: Pharmaceutical Company Location: MA Status: Full-time Consulting Engagement, 40 hours/week Length: Long-term consulting engagement in 6 month increments Our client is one of the largest pharmaceutical companies in the world and voted as one of the 100 Best Companies to work for by Working Mother Magazine. They are committed to peak performance, improving the quality of life, and ...

Title: Clinical Program Lead – MA Company: Pharmaceutical Company Location: MA Status: Full-time Consulting Engagement, 40 hours/week Length: Long-term consulting engagement in 6 month increments Our client is one of the largest pharmaceutical companies in the world and voted as one of the 100 Best Companies to work for by Working Mother Magazine. They are committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to ...

$5000 Hiring Incentive for qualified candidates! Experienced Clinical Research Associates (CRA) are needed US Nationwide!  Currently we are in urgent need for home-based CRAs with early clinical experience in oncology, respiratory, renal/hepatic, and general med.   If you have at least two years on site monitoring experience, authorized to work in the US for any employer and willing to travel at least 80% - I invite you to read our latest job need by following the link below.   Covance ...

seeking a technically skilled and highly motivated Assistant Laboratory Supervisor to provide technical support to staff performing moderate to high complexity testing of esoteric assays. As a member of our team you will be responsible for:  Cross-training laboratory staff on various testing platforms ensuring competency  Cross-validating assays on replicate instruments and/or methods  Coordinating the proficiency testing program for the clinical laboratory  Overseeing the validation and ...

Responsibilities: • The person in this function will be responsible for developing purification processes for manufacturing novel viral vaccine candidates for toxicology studies and Phase I/II/III clinical trials. • Execute experiments in close collaboration with Research and Technology Development team to establish Phase I-III clinical manufacturing process • Perform activities in support of definition of bulk purification processes for novel viral vaccine candidates (virus/virus-like particles, ...

Description: 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. Responsible for program level activities as assigned. Responsibilities: • Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical ...

Description: 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. Responsible for program level activities as assigned. Responsibilities: • Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the ...

Description: Support the operational execution of the clinical study strategies related to biomarker and pharmacokinetic assessments in oncology protocols, in compliance with client’s processes and regulatory requirements and in collaboration with Oncology Clinical Teams. Responsibilities: • Sample tracking for biomarker and pharmacokinetic samples from clinical site to analytical laboratory. • This includes setting up the laboratory procedures, being the primary point of contact and providing ...

our client in Cambridge, MA is looking for a clinical trial manager. If interested, please apply to this ad or send your resume and contact details with the job title in the subject line to [email removed] As a member or leader or leader of the Study Management Team, the Clinical Trial Manager (CTM) is responsible for applying Therapeutic Area expertise in the successful design and execution of highly complex, global clinical trials from the protocol concept through the clinical study report; ...

Seeking extensive clinical development experience to help guide discovery strategies and focus pre-clinical resources and efforts most effectively for big pharma research & development activities. Shall work closely with heads of multiple therapeutic areas and drug discovery units to drive clinical-to-preclinical backward collaboration in an effort to more effectively select targets and entities at the basic science, pre-clinical, and non-clinical stages. Requires MD-Ph.D, MD, or Ph.D and well ...

 Summary of Position The Health Care Economics Senior Specialist (HCES) is responsible for developing, implementing, and managing global economic and statistical outcomes research plans for a defined portfolio of medical device products within the major Medical Device Global Business Units (i.e. Surgical Solutions, Vascular Therapies and Respiratory/Monitoring Solutions).  The position also does analyses to support business development initiatives and programs across company.  The HCES will assist in ...

We are seeking a dynamic thought leader in oncology to develop pre-clinical biomarker strategies derived from clinical data analysis. You will provide scientific and strategic leadership to support oncology molecules in all phases of development. Shall: *** Oversee the development of biomarker strategies and ensure successful execution of drug-diagnostic development *** Leverage your expertise to drive the publication of biomarker data in high quality scientific, technical, and medical ...

Major developer of novel renal therapeutics seeks 3+ years experience and strong working knowledge of in vivo pharmacology techniques to: *** Prepare test compounds *** Handle and dose mice *** Collect blood and tissue samples for PK and PD biomarker analysis *** Establish PK-PD relationships from in vivo assays *** Generate human dose predictions for clinical development *** Assess the mechanism of action and therapeutic viability for novel renal therapies PhD Life Sciences, ...

Contract Length:  6 months - extension  Job Description:   • Collaborates with Clinical Research / Clinical Operations personnel to ensure that clinical trials comply with SOPs, FDA regulations, and ICH/GCP guidelines. • Provides expert GCP compliance and general QA support; acts as liaison between product development teams and QA. • Plans, coordinates and conducts internal and external (both domestic and international) GCP-related audits. • Assist in the development of the Quality Management System ...

Seeking at least 5 years coordinating quality assurance activities for good clinical practices, performing domestic and international inspections to ensure compliance to FDA regulations, IRB and IEC regulations and guidelines, site SOPs, protocols, and industry standards. Shall: *** Direct and coordinate GCP quality assurance activities. *** Author GCP documentation: protocols, case report forms, tables, listings, reports, and investigational brochures. *** Schedule and conduct Good Clinical ...

Seeking Ph.D. or M.D. and 10+ years in pre-clinical drug discovery and development for autoimmune, inflammation or respiratory therapeutic target entities including the development of in vivo, in vitro and ex vivo evaluation models. Shall: *** Participate in selection of specific protein & antibody entities as novel targets or drug leads for therapeutic consideration and develop research strategy. *** Supervise development of in vivo, in vitro and ex vivo evaluation models. *** Oversee ...

Seeking a scientific leader to oversee the development of preclinical models of inflammatory diseases to support clinical development collaborations, based on the pathophysiology of disease and the mechanism of action of drugs. Shall: *** Prepare, initiate, and manage all preclinical research studies *** Establish collaborations with pharmaceutical and academic organizations *** Manage a team of up to 10 Scientists Candidate must have 10+ years similar experience and possess PhD in Biology, ...

 Special Order Notes: 1.) Protein structural chemistry - characterization of protein variance Biophysical type candidate 2.) Analytical methods 3.) Enzyme structure function / Biophysical methods   Forced degradation studies (how the molecules break apart) Class of molecules in important and mechanisms of them.   Degradation pathway Kinetic studies LCMS Peptide mapping Reverse Phase Chromotography (No enzyme assay development)   Intercellular     Job Title:  Postdoctoral Scientist Location:   ...

Animal Technician Consulting Project Cambridge, MA [email removed] | 646.790.8355 As a member of the Veterinary Service Team this position will assist the Attending Veterinarian in Maintaining a comprehensive veterinary care and preventative medicine program for a variety of research species. Provide high quality clinical technical support in assisting in administering the health care ad preventative medicine program within the research facility to comply with all federal, state, and local ...

GxP Validation Project Manager Hawkins Point Partners has an immediate opportunity in the Boston area for a Senior Information Technology Project Manager with expertise supporting pharmaceutical, clinical research and development applications. The ideal candidate will have experience managing numerous complex initiatives for a Regulatory business group within the Biotech/ Pharmaceutical industry. The ideal person will must have experience working in a GxP validation environments. This person will ...