Life Science Professionals

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- Cambridge, MA

Junior role – 100% lab/bench focused work – could go perm Position Description and Specific Responsibilities The RA will support bacterial culture maintenance, organization of bacterial cell banks, reagent preparation, execution of experiments involving DNA extraction, PCR, gel electrophoresis, DNA sequencing and in vitro microbiological assays. QualificationsBS required. Educational emphasis in microbiology, immunology or molecular biology preferred.Highly motivated and organized individual.....


The CTA Specialist I will assist managing Clinical trials as well as help with biomarker and bio analytical specimen tracking and logistics across multiple clinical trials. As part of the Clinical Development Execution (CDE) team, the specialist will gain exposure to the planning of clinical trial and specimen collection. In addition, the specialist will interact with clinical site personnel, team members and the laboratories. Key Responsibilities Include:Assists with preparation of all....


GENERAL POSITION SUMMARY: The GTAG CTA will provide support to the GTAG Lead in the oversight and management of start-up activities for clinical trials. The CTA performs work within established protocols under general supervision. GENERAL RESPONSIBILITIES AND REQUIRED SKILLSRefer to key responsibilities section belowExhibits ability to ‘multi-task’ effectivelyDemonstrates a working knowledge of ICH GCP regulations, ICF’s and clinical protocolsAbility to interact well with various team members....


Specialist / Sr. Specialist Quality Systems, Quality Assurance Our client is a biopharmaceutical company committed to applying its scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic disorders. We are growing rapidly with a diverse robust pipeline We are searching for a dynamic Sr. Specialist Quality Systems to join our growing, Quality Systems team. The Sr. Specialist Quality Systems will be responsible for the daily administration of....


Key ResponsibilitiesReview all Quality Control (QC) related documents in support of finished drug products, drug substances, and stability samples, including specifications, method validation and stability protocols and reportsCoordinate and Trend stability data performed at external CMOs/CROsEnsure all QC activities are in accordance with regulatory and industry guidance’sPerform a thorough data review in a timely and effective mannerCommunicate any discrepancies, issues, or questions to the....


Scientific Programmer / Computational Biologist Contractor Our client is focused on discovering and developing novel drugs to treat cancer and rare genetic metabolic diseases, through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutics areas, They have multiple first-in-class lead product candidates in cancer metabolism and rare genetic, metabolic diseases in clinical and/or preclinical development. All....


Office Location: Cambridge, MA Our client is a biopharmaceutical company focused on discovering, developing, and marketing innovative therapies for debilitating and often life-threatening diseases. The clinical trials associated with these development programs will be performed on a global scale in coordination with Contract Research Organizations (CROs). These trials will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration


Job Description:Manages all aspects of the clinical trial data management process from study start up to database lock for Electronic Data Capture (EDC) trials managed in house and those contracted to Clinical Research Organizations (CROs)Responsibilities:Oversee day to day activities of data managers working on studies within a programParticipate in Clinical Development taskforces and initiatives around standardization and technology, as neededCollaborate effectively with other program leads....


The back-end data engineer will work with research scientists, computational biologists, and a front-end data engineer to help define and prototype applications that help to advance our client's drug portfolio by enabling the integration and visualization of information related to drugs, potential targets, and competitive intelligence. This will include data integrations using vendor-supplied applications and network visualizations of potential protein-protein interactions generated by a....


Clinical Trial Associates The Clinical Trials Associate assists the Clinical Project Managers in the conduct of trials and may be responsible for managing startup activities, vendor communication or other project activities as assigned. He/She performs work within established protocols under general supervision. KEY RESPONSIBILITIES: Advance those of the Clinical Trials Coordinator to include the following: Assists with preparation of all external and internal documentation, for assigned....


Our client is seeking a Temporary Clinical Information Management Coordinator II. The successful candidate will provide support for the Clinical Development Execution archive. He/She will assist in the management of the physical archive and will be responsible for document processing of a variety of documents in multiple formats. He/she will also assist in the management of moderately complex ongoing archive projects. In addition he/she will assist in fielding and processing requests from....


Clinical Operations Study Lead (COSL): The Clinical Operations Study Lead is responsible independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies. The Clinical Operations Study Lead is expected to address site and vendor related issues, with assistance as needed. KEY RESPONSIBILITIES:Responsible for managing approved trial budget(s)Develops and oversees study operational plan(s)Coordinates internal and....

- Boston, MA

GENERAL POSITION SUMMARY: The GTAG CTA will provide support to the GTAG Lead in the oversight and management of start-up activities for clinical trials. The CTA performs work within established protocols under general supervision. GENERAL RESPONSIBILITIES AND REQUIRED SKILLSRefer to key responsibilities section belowExhibits ability to ‘multi-task’ effectivelyDemonstrates a working knowledge of ICH GCP regulations, ICF’s and clinical protocolsAbility to interact well with various team members....


PRIMARY ROLE: The qualified individual will, under appropriate supervision, manage Regulatory Affairs activities for designated projects, prepare routine regulatory submissions, and perform regulatory research and regulatory intelligance as needed RESPONSIBILITIES: 60%: Will assist in preparing, compiling, reviewing and processing regulatory submissions in the US, including INDs/CTAs, BLA/NDAs, amendments/supplements, annual reports, study protocols, study reports, investigator brochures,....


Research Project Manager II The candidate should have strong data analytic skills and strong database management experience. This is an exciting and challenging position for someone motivated to work in an innovative academic cancer center on cutting edge genetics research. Responsibilities: · Oversees and conducts project management for all aspects of clinical trials; · Ensures quality and timeliness of all IRB and regulatory submissions and the dissemination of IRB policies within the....

- Cambridge, MA

Senior Clinical Data Manager Contractor Position description: Provide timely and professional management on the lifecycle of Phase I through Phase IV studies. Identify requirements for capture and processing of clinical data ensuring accuracy, consistency and completeness. Perform Data Management review and related tasks to result in databases that can be declared clean and locked according to strict quality standards. Provide clinical data management oversight of in-house and/or outsourced....

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