Pay Rate = $13/hour, 40 hours/week contracted for 1 year to start with potential for hire/extension. Benefits available. POSITION DUTIES: • Receipt of medical devices for possible repair and/or inventory purposes via SAP • Packages finished stock for shipment by identifying, pulling, packing, crating, loading, and securing product. • Shipment of medical devices for return to customer and inventory via SAP and info ship • Disinfection of medical devices • Maintaining inventory by identifying, labeling, and placing materials and supplies ...

Clinical Project Manager serves as a study manager for studies of moderate to high complexity from protocol development through study conduct and study closeout in compliance with Good Clinical Practices, and all National and Local Regulations Responsibilities: • Develop protocol • Interface with clinical data management and statistics in developing case report forms, managing data cleanup, and analyzing study data • Develop project budget/schedule in collaboration with Core Team and/or Program Management • Oversee site selection and training ...

Clinical Project Manager serves as a study manager for studies of moderate to high complexity from protocol development through study conduct and study closeout in compliance with Good Clinical Practices, and all National and Local Regulations Responsibilities: • Develop protocol • Interface with clinical data management and statistics in developing case report forms, managing data cleanup, and analyzing study data • Develop project budget/schedule in collaboration with Core Team and/or Program Management • Oversee site selection and training ...

Purpose/Objective of the job: To perform protocol level clinical data review and cleaning activities to support clinical trials and maintain protocol data quality Key Responsibilities and Major Duties: • Responsible for clinical data listing review at protocol level to ensure data submitted by investigative sites is of high quality and completed within predefined study timelines. • Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning. • Demonstrates an understanding of the indication studied and th...

Purpose/Objective of the job: To perform protocol level clinical data review and cleaning activities to support clinical trials and maintain protocol data quality Key Responsibilities and Major Duties: • Responsible for clinical data listing review at protocol level to ensure data submitted by investigative sites is of high quality and completed within predefined study timelines. • Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning. • Demonstrates an understanding of the indication studied and th...

Purpose/Objective of the job: To perform protocol level clinical data review and cleaning activities to support clinical trials and maintain protocol data quality Key Responsibilities and Major Duties: • Responsible for clinical data listing review at protocol level to ensure data submitted by investigative sites is of high quality and completed within predefined study timelines. • Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning. • Demonstrates an understanding of the indication studied and th...

Director of Laboratory Services- Reporting to the Hospital Administrators and Pathologists the Laboratory Director is a Clinical Laboratory Scientist, (CLS), licensed by the State of California Department of Health Services who has supervisory experience. The Director must have a broad knowledge of all areas of the laboratory; must be able to communicate clearly and concisely with all laboratory and hospital staff, Pathologists, and hospital administrators; must have a broad knowledge of laboratory management and personnel supervision. The Labora...

We’re working on behalf of a company that develops, manufactures, and markets life science analytical and preparatory systems for markets such as mass cytometry, high-throughput genomics, and single-cell genomics. The company sells to leading academic institutions, clinical research laboratories, and pharmaceutical, biotechnology, and agricultural biotechnology companies worldwide. Their systems are based on proprietary microfluidics and multiparameter mass cytometry technology and are designed to significantly simplify experimental workflow, increa...

Job Summary Supports the successful development, implementation, and improvement of manufacturing processes, to produce components and assemblies that meet customers’ requirements. Under the direction of the Operations Manager, and in cooperation with operations and engineering personnel, develops the necessary documentation, fixtures, tooling, and secondary process steps for the successful implementation, execution, and improvement of full scale manufacturing. Essential Job Functions • Knows and follows all safety requirements. • Under the dire...

This position is with an international pharmaceutical company. Most sites are local to Southern California. The Sr. CRA is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational sites and is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibi...

Job Scope & Purpose: Our commercially-successful Greater Boston area client is currently seeking an experienced leader to join their fast paced and growing Formulation Development team. This Associate Director/Director will lead a small team of scientists to advance candidates in a robust pipeline from development through commercial validation. The ideal candidate’s primary expertise will be in small molecule solid dosage development. Additional consideration will be given to candidates with expertise in alternative modalities or routes of administ...

Director, Compliance Mountain West Summary: This position resides in Mountain West regional office reporting to Vice President. This position is responsible for hands-on execution and/or oversight of quality personnel tasked with (1) establishing and/or maintaining Quality Systems and an eCompliance Program, (2) conducting and/or managing Regulatory Agency Reporting and communications, regulatory inspections (preparation, training, conduct, management, and responses), and maintaining internal and external quality standards through periodi...

Associate Director, External Manufacturing Quality Mountain West Region Summary: This role will reside in Mountain West regional office and will report to the Director, Quality Assurance. The successful candidate provides quality oversight of external contractors engaged in manufacturing pharmaceutical products on behalf of the organization, ensuring that his/her assigned products are manufactured, packaged, analyzed, released, stored and distributed in accordance with company standards and all applicable regulatory requirements. This in...

About The Opportunity: With multiple marketed products, our client believes that innovation should never stop in transforming the patients journey. They have partnered with multiple organizations that believe the same. They have worked diligently and strategically to identify and address various unmet treatment needs. They engage at all levels across the treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups in order to raise awareness and educate about this area of disease. ...

About The Opportunity: With multiple marketed products, our client believes that innovation should never stop in transforming the patients journey. They have partnered with multiple organizations that believe the same. They have worked diligently and strategically to identify and address various unmet treatment needs. They engage at all levels across the treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups in order to raise awareness and educate about this area of disease. ...

About The Opportunity: Our client is a publicly traded clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. This position is responsible for the development and maintenance of best practices, working instructions, and standard operating procedures to optimize Medical Information services around products. This person will author standard response letters and contrib...

Our client is a clinical stage publically traded pharmaceutical company focused on the discovery of drugs to treat patients with cancer. Summary: This position will coordinate clinical supplies for the company sponsored and Investigator sponsored clinical trials. Includes management of clinical supply inventories, oversight of clinical packaging and distribution vendors, planning and implementation of clinical supply packaging and labeling campaigns, clinical label development and coordination of clinical supply shipping and logistics activities...

Job Scope & Purpose: Our exclusive Cambridge based client is looking to add an Operations Associate to their early discovery team as their lab is growing and this is a key factor to their continued success. This small and passionate team is taking a novel approach to treating and targeting cells where DNA damage is apparent and could be a big factor in the future of clinical trials in the oncology space. The qualified candidate will help with lab supplies and ordering, assist with data collection, analysis, and related report generation, as well ...

 Supports clinical research team in research efforts by facilitating the protocol approval process and maintaining regulatory compliance throughout the trial's duration for research studies involving human subjects.  Establishes and maintains processes and monitors practices to ensure research involving Human subjects complies with regulations.  Researches and analyzes problems and takes a leadership role in resolving identified issues.  Disseminates information and coordinates or conducts training.  Provides direction and feedback ...

Overview: The Staff Statistical Programmer Analyst leads planning & execution across clinical programs and phases in support of regulatory submissions and publications.  Collaborates with the head of Statistical Programming in strategic planning and the discovery, development and implementation of applications, macros and other advanced programming techniques used for monitoring, analyzing and reporting clinical trials data. Establishes and maintains standards and compliant processes and systems. Duties: o   Adheres to departmental procedures...

About The Opportunity: Our client is a publicly traded clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products. Our client operates in a 2 billion dollar market! They are looking for a Senior Manager of Biostatistics which would be similar to most organizations at the Associate Director of Biostatistics level. This is a remote/ work from home position. As the Senior Manager of Biostatistics you will be responsible for all statistical aspects within a clinical development ...

About The Opportunity: Our client is a publicly traded clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products. Our client operates in a 2 billion dollar market! They are looking for a Senior Manager of Biostatistics which would be similar to most organizations at the Associate Director of Biostatistics level. This is a remote/ work from home position. As the Senior Manager of Biostatistics you will be responsible for all statistical aspects within a clinical development ...

About The Opportunity: Our client is a publicly traded clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products. Our client operates in a 2 billion dollar market! They are looking for a Senior Manager of Biostatistics which would be similar to most organizations at the Associate Director of Biostatistics level. This is a remote/ work from home position. As the Senior Manager of Biostatistics you will be responsible for all statistical aspects within a clinical development ...

About The Opportunity: Our client is a global leader in patient-focused medical innovations for various areas. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. They currently supply products and technologies to clinicians in nearly 100 countries around the world. As a Senior Biostatistician you will be joining an early-stage product development group which is focused on developing solutions f...

Work closely with Sales & Marketing to define gaps in company product portfolio and find new opportunities within the pressure sensitive industry that can provide growth for the company. • Work directly with customers to define customer wants, needs & potential customer value. • Develop new products that are robust in design and have strong financial returns. • Work closely with Purchasing and Manufacturing to assure product development initiatives are well managed from an overall cost perspective. • Be an internal technical e...

About The Opportunity: Our client is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class treatments for debilitating diseases. Working collaboratively, the company’s dedicated employees are focused on advancing novel therapeutics to dramatically improve the lives of patients. With purpose and passion, they have committed to making an important impact on serious medical illnesses. This role is for a Director of Clinical Data Management. This individual will become a part of the growing clinic...

About The Opportunity: Our client is a global leader in patient-focused medical innovations for various areas. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. They currently supply products and technologies to clinicians in nearly 100 countries around the world. This is a unique and challenging opportunity to join a group that is focused on acquiring, developing, testing, deploying and maint...

About The Opportunity: Our client is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. With multiple marketed drugs and exciting pipeline, the team is growing! This role is for a Senior Biostatistician who will primarily be responsible for statistical aspects in the design and analysis of clinical trials, including protocol development, statistical analysis plan, data analysis, data presentation and report writing. This per...

About The Opportunity: Our client is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. The Clinical Data Manager (CDM) is responsible for managing DM activities in the design, collection and lock of database for multiple phase I-IV clinical trials. As a member of the Biometrics group, the CDM will act as a member of clinical teams and interface with external CRO's and external vendors to fulfill many of his or her responsib...

About The Opportunity: Our client is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. The Clinical Data Manager (CDM) is responsible for managing DM activities in the design, collection and lock of database for multiple phase I-IV clinical trials. As a member of the Biometrics group, the CDM will act as a member of clinical teams and interface with external CRO's and external vendors to fulfill many of his or her responsib...

About The Opportunity: Our client is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. With multiple marketed drugs and exciting pipeline, the team is growing! This role is for a Senior Biostatistician who will primarily be responsible for statistical aspects in the design and analysis of clinical trials, including protocol development, statistical analysis plan, data analysis, data presentation and report writing. This perso...

About The Opportunity: With multiple marketed products, our client believes that innovation should never stop in transforming the patients journey. They have partnered with multiple organizations that believe the same. They have worked diligently and strategically to identify and address various unmet treatment needs. They engage at all levels across the treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups in order to raise awareness and educate about this area of disease. ...

About The Opportunity: With multiple marketed products, our client believes that innovation should never stop in transforming the patients journey. They have partnered with multiple organizations that believe the same. They have worked diligently and strategically to identify and address various unmet treatment needs. They engage at all levels across the treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups in order to raise awareness and educate about this area of disease. ...

About The Opportunity: Our client is a global leader in patient-focused medical innovations for various areas. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. They currently supply products and technologies to clinicians in nearly 100 countries around the world. As a Principal level Biostatistician you will be focused on developing minimally-invasive solutions for patients suffering from str...

About The Opportunity: With several marketed drugs and over 10 compounds in clinical trials, our clients ambition is to transform the lives of people living with severe diseases. They focus on various disorders – putting patients at the center of their world. They are Inspired by Patients. Driven by Science and they Listen. Their medicines treat thousands of people around the world and they are engaging with patients, their families and healthcare professionals to address their unmet needs. They want to enhance their understanding of disease and th...

About The Opportunity: Our client is a publicly traded clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products. Our client operates in a 2 billion dollar market! They are looking for a Senior Manager of Biostatistics which would be similar to most organizations at the Associate Director of Biostatistics level. This is a remote/ work from home position. As the Senior Manager of Biostatistics you will be responsible for all statistical aspects within a clinical development ...

About The Opportunity: Our client is a publicly traded clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products. Our client operates in a 2 billion dollar market! They are looking for a Senior Manager of Biostatistics which would be similar to most organizations at the Associate Director of Biostatistics level. This is a remote/ work from home position. As the Senior Manager of Biostatistics you will be responsible for all statistical aspects within a clinical development ...

About The Opportunity: Our client is a publicly traded clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products. Our client operates in a 2 billion dollar market! They are looking for a Senior Manager of Biostatistics which would be similar to most organizations at the Associate Director of Biostatistics level. This is a remote/ work from home position. As the Senior Manager of Biostatistics you will be responsible for all statistical aspects within a clinical development ...

Our client, an exciting and growing Ophthalmology pharmaceutical company, is currently looking for a Director, Medical Affairs to join their team! This position will be office based in Bedminster, NJ and relocation assistance can be provided for the right candidate. The Director, Medical Affairs is responsible to work in close collaboration with the V.P. Medical Affairs to align with the leaders of commercial operations, clinical and regulatory to execute the strategic efforts of Medical Affairs in support of pre-launch, branded and late – stage p...

Job Overview: The Project Manager fulfills the requirements of managing clinical trials (at the country or regional level, typically) to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget. In doing so, the Project Manager is responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicab...

Job Overview: The Project Manager fulfills the requirements of managing clinical trials (at the country or regional level, typically) to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget. In doing so, the Project Manager is responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicab...

JOB SUMMARY: Under direction of laboratory supervisor/manager/director, incumbent is responsible for efficient and accurate performance of difficult/complex cytogenetics laboratory testing, following established policies and procedures. This is the third level of a four-level job family. JOB RESPONSIBILITIES: 1. If job assignment includes tissue culture: Using SOPs, accurately and efficiently performs tissue culture of assigned specimen types, including culture initiation, maintenance, and harvest. Also performs slide preparation and staining for...

Job Scope & Purpose: Are you an experienced and passionate Scientist with abilities including design, implementation, and execution of Biochemical Assays in a High-throughput setting? If so take note of Stratacuity's amazing Oncology drug development client's new role. Don't miss this opportunity to work on a top-notch oncology team in defining the new standard in cancer drug discovery. This dynamic team is ideally seeking to add a Scientist that can work and collaborate with the Biomolecular and HT Screening Group, a pivotal team responsible ...

About The Opportunity: Our client is a global leader in patient-focused medical innovations for various areas. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. They currently supply products and technologies to clinicians in nearly 100 countries around the world. As a Principal level Biostatistician you will be focused on developing minimally-invasive solutions for patients suffering from str...

About The Opportunity: Our client is a global leader in patient-focused medical innovations for various areas. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. They currently supply products and technologies to clinicians in nearly 100 countries around the world. As a Senior Biostatistician you will be joining an early-stage product development group which is focused on developing solutions f...

The Clinical Research Manager  We are seeking a full time 5-7 years experienced clinical research manager in medical device, pharma and CRO. Candidate needs minimum a BA degree, managed CRA's and led research studies from initiation to completion.  Extensive experience in SOP creation and electronic data management Coordinates clinical operations including: Design, initiation, coordination of clinical trials to support regulatory submissions, as well as post-market clinical trials. In case of CRO managed studies: Leads CRO evaluation and s...

Key Responsibilities and Major Duties: • Responsible for clinical data listing review at protocol level to ensure data submitted by investigative sites is of high quality and completed within predefined study timelines. • Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning. • Demonstrates an understanding of the indication studied and the overall clinical data review goals in meeting the objectives of the protocol. Works closely with other protocol team members to meet the appropriate timelines for data ...

SUMMARY: Contract-to-hire engagement for clinical data management planning, execution, quality and other related responsibilities DUTIES & RESPONSIBILITIES: * Develop data management and data quality plan * Create Database specs and support vendor for database development, testing and management * Create queries and data check rules in conjunction with clinical research team * CRF design * Assist with additional clinical document design, data collection and data collection oversight * Support study reports * Team communications and presentati...

Job Scope & Purpose: Our exclusive Cambridge based client is looking to add two key members to their lab as their early discovery efforts are ramping up. With a novel approach to treating and targeting cells where DNA damage is apparent, these two Research Associate hires will be expected to contribute right out of the gate, work well with a small team, and learn new techniques quickly to drive this team’s diverse portfolio towards the clinic and patients. If you have seasoned skills in cellular and molecular biology, knowledge of mouse models, and...

Job Scope & Purpose: Our exclusive client, who was recently named one of the best places to work, is taking a unique biologic approach to rare disease that could bring an entirely new platform of therapies to these patients. With an internal culture that is unmatched, a streamlined early discovery screening platform, and new leadership with their eyes on marketed products – the time to join these team is undoubtedly now! They are looking for an Associate Scientist with a few years of direct HLPC method development and analysis experience in the c...