We have a global pharmaceutical client looking to hire additional people to handle payments in their clinical contracts group. DESCRIPTION Responsible for the training of new Contracts & Grants Payments Coordinators. Provides training to study teams in regards to payment support and processes. Assist in the collection of data to provide metrics and accomplishments to management. Acts as liaison among colleagues within C&G and study teams to assist with complex issue resolution and/or guidance, as needed. Responsible for the management of the e...

The Sr. Drug Safety Associate will work closely with safety reporting team ensuring that Outbound Safety Reporting to Investigators/IECs/IRBs is carried out within agreed timelines and in line with all the applicable SOPs and regulatory requirements. The Drug Safety Associate will participate in projects and initiatives related to outbound safety reporting, in audits/inspections. Bachelor’s degree in a science or healthcare related discipline or equivalent. Minimum of 5 years pharmacovigilance experience or other equivalent clinical or pharmaceu...

The Drug Safety Associate will work closely with safety reporting team ensuring that Outbound Safety Reporting to Investigators/IECs/IRBs is carried out within agreed timelines and in line with all the applicable SOPs and regulatory requirements. The Drug Safety Associate will participate in projects and initiatives related to outbound safety reporting, in audits/inspections. Bachelor’s degree in a science or healthcare related discipline or equivalent. • Minimum of 4 years pharmacovigilance experience or other equivalent clinical or pharmaceutic...

The Clinical Project Manager is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable company to maximize efficient and timely delivery of clinical trials. This position is responsible for contributing to an industry leading site engagement team. The Clinical Project Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following: • Define and implement strategies for ...

The Clinical Project Manager is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable company to maximize efficient and timely delivery of clinical trials. This position is responsible for contributing to an industry leading site engagement team. The Clinical Project Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following: • Define and implement strategies for ...

We are looking for talented and motivated candidates to join the team and take part in this long term, dynamic project. The project will provide exposure across a variety of Therapeutic Areas with an organization that is on the forefront of adopting new processes and technologies, creating a unique opportunity for career growth and development. Critical to the project is the role of Global Trial Manager, who will be responsible for the planning and management of clinical studies conducted by Global Development through the leadership of the cros...

We are looking for talented and motivated candidates to join the team and take part in this long term, dynamic project. The project will provide exposure across a variety of Therapeutic Areas with an organization that is on the forefront of adopting new processes and technologies, creating a unique opportunity for career growth and development. Critical to the project is the role of Global Trial Manager, who will be responsible for the planning and management of clinical studies conducted by Global Development through the leadership of the cros...

We are looking for talented and motivated candidates to join the team and take part in this long term, dynamic project. The project will provide exposure across a variety of Therapeutic Areas with an organization that is on the forefront of adopting new processes and technologies, creating a unique opportunity for career growth and development. Critical to the project is the role of Global Trial Manager, who will be responsible for the planning and management of clinical studies conducted by Global Development through the leadership of the cros...

JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grants and contracts Principal Responsibilities: Responsible for drafting, negotiating, and finalizing clinical trial a...

JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grants and contracts Principal Responsibilities: Responsible for drafting, negotiating, and finalizing clinical trial a...

JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grants and contracts Principal Responsibilities: Responsible for drafting, negotiating, and finalizing clinical trial a...

We have a very well established pharmaceutical client and they are looking to add people to work with them in Pharmacovigilance/Drug Safety. Sr. Drug Safety Specialist Position Summary Will work closely with safety reporting team ensuring that Outbound Safety Reporting to Investigators/IECs/IRBs is carried out within agreed timelines and in line with all the applicable SOPs and regulatory requirements. Will participate in projects and initiatives related to outbound safety reporting, in audits/inspections and will act as key contact dele...

We have a very well established pharmaceutical client located by SFO airport and they are looking for people to work in Pharmacovigilance/Drug Safety in triage workflow, intake, submissions and drug safety quality. Drug Safety Associate Primary Responsibilities Submissions activities also apply to Ethics Committee (EC) reporting as well as distribution of Investigator safety letters. A dashboard that tracks compliance is handled internally via compliance metrics report and provided to the QPPV. Submissions activities include both ICSR...

We have a very well established pharmaceutical client located by SFO airport and they are looking for people to work in Pharmacovigilance/Drug Safety in triage workflow, intake, submissions and drug safety quality. Drug Safety Associate Primary Responsibilities Submissions activities also apply to Ethics Committee (EC) reporting as well as distribution of Investigator safety letters. A dashboard that tracks compliance is handled internally via compliance metrics report and provided to the QPPV. Submissions activities include both ICSR...

Quality Analyst Long term contract $21.24/hr. QC Analyst to be responsible for conducting quality control routine and non-routine analysis of raw materials, in process, and finished formulation enzyme products according to standard operating procedures. Job scope includes performing new method development, method improvements, and validation of enzyme activity determination or supporting assays. Responsibilities: - Conducts microbiological and analytical analyses according to standard operating procedures (SOPs). - Compiles data an...

Associate Scientist Long term contract $25/hr. High throughput enzyme screening and enzyme activity characterization assays. Activity and inhibition kinetics analysis, protein quantitation. Coordinate technical activities with minimal supervision. Summarize, analyze and interpret moderately complex analytical data. Achieve successful completion of deliverables with efficiency and adherence to time constraints. Skills/Languages (any must need requirements to perform job duties ie: lifting over 30pds, forklift Bachelors or Master’s degree in Bio...

PROJECT MANAGER Experience working FOR two or more CROs is strongly preferred. Ideally with at least one small or mid-size CRO. CTM candidates may be an option, provided they managed trials directly, rather than merely managing CRO relationships. ****************************** SUMMARY: Project Manager needed for 3-6 month contract-to-hire engagement involving clinical trial management responsibilities. DUTIES & RESPONSIBILITIES: * Undergo training related to study protocols, activities and quality compliance * Serve as primary liai...

The Associate Director will support and expand the clinical microarray program. Responsibilities: Serves as an expert for review, interpretation and sign-out of microarray results. Reviews, interprets and reports other assays used for detection of copy number variants such as MLPA and qPCR. Provides skilled management and interpretation of complex copy number variant cases Assists with improvement to analysis and reporting workflows Assist with training of analysts when new practices are established Manages laborat...

Location MA Job type Full-time Summary of Responsibilities Work to create/maintain library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the data standards targets. Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Standards Development Organizations (SDO) which impact data processing activities within Data Science and other R&D functions that proce...

The senior statistical programmer position will be responsible for manipulating large databases and generating reports using SAS to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large databases and observational research methods such as epidemiology and statist...

Marlborough, MA, PERM, onsite Senior Manager, Statistical Programming - Provide statistical programming support to clinical trials for regulatory submissions and various publications, posters, … etc. - Support the Biostatistics function in statistical analysis including generating analysis data sets, patient listings, tables and figures for clinical trials. - Develop and maintain the infrastructure for project files of SAS datasets and SAS programs. Essential Functions: 1. Provide statistical programming su...

- 6 month renewable and potentially long term contract - Remote - 20-30 hours per week - Small CRO client looking for a senior biostatistician with attention to detail - Will initially be working on Phase I PK study and then will transition to Phase II studies. - QC top end tables - Writing SAPs - Creating T,L,F shells - Answering programmers questions - Will interact directly with client - Attend team meetings

• As Manufacturing Chemist – API, you will execute GMP and non-GMP manufacturing production of intermediates and drug substance. • You will write and execute batch records, review SOPs, and maintain quality documents associated with manufacturing. • You will perform and execute scale-up activities for large scale GLP / GMP manufacturing projects, including familiarization and front run execution. • You will perform laboratory scale experiments in support of GLP / GMP manufacturing projects. • As Manufacturing Chemist, you will review GMP documents...

Develops and maintains pesticide product labels for submission to US EPA . Works closely with regulatory personnel to ensure labels are in full compliance with FIFRA (Federal Insecticide Fungicide and Rodenticide Act) and with state regulatory requirements. Coordinates label information with production and ensures accuracy. Essential Duties and Responsibilities: Prepare product labels for EPA submission, incorporating all required elements as per 40 CFR Part 156 and with full understanding of EPA’s Label Review Manual. Provide input for intern...

Molecular Geneticist and Cytogeneticist We are seeking applicants with following training and experience Molecular Geneticist – To initiate and develop a full scope clinical molecular diagnostic laboratory Clinical Cytogeneticist – To serve as the section medical director of already established Cytogenetics/FISH laboratory JOB RESPONSIBILITIES • The selected candidate will develop and maintain policies and procedures that guide and support Laboratory Services. • Assists in establishing and executing departmental long and short-term goals...

Overall Purpose: Responsible to work in close collaboration with the V.P. Clinical Research, Medical and Professional 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 products, as well as manage the organizational planning and operational needs of the Medical Affairs organization. Duties and Responsibilities: Medical Affairs: • Oversee development of post-marketing clinical development plans including phase ...

Overall Purpose: Responsible to work in close collaboration with the V.P. Clinical Research, Medical and Professional 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 products, as well as manage the organizational planning and operational needs of the Medical Affairs organization. Duties and Responsibilities: Medical Affairs: • Oversee development of post-marketing clinical development plans including phase ...

Clinical Research Associate Must have 2 years of site monitoring experience to be considered. Roles & Responsibilities General Activities: • Conduct clinical trial site visits including evaluation, initiation, monitoring and close out • Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems • Proactive site management including: o Building and maintaining solid and professional relationships with site staff o Facilitating subject enrollmen...

VISION: Growing, global company with multiple plants manufacturing specialty chemicals, seeking a degreed Chemist to formulate materials to aggressively grow sales with innovate products and with improvements to existing products. OPPORTUNITY: Seeking a degreed Chemist to development new product technologies and improve current products. Work closely with Senior Level Chemists, assist with scale-ups, prepare samples and maintain lab notebooks. REQUIREMENTS: BS or BA degree in a science, preferably in Chemistry, Polymer Science or Chemical ...

Marketing Product Specialist Bedford, MA Permanent position Competitive base salary and company benefits This Marketing Product Specialist position is part of the worldwide marketing department based in the in Bedford, MA. Under the direction of the Product Manager, Group Product Manager, Marketing Manager, or Director of Marketing, the Product Specialist initiates and manages project specific tasks, such as: marketing research, voice of the customer, market and segmentation analysis, product labeling, product brochures, technical support, tra...

RESPONSIBILITIES: • Molecular Genetics/Pathology • Ability to interpret the clinical significance of genomic variants • Ability to synthesize summaries on complex genomic mutation profiles • Ability to make complex scientific judgments • Provides consultations to care providers. • Write and sign molecular genetic reports summarizing analyses, results, and conclusions. • Works with laboratory staff to address clinical issues promptly. • Assist with the planning and implementation of the quality control and quality assurance programs. • Assist ...

**Dual boarded is preferred. We would like someone that can do a 75/25 split MDX/cytogenetics. A really good candidate for MDX only would also be considered. The Associate Director of Molecular Diagnostics assists with the strategic maintenance/development of the Molecular Diagnostic laboratory.** JOB RESPONSIBILITIES Writing and reporting: Cytogenetics / FISH /microarray cases. Assists in strategic development of the laboratory services. Assists in the development and implementation of polices and procedures that guide and suppo...

The person in this position is a licensed Medical Technologist (MT) or Clinical Laboratory Specialist in Cytogenetics (CG) who is responsible for day to day processing and analysis of Cytogenetic, FISH samples. The person in this position performs the standard duties of a Medical Technologist without assistance. JOB RESPONSIBILITIES Performs all duties of a Cytogenetic Technologist I without assistance from Medical Technologist III. Displays satisfaction clinical competency on standard procedures. Must perform within the productivity ex...

Prepare and review regulatory documents related to IND submissions and will be responsible for executing the regulatory strategy Will be responsible for tracking budget, invoices and contracts with CRO’s, Consultants and/or contractors as appropriateContributes/authors/reviews clinical, CMC and nonclinical components of eCTD modules for INDs and briefing documents. Prepares and manages submissions (CMC, Clinical, nonclinical; amendments, supplements and briefing materials) that are technically complex and require extensive interaction with de...

1. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs. 2. BS or MS in Chemistry or Pharmaceutical Sciences, or related field is preferable Minimum 1-5 years of experience...

Report to a Senior ME who will guide how to provide mechanical engineering expertise from product prototype and development through commercialization. Will also learn how to provide product design guidance and consultation support on commercialized product. ESSENTIAL DUTIES AND RESPONSIBILITIES • Design and develop new products, components or accessories, define requirements and support selection of production/commercialization process. • Provide continuing product support for manufacturing, regulatory and quality on design requirements, custom...

The Senior Software Development Engineer will be a contributor to the development team, developing software for the Integrated Respiratory Information System, Business Intelligence, and other applications. This position will work as a software development engineer and and help define product specifications, and design, implementation and testing required to effectively allow the applications to consume respiratory medical device and related 3rd party data stored in the SQL data base. As the person in this role develops more experience he/she will pro...

- 12 month renewable contract - Remote Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large observational databases (e.g., administrative claims and electronic medical records) and observational research/epidemiology statistical methods is strongly desired. Experience with the Hadoop data storage platform and the OMOP Common Data...

Location MA Job type Full-time Summary of Responsibilities Work to create/maintain library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the data standards targets. Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Standards Development Organizations (SDO) which impact data processing activities within Data Science and other R&D functions that proce...

Position: Quality Validation Manager Status: Full Time Department: Quality KindredBio is a veterinary biopharmaceutical company dedicated to saving and improving the lives of companion animals. We are looking for highly driven individuals who will thrive in our results oriented, fast-paced environment. Position Summary: The Quality Manager will report to the Associate Director or Director of Quality Assurance. This position will manage the validation & quality related activities of clinical and commercial supplies for on-site manufactur...

Director of Data Standards, permanent onsite MA, competitive package: salary, bonus, stock options, 401K, relocation available.... Location MA Job type Full-time Summary of Responsibilities Work to create/maintain library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the data standards targets. Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Stand...

Responsibilities: • Selects, trains/orients and assigns department staff. Contributes to the development of the District standards of performance, evaluates performance, and initiates or makes recommendations for personnel actions. • Develop department goals and objectives, and establishes and implements policies and procedures for department operation. • Develops and recommends department operating budget in accordance with department goals and objectives and ensures that department budget is used as a guideline for operations. • Directs the prep...

Onsite - San Francisco, CA Direct Hire The Senior Biostatistician will provide statistical support (e.g., study design and data analysis) across all clinical studies, pre-clinical, and validation studies. The successful candidate will provide data mining for product development, global regulatory submissions, claims substantiation, post market surveillance, and tracking data optimization. These activities are in direct support of product approval for drugs. Responsibilities: Assist the Director of Biostatistics with the design and analysis ...

Onsite - Seattle, WA 6 month renewable contract The Contract Clinical Data Manager will provide data management support for company and partner clinical trials, including out-sourced activities. The Contract Clinical Data Manager will support/lead data management activities from protocol review, through CRF and Database design, trial conduct, and database lock. The incumbent will also have a role in the definition and refinement of departmental procedures and standards, all in accordance with GCP and company SOPs. BS/MS with 5+ years of industry...

Onsite - San Diego, CA Direct Hire _________________________________________________________ Senior Statistical Programmer Job Description This essential team member will be responsible for supporting the SAS statistical programming efforts for clinical and non-clinical projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards a...

- Onsite South San Francisco - 6 month contract to hire - Looking for a versatile programmer to help with a growing group at small biotech - Bachelor's degree minimum and 5 years of biotech or pharmaceutical statistical programming experience. - Extensive CDISC experience - Previous experience with SDTM data validation - Creating ADaM datasets (T,F,L) - Familiariity with ADaM and SDTM specifications. Big plus if able to write or modify SDTM or ADaM specifications

Senior SAS programmer - Onsite San Diego (will consider remote for ideal candidate) - 8 month potentially renewable contract * NDA submission, ISS and ISE , and CDISC experience required • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports)....

- Preparation of clinical specimens (i.e. bone marrow, peripheral blood and lymph node) for cytogenetic testing, which include setting up the specimens, harvesting, slide making and banding - Screening the G banded slides - Setting up FISH for hematological probes. Washing and screening FISH slides. - Primary responsibilities of a technologist are focused on routine specimen analysis and reporting of results. - Provide overall assistance to the laboratory staff at the discretion of the Laboratory Director or primary supervisor in order to improve ...

12 month renewable (potential contract to hire after 12 months)- Onsite San Diego with a very promising pharma client Description Responsible for collaborating with statisticians and data managers on the statistical programming strategy for multiple clinical studies. Serves as primary in-house programmer on multiple studies. Participates in the development of programming strategy for clinical studies, case report forms, database design, data management plans, programming specifications and statistical analysis plans. Responsible for production and...

Onsite - Seattle, WA 12 month renewable contract The Data Management Programmer I/II will perform data management programming for clinical trials as well as extramural partner trials. The Data Management Programmer I/II will support all platforms and integrations, and will primarily manage electronic data collection and access, all in accordance with GCP and SOPs. BS/MS and/or 8+ years of relevant industry experience. 3+ years of relevant experience in clinical data management and data management programming, oncology trial experience preferred;...