MUST HAVE 8-10 YEARS EXPERIENCE • Provide programming support for some or all of the following activities related to clinical trials data: Creation of SDTM and ADaM domains, statistical report generation, and program validation. • Communicate effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget. Proficient in SAS, SQL, or PL/SQL. KNOWLEDGE/SKILLS/ABILITIES (KSA’s): • Good communication skills and ability to supervise others. • Thorough knowledge of clinical trial statistical progra...

**FLOW CYTOMETRY JOB OPPORTUNITIES IN CALIFORNIA, TENNESSEE, TEXAS, GEORGIA AND FLORIDA** Perform daily flow cytometric processing for Leukemia/Lymphoma and PNH testing.A^ Utilizing the cytometer software, perform data acquisition of patient samples.A^ Assist, as needed, with data analysis of the processed samples.A^ Assist with routine maintenance and troubleshooting.A^ Perform daily QC/QA involved with the operation of the Flow Cytometry Laboratory.A^ Assist with validation projects. Job Functions: 1. Sample Preparation: Identify, lyse, a...

The Biostatistics and Data Management group is looking for a Biostatistician to support Clinical Development and Exploratory Sciences. This a position with high visibility for a qualified statistician with experience in the pharmaceutical/biotechnology sector, to collaborate in cross-functional drug development teams to develop and execute innovative statistics for the development of strategy and analysis of clinical trial studies. Responsibilities: • The incumbent will work with the VP of the development strategy and analysis, who will select and...

Your responsibilities will include: • Site Start-Up: works across several studies to ensure all required documentation is in place to authorize sites for study enrollment. Partner with other team members to support patient enrollment. • Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence. • Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with p...

Seeking a Clinical Laboratory/Medical Director for a genomics laboratory. This role is responsible for current and future clinical genomic testing provision and development. The selected candidate must possess a; MD, PhD or MD/PhD Appropriate experiences and expertise that would ensure success of the genomics laboratory The candidate must qualify as a CLIA laboratory director and be eligible for a New York State COQ. Specific expertise in clinical laboratory genetics is required and, in conjunction with an experienced scientif...

Permanent position Develop, implement and maintain end-to-end data standards from data collection to regulatory submission. Ensuring traceability throughout the data process and ensuring submission datasets conform to the data standards expected by regulatory agencies. Key Responsibilities Includes: Responsible for compliance with applicable Corporate and Divisional Polices and procedures Industry Standards - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and r...

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 Model also strongly desired. Strong doc...

Writing/implementing simulation programs after receiving requirements Proactively raise and ask questions Prior experience as the lead statistician with the ability to lead projects through completion Ability to understand clinical trial studies Good at both SAS and R programming Basic Qualifications: • Master’s degree in Statistics/Biostatistics or other subject with high statistical content with 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics o...

Description Technical review of raw data for the QC group Technical review of method transfer/verification protocols Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols Review, manage, and monitor stability trend tables Support investigations that arise in the QC testing of raw materials/finished products as needed Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scop...

Responsibilities Support the onboarding/qualification of new Microbiology lab Environmental monitoring of cGMP controlled areas. Total particulate count monitoring of controlled areas. Sampling and testing of pharmaceutical grade water. Microbial identifications, Growth promotion, Bioburden, Endotoxin, Biological Indicator, and Sterility testing. Support the onboarding/qualification of new Micro laboratory equipment Proficiently perform all qualified testing methods used by the Microbiology department. Perform all other duties assigned Qualif...

Our client, a global CRO, is currently looking for TWO senior clinical project managers with strong Oncology experience! Great opportunity to work part-time from home, and 2-3 days on site with a smaller, growing sponsor company. Best of both worlds for a work life balance! EXCELLENT, FULL TIME COMPENSATION package available for these roles! Job Responsibilities: Act as primary liaison with clients. Lead and direct cross-functional team leaders and third parties/vendors with some supervision and support. Manage project contractual deliverab...

Opportunity to work in the clinical trial agreements and contracts area for a leading global pharmaceutical company. 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 grant...

Opportunity to work in the clinical trial agreements and contracts area for a leading global pharmaceutical company. 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 grant...

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...

Opportunity to work in the clinical trial agreements and contracts area with a leading global pharmaceutical company. DESCRIPTION Responsibilities will include, but are not limited to, the following: Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol. Deliver clinical site agreements that protect company business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”). 1. Support G...

Opportunity to work in the clinical trial agreements and contracts area with a leading global pharmaceutical company. DESCRIPTION Responsibilities will include, but are not limited to, the following: Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol. Deliver clinical site agreements that protect company business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”). 1. Support G...

Opportunity to work in the clinical trial agreements and contracts area with a leading global pharmaceutical company. DESCRIPTION Responsibilities will include, but are not limited to, the following: Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol. Deliver clinical site agreements that protect company business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”). 1. Support G...

Objective of Position This strategic and collaborative role oversees site and other trial-related contracts. This role supports clinical development programs across all functional areas and is responsible for the management and processing of CDAs, Consulting Services Agreements, and Clinical Trial Agreements. Contracts are negotiated and completed in timely manner to meet clinical site activation timelines and functional deliverables. The contracts manager is accountable for working with internal and external partners to communicate challenges, ri...

Summary/Scope: The Clinical Trial Associate (CTA) in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors. Responsibilities invol...

The Clinical Trial 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 Trial 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 enga...

The Clinical Trial 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 Trial 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 enga...

Position Overview: Sr. Analyst – Clinical Functional Planning will be accountable for the day-to-day maintenance of data in planning systems (ex. Planisware / 1-Supply / Beacon / SharePoint / UCT / etc.). Under supervision of a group manager, he/she will support variety of operational activities (ex. functional detailed forecasting of work deliverables, drivers, names assignments, algorithms, reason codes, manual updates as needed). The candidate will use and maintain accurate functional project and non-project plans, track functional resourcing (FT...

Position Overview: Sr. Analyst – Clinical Functional Planning will be accountable for the day-to-day maintenance of data in planning systems (ex. Planisware / 1-Supply / Beacon / SharePoint / UCT / etc.). Under supervision of a group manager, he/she will support variety of operational activities (ex. functional detailed forecasting of work deliverables, drivers, names assignments, algorithms, reason codes, manual updates as needed). The candidate will use and maintain accurate functional project and non-project plans, track functional resourcing (FT...

Job Title: Executive Administrative Assistant Your role: As the Executive Assistant, you will provide high-level administrative support to the Executive VP and basic administrative support to the VPs team. In this role, you'll develop broad and comprehensive experience, skills and knowledge in organizational policies, procedures and practices. You will also facilitate and coordinate projects and deadlines directly or in collaboration with others. You will work independently, and carry out large scale special assignments, with minimal supervision. M...

Position Overview: Sr. Analyst – Clinical Functional Planning will be accountable for the day-to-day maintenance of data in planning systems (ex. Planisware / 1-Supply / Beacon / SharePoint / UCT / etc.). Under supervision of a group manager, he/she will support variety of operational activities (ex. functional detailed forecasting of work deliverables, drivers, names assignments, algorithms, reason codes, manual updates as needed). The candidate will use and maintain accurate functional project and non-project plans, track functional resourcing (FT...

Job Title: (TEMP) Assoc. Contracts Manager, Contracts/Sr. Contracts Administrator/Contracts Administrator Department: Legal Affairs KindredBio is a veterinary biopharmaceutical company dedicated to saving and improving the lives of companion animals. This position will be part of the legal team and reports to the Director of Legal Affairs. The position will be responsible for (i) ensuring that KindredBio contracts meet legal standards and client requirements, (ii) support in-house counsel and external counsel with various legal matters, includ...

Senior Manager, Statistical Programming, onsite, Marlborough, MA - 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 support to clinic...

Salary up to 140K, Willing to pay for relocation, Offers free paid time off the week in between Christmas and the new year, open to Visa sponsorship, However US citizenship preferred given the delay in start-time to sponsor individuals. This position is based in either site Tarrytown, NY, or Basking Ridge, NJ offices. Note: The other 'CNS' biostatistician position must be based in Basking Ridge 'only'. Summary: The Biostatistics and Data Management group is looking for a Biostatistician to support Clinical Development and Exploratory Sciences. Th...

The Lead Data Manager performs data management activities for both clinical and development projects. Ensures the delivery of complete, accurate data that is ready for analysis and regulatory submissions' defines and applies study-specific data requirements; participates in database planning and user acceptance testing of databased; and organizes and facilitates data entry and data management tasks to ensure timely, hlqh-qualitv deliverables. • Functions as Lead Data Manager for assigned projects, acting as the primary point of contact for...

+++This position will be 100% on-site+++ Lead and conduct all DM activities required for global clinical trials. Coordinate the work of global staff assigned to the project. Provide training on procedures and systems. . Create project-related materials. Track project progress and issue status reports. Ensure the achievement of key milestones relating to the function, such as completion of tasks towards final database. Attend internal and external meetings. May be required to participate in client, internal or agency audits and inspections M...

Our client, a growing global pharmaceutical company, is currently hiring a Principal Engineer, Implant Manufacturing based in their Research Triangle Park, North Carolina headquarters. The person in this newly-created position will be responsible for leading the manufacturing of their extended-release, sterile, ophthalmic products from early pre-clinical development through phase 3 clinical studies. Essential Duties & Responsibilities: This position will be responsible for leading the transition of drug product manufacturing processes from the for...

JOB DESCRIPTION Perform and direct procedures and functions within the Molecular Genetics department. Provides direct supervision of Molecular Technologists and the testing they perform. Maintains departmental QA/QC and inspection readiness. RESPONSIBILITIES Day to day supervision of test performance and testing personnel. Monitoring examinations to ensure that acceptable levels of analytic performance are maintained. Assure that all remedial actions are taken whenever test systems deviate from the laboratory's established p...

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...

- 6 month renewable contract- Pharmaceutical Client - Remote - Required to work pacific hours Required Previous Experience Includes: *Oncology experience required Creation of datasets and Tables or QC of these outputs Both safety and efficacy (AE tables all types, Lab shift tables, Exposure tables, PFS, OS, DOR, ORR, TTE) Experience in generating figures (Kaplan Meier, forest plot, waterfall) SDTM, ADAM, SAS 9.4, BASE, ODS, SAS/STAT, SAS/GRAPH, SAS Macro

The Clinical Trial 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 Trial 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 enga...

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...

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 ...

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 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...

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...

DOCS's is HIRING! Looking for home-based Sr. CRA's and CRA II's. f interested, please forward your resume to Diane Brescia, Sr. Lead Recruiter at DOCS. Her email address is diane.brescia@docsglobal.com. • Geographic requirements – Entire U.S (Must be 1 hour from major airport) • Therapeutic requirements – Will consider all Therapeutic areas • Experience requirements – Greater than 2 years Clinical Research Associate Educational Requirement: Minimum B.S/B.A Degree preferred.

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...

- 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 ...