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...

In-House Clinical Research Associate: As an In-House Clinical Research Associate you would be responsible for the following: • Monitor and report project-specific training compliance, for site and internal team. • Manage site/contact/study information using appropriate tool(s). • Review Informed Consent Form and assist with IRB submission(s) and review of IRB documentation. • Site Start-Up: work across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment. Partner with other tea...

Clinical Trial Assistant Acts as an in-house Clinical Research Associate providing support to clinical functions and site customers through site start up, enrollment, follow up and closure phases of clinical trial activities. • Site Start-Up: works across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment. Partner with other team members to support patient enrollment. • Experience following SOP’s in a quality environment • Experience working with CTMS system • ICF (Informed Co...

Our client, a great team and growing pharmaceutical company located in Bedminster, NJ is currently looking to grow their team! This position is a six month contract, expected to turn into a full time position in January, 2020. Contract Financial Analyst Responsibility: • Assist with the preparation, negotiation and finalization of clinical study budgets & forecasts tools, including analyzing major cost drivers • Manage Clinical and Medical Affairs Contract Agreement and Amendment process, interaction with sites, legal and compliance as necessar...

Our client, a growing ophthalmology company is seeking a Publications Manager, Medical Affairs for their great team! The Publications Manager, Medical Affairs is responsible for working in close collaboration with the Director of Medical Affairs to develop and execute a strategic publications plan and external scientific communication efforts in a GPP and compliant manner. They will work with Medical Affairs in support of pre-launch, branded and late – stage products, as well as support the organizational planning and operational needs of the Medi...

KindredBio is a veterinary biopharmaceutical company dedicated to saving and improving the lives of companion animals. The Manager CTM Elwood will manage the manufacture, inventory, availability, and distribution of all clinical trial materials produced at the Elwood facility. Responsibilities include, but are not limited to: • Forecast, track, and manage Clinical Trial Material manufacturing and supply chain, including o Raw materials coordination o Manufacturing operations o Packaging and labeling o Forecast/maintain/track/ inventory o Di...

Position Summary Work in conjunction with the Director who has the ultimate authority and responsibility for the specific genetics' division. Help provide direction and leadership for the administrative, fiscal, technical and scientific responsibilities of the division. Help ensure the safe and efficient operation of the division's clinical diagnostic service. Help provide consultative services at an institutional level to departments, divisions, committees, and cancer center (scientific staff within Medical Center and BRI) scientists, as well as to ...

DOCS is hiring! Are you looking for a company that values their employees and promotes work/life balance? If so, we are looking for Senior Clinical Research Associates/Senior Site Managers. A Site Manager is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. A Site Manager 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 Pract...

The scientist will conduct cell-based, whole organism, and biochemical assays to support diverse screening and optimization projects aimed at developing new treatments for various therapeutic targets. The position includes responsibility for conducting cell culture, parasites/organism rearing and manipulation, assay set-up, data collection, analysis and reporting. Experience working with parasites, other infectious disease agents or practical experience in manipulating tissues, cells or macromolecules in vitro to ask and answer biological and drug dis...

Clinical Study Associate This individual will provide support to the clinical study staff within Clinical Operations. Perform a variety of clinical research operations duties of a routine and technical nature in support of clinical trials. Supports project managers within the assigned clinical studies. • As directed, provides general support to the project teams which may include tracking study data, following-up with clinical sites on essential documents; assist in drafting and distributing study mailings, including study newsletters; assis...

Clinical Study Associate This individual will provide support to the clinical study staff within Clinical Operations. Perform a variety of clinical research operations duties of a routine and technical nature in support of clinical trials. Supports project managers within the assigned clinical studies. • As directed, provides general support to the project teams which may include tracking study data, following-up with clinical sites on essential documents; assist in drafting and distributing study mailings, including study newsletters; assis...

Responsibilities: • Develop and implement overall marketing and sales strategy, subject to approval by the owners • Focus on medical device markets o One-stop shop approach: company provides all services needed for your medical device:  Regulatory Affairs  Quality systems  Concept development/ideation  Product development – engineering through qualification, fully compliant with national and international regulations  Product approval – regulatory agencies in US, Canada, EU, other  Product safety qualification – Nationally Recognized T...

remote, contract biostatistician, one year renewable contract with leading pharmaceutical company Top 3 Must Have Skill Sets: • Software Development Life Cycle experience • Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS • Experience in assisting the safety team with aggregated analysis for signal detection for ongoing studies Day to Day Responsibilities: Within the first 30 days a ...

This position will work closely with the Head of Biometrics in identifying project demands and resource needs. This role will be responsible for leading the Biometrics team, which includes programming and data management, to provide strategic, scientific and statistical leadership to the assigned clinical development program(s), with guidance from the Head of Biometrics. This role oversees statistical aspects of assigned projects to ensure that scientific, regulatory and quality requirements are met and that plans are aligned with development goals. T...

Senior Statistical Programmer 6 month renewable contract Key Responsibilities Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic...

1 year renewable contract - Onsite NJ Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with standards Lead collaborative cross-functional team study build meetings for in-house and outsourced studies Review edit checks for in-house and outsourced studies Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and standards Participate in and lead team meetings when appropriate Act as primary CRO contact, when nece...

- 9 month potentially renewable contract - Onsite NJ CORE JOB FUNCTIONS: • Responsibilities will include analysis of clinical trial data with emphasis on translational data in addition to analysis of clinical, quality of life and of real world data. • Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support in the Medical Affairs Department, with emphasis on support of translational research. • Actively provide statistical support to the Medical Affairs Department. • This position coul...

- 1 year renewable remote contract The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external...

- 12 month potentially renewable contract - Ideally onsite NJ but will consider remote Responsibilities will include, but are not limited to, the following: • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. • Perform programming validation to ensure the qua...

- 12 month potentially renewable contract - Onsite Seattle Responsibilities will include, but are not limited to, the following: 1. Actively provide statistical support to the Clinical R&D Department. • Provide statistical input into the design of protocols including preparation of the statistical analysis section. • Prepare statistical analysis plans including table/listing/figure shells. Provide derivation for key variables and review data/programming specs. • Analyze and report results of clinical trials. Provide tables, listings and gr...

- Onsite San Diego - 6 month initial contract length CDISC Experience required NDA submission, ISS and ISE , big plus • 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). • Maintain complete and auditable documentation of all programming activ...

Clinical Trial Assistant - Remote This position will support the operational aspects of all client managed trials, both internally managed and outsourced trials, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting and closure). He/she will work in support of the Global Operations Head (GOH) Global Program Leader (GPL), Global Trial Leader (GTL) and Clinical Trial Manager (CTM) to track study timelines and trial budget, to support protocol and country feasibility, site selection, and trial and ven...

Clinical Trial Assistant - Remote Position This position will support the operational aspects of all client managed trials, both internally managed and outsourced trials, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting and closure). He/she will work in support of the Global Operations Head (GOH) Global Program Leader (GPL), Global Trial Leader (GTL) and Clinical Trial Manager (CTM) to track study timelines and trial budget, to support protocol and country feasibility, site selection, and tria...

Clinical Trial Manager Responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide. Responsible for leading cross functional clinical teams in support of the organization's business objectives for product development and/or commercialization. Possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area. Experience managing clinical studies who can get up to speed quickly, take ownership of projects and execut...

DOCS Global is the premier resource provider in the biopharmaceutical and medical device industries. We currently have an exciting opportunity available in Montreal Canada. The Senior Site Manager serves as primary contact point between the sponsor and the investigational site. A Site Manager 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 ...

• Routinely perform large-scale primary lung cell culture in 2D and 3D to support process development activities for a tissue engineered product • Assist with generation and maintenance of all master and working cell banks. • Follow prescribed laboratory methods and protocols under GLP/GMP-like conditions • Routinely perform media formulation in accordance to defined protocols • Routinely perform bioanalytical assays to phenotypically and functionally characterize cells (such as flow cytometry, IHC, protein analysis) • Execute process development...

Duties & Responsibilities: • Follow Sponsor’s training, instructions, and reference documents for accurate filing of trial documents into Sponsor’s TMF • Manage the workload for assigned trials (approx. 5-7) • Work with the Clinical Trial Manager and trial team to identify and maintain the country and site specific List of Expected Records (LoER) • Perform quality checks on filed documents according to current standards and instructions • Track filing activities and quality checking results using Sponsor’s provided tools and instructions • Sche...

The chosen candidate will: • Be a strong negotiator, able to identify cost savings through vendor cost reduction and consolidation • Provides daily leadership and supervision to procurement and planning • Be responsible for ensuring continued flow of materials and supplies using min/max, build to forecast and build to order principles. • Ensures that buyers and planners are following best business practices and is compliant with all Company policies. • Develops action plans and task assignments to improve supplier responsiveness, performan...

BASIC SUMMARY: Manage all technical and administrative development and execution of clinical trials/protocols for multiple and complex projects. Execute Clinical Operations functions in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs). ESSENTIAL DUTIES AND RESPONSIBILITIES: • Coordinates clinical study organization, implementation and management with the Sponsor and PharPoint Research management personnel. • Assists the Sponsor in writing laboratory specifications per study protocol and coordinating with...

I am reaching out to you to inform you, your friends, or colleagues of an Clinical Geneticist job opportunity available in Westchester County New York. *ABMG required and NYSCoQ* If any interest, please forward your CV or Resume to me via e-mail at: jfoster@stafficons.com or please send me the referrals contact info or please pass this message on to them. See brief job description below: MEDICAL GENETICIST JOB OPENING IN WESTCHESTER COUNTY NY (30 minutes North of NYC) An exciting opportunity to join an established Comprehensive Medic...

DOCS is hiring! Are you looking for a company that values their employees and promotes work/life balance? If so, we are looking for Senior Clinical Research Associates/Senior Site Managers. A Site Manager is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. A Site Manager 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 Pract...

Requirements: • ASCP Certification CT (ASCP), ORIGINAL CERTIFICATE MUST BE PROVIDED • 24 hours of continuing education every two years, Florida License. • • Baccalaureate degree or higher from a regionally accredited college/university, AND successful completion of a CAAHEP accredited Cytotechnologist program within the last five years. • Minimum 1 years’ experience • Competency and performance evaluated from Director through metric system evaluation

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

DOCS Global is the premier resource provider in the biopharmaceutical and medical device industries. We currently have an exciting opportunity available in Toronto, Canada. The Senior Site Manager serves as primary contact point between the sponsor and the investigational site. A Site Manager 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 ...

5+ years' experience as a CRO SAS Programmer CDISC experience (SDTM, ADaM, Define.xml) Experience leading multiple studies across multiple TAs. Experience with Sponsor interaction and bid process activities Experience leading a project team Conduct QC/Validation of SAS code Expertise in SAS language options including Macro language, BASE SAS, SAS/STAT and SAS/GRAPH BS/MS Math, Statistics, Computer Science, or related field

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...

- 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 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...

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...

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...

Cytogenetic/FISH Technologist job openings in Tampa, Cape Coral FL/California/Nashville TN/Houston TX. - 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 th...

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 - San Diego 12 month renewable contract Responsibilities will include, but are not limited to, the following: • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. • Perform programming validation to ensure the quality of analysis datasets and programming outp...

Onsite - San Diego 12 month renewable contract Responsibilities will include, but are not limited to, the following: • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. • Perform programming validation to ensure the quality of analysis datasets and programming outp...

On-site Boston area highly preferred Direct Hire Oversee a team of 5-10 SAS programmers; manage SAS programming timelines and resources and assist with personal development, training, and performance reviews. Provide statistical programming support to clinical trials by producing statistical analyses, including generating SDTM datasets, ADaM datasets, and tables, listings, and figures for clinical trials. Develop and maintain the infrastructure for project files of SAS datasets, SAS code, and supporting files. Support Data Management in dataset c...

FTE- On-Site S. San Francisco- Relocation assistance provided- great compensation package 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 Direc...