Key Responsibilities of Role • Oversight of Documentation in eDMS MasterControl. o Including uploading documents o Creating Infocards o Collaboration and Quality Checks o Training employees on use of MasterControl o Creation of courses for document training purposes o Writing SOP’s and Work Instructions o Administration of MasterControl • Processing Product Quality Complaints in IQVIA SmartSolve. o Reviewing complaints o Approving Evaluations and Investigations o Corresponding with Suppliers • Review and Approve Product Change, Rewo...

The Sr. Integration & BI Architect will work as part of a 5-person Oracle Applications team within a 3200-person world class Enterprise Architecture Group to assess the current and future needs around data management, integration and business intelligence technologies. You will develop, maintain & support scalable Integration, data management & business intelligence technology platforms and support model to meet the organizations current and future needs. You will perform high-level architectural design, development, and support for data management, i...

This position is responsible for the technical review of raw data, qualification protocols, Certificate of Analyses and other technical documents for the release of raw materials, finished products and stability monitoring • 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 aris...

The Clinical Trials Assistant (CTA) will support the clinical project team in the following areas: study start-up and site regulatory document collection; accurately update and maintain clinical systems within project timelines; prepare, handle, distribute, file, and archive clinical documentation and reports; review of study files periodically for accuracy and completeness; prepare, handle and distribution of Clinical Trial Supplies and maintenance of tracking information; track and manage Case Report Forms (CRFs), queries and clinical data flow. May...

100% Remote position- FTE. Must have excellent SAS and SQL experience, as well as extensive experience working with large, real world healthcare data. The senior 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...

100% Remote position- FTE. Must have excellent SAS and SQL experience, as well as extensive experience working with large, real world healthcare data. The senior 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...

100% Remote position- FTE. Must have excellent SAS and SQL experience, as well as extensive experience working with large, real world healthcare data. The senior 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...

100% Remote position- FTE. Must have excellent SAS and SQL experience, as well as extensive experience working with large, real world healthcare data. The senior 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...

Long-term remote FSP - West-coast based (pacific or mountain time) * Min. 12 (ideally 15) years of statistical programming experience. * Prior experience leading/managing projects/people is critical * Must have extensive experience with Kaplan-Meierplots * Must have great communication skills, ability to work independently Responsibilities will include, but are not limited to, the following: • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programmin...

Long-term remote FSP - West-coast based (pacific or mountain time) * Min. 12 (ideally 15) years of statistical programming experience. * Prior experience leading/managing projects/people is critical * Must have extensive experience with Kaplan-Meierplots * Must have great communication skills, ability to work independently Responsibilities will include, but are not limited to, the following: • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programmin...

Long-term remote FSP - West-coast based (pacific or mountain time) * Min. 12 (ideally 15) years of statistical programming experience. * Prior experience leading/managing projects/people is critical * Must have extensive experience with Kaplan-Meierplots * Must have great communication skills, ability to work independently Responsibilities will include, but are not limited to, the following: • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programmin...

primarily responsible for analyzing a client’s data to identify potential issues and gaps on company projects – so that they can be integrated into the key messages, documents, and presentations. Scientific / Regulatory Lead will be responsible for evaluating the scientific or regulatory environment to predict those topics, issues, concerns or desires that influence data interpretation (e.g., profiling, standard of care, evolution in scientific interpretation). They also provide clients with strategic recommendations that help enhance credibility of...

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 ...

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 ...

Serves as primary contact point between the sponsor and the investigational site. 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. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Ensure overall site management while performing tria...

Serves as primary contact point between the sponsor and the investigational site. 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. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Ensure overall site management while performing tria...

- 12 month renewable contract - Onsite New Jersey Projects: Project and Productivity Metrics Data collection and Reporting environments Other related tools and applications Role: You will build an Analysis and Reporting toolkit for use by internal teams in R Shiny / R Studio Connect to deliver best-in-class data collection, analysis and reporting products. In this role your projects will focus mainly on the development of a new front-end toolkit encompassing navigation, UI styles, data analysis, various data visualizations, back-e...

- Long-term remote FSP - West-coast based (pacific or mountain time), start date January 6, 2020 * Min. 12 (ideally 15) years of statistical programming experience. * Prior experience leading/managing projects/people is critical * Must have extensive experience with Kaplan Meir plots * Must have great communication skills, ability to work independently Responsibilities will include, but are not limited to, the following: • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and...

NEW Cytogenetic Director job opening in Colorado. (Active Status ABMG in Cytogenetics required). If you are interested please send your resume/CV to me at jfoster@stafficons.com and if you aren't interested, please send me a referrals information. $$If you refer someone to me and I get them hired I will pay you a referral bonus 30 days after the referral starts!$$ Please see job description below: (THIS IS AN UNOFFICIAL JOB DESCRIPTION) The Cytogenetics Director will be responsible for the management of technical and scientific operatio...

Perform site monitoring duties assigned for one or more trials. Participate in Study-specific training program, including review key study documents, participate in training sessions Conduct pre-study site qualification visits Conduct on-site study initiation visits to inspect and inventory clinical supplies, review protocol, AE reporting, Site Files, eCRFs and other study related documents Conduct on-site monitoring visits Participate in site escalation process as needed, including root cause analysis, CAPA, and follow through to resolution. ...

Responsibilities: In collaboration with Project Director, defines, develops and sets project timelines, budget, necessary procedures, staffing requirements and resources in various phases of projects. Directs and coordinates the staff and activities to ensure goals and objectives are accomplished within projected time-frames and budget requirements. Reviews status reports and modifies project schedules and/or plans as required. Prepares and presents project reports for management, clients, or others. Conducts clinical protocol training and Stan...

The Proposal Manager will assist the Business Development team in the preparation of proposal response documents associated with new business opportunities and will work closely with the Clinical SMEs, to prepare customized, comprehensive responses and budgets. Responsibilities: • Coordinate activities of proposal team members in preparing responses to Request for Proposals and Request for Information documents • Facilitate the preparation of proposal budgets. • Work closely with senior management, business development, project, and technical ...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our cl...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our cl...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our cl...

As a FISH - Laboratory Supervisor, you will have the overall responsibility for the planning, coordination, evaluation, and supervision of all technical and/or operational activities and personnel in the department. You will be responsible for performing duties to meet quality assurance, safety and accreditation requirements in the laboratory. The FISH - Laboratory Supervisor is also responsible for helping in the implementation of all area procedures and operations as well as ensuring that metrics established to measure quality, production and effici...

Senior Clinical Research Associate – Remote • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and con...

Senior Clinical Research Associate – Remote • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and con...

Clinical Site Manager • Experience Level 5 years Clinical Research experience (as centralized in-house monitor or onsite monitoring ideal) within multi therapeutic areas – particularly strong oncology or more complex diseases/trials (transplant, sepsis, HIV, etc.) • Degree requirements 1. Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy 2. Bachelor’s degree from an accredited university or equivalent. • Relevant Experience: 1. Thorough understanding of ICH/GCP guidelines and regulations as they relate to protocol/site mana...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monit...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the mon...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site act...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site act...

Responsibilities and Accountabilities • Demonstrates innovative design, development, and execution of process development projects through literature review and scientific teamwork. • Assess and interpret experimental data using DOE and statistical techniques. • Develops robust, scalable, transferable processes for upstream production of rAAV clinical gene therapy vectors. • Serve as a Subject Matter Expert (SME) for the development of robust, high performing upstream processes with emphasis on transferability to cGMP manufacturing and sup...

12 month renewable contract - Remote - The minimum education requirement is a Master’s degree in Statistics, Biostatistics or other subject with high statistical content. - Min. 2 years of pharma/biotech experience with a PhD or 4 years with a master's degree - Experience in hematology, oncology or immunology therapeutic areas (at least one of those areas) - FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines. - Experience working on study protocol, study design, statistical analysis...

Flow Cytometry JOB openings in FL. The Flow Cytometry Technologist is responsible for daily specimen processing in the clinical flow cytometry laboratory. Communicates with staff physicians and other staff employees regarding patient specimens. Works with management personnel to ensure efficient and technically correct systems and procedures in the clinical cytometry laboratory that includes QA/QC of reagents, instrumentation, proficiency testing, etc. Qualifications Bachelor's Degree in Clinical Lab, Chemistry, Biology or related field and com...

This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities: • Program analysis datasets, statistical tables, figures, and listings. • Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation. • Provide statistical programming and validation support for clini...

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 management, clinical operations, biostatistics, and programming and will oversee the work of statistics and progra...

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 partners. Prior experience with large ...

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 management, clinical operations, biostatistics, and programming and will oversee the work of statistics and progra...

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...

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...