The position is ideally suited to a candidate with process chemistry experience in a contracting manufacturing environment. Account Manager Responsibilities • Manage projects brought in by the Business Development (BD) team for clinical development and production. • Be the direct interface for much of the correspondence between Company and Clients, as well as support the BD and technical teams. • Interact effectively with the Project Management Office (PMO) and other relevant groups to drive effective performance of projects. • Watch projec...

• 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...

This is a contract position through the end of this year where you would have an opportunity to work with a global pharmaceutical company. Job Description • Daily management, coordination, negotiation, and finalization of contracts, modification and task specification addenda for R&D clinical-trial related and outsourced services. • Review, prepare, and negotiate vendor agreements in a timely manner and in collaboration with Global Procurement category managers, R&D teams, and corporate legal. • Contracts and documents may include, but not be...

This is a contract position through the end of this year where you would have an opportunity to work with a global pharmaceutical company. Job Description • Daily management, coordination, negotiation, and finalization of contracts, modification and task specification addenda for R&D clinical-trial related and outsourced services. • Review, prepare, and negotiate vendor agreements in a timely manner and in collaboration with Global Procurement category managers, R&D teams, and corporate legal. • Contracts and documents may include, but not be...

This is a contract position through the end of this year where you would have an opportunity to work with a global pharmaceutical company. Job Description • Daily management, coordination, negotiation, and finalization of contracts, modification and task specification addenda for R&D clinical-trial related and outsourced services. • Review, prepare, and negotiate vendor agreements in a timely manner and in collaboration with Global Procurement category managers, R&D teams, and corporate legal. • Contracts and documents may include, but not be...

Our client, a startup pharmaceutical company is currently hiring and expanding their team! This is an opportunity to join a growing team in a fast paced, exciting environment where you can grow your career along with the company! This position is located in Philadelphia, PA. Regulatory Operations Associate The Regulatory Operations Associate role will support the Clinical Trial Manager/Operational Team in executing the trial(s) and maintaining effective communication with project teams to ensure regulatory alignment with study timelines. May f...

Our client, a start up pharmaceutical company, is currently expanding their team! An exciting opportunity to join a small pharmaceutical company and grow along with them! CNS experience is a plus... this position is located in the company headquarters in Philadelphia, PA. Clinical Trial Manager The Clinical Trial Manager will direct and coordinate the operational and logistical activities necessary for the initiation and completion of clinical trials on time and on budget Primary Responsibilities: • Responsible for managing activities associated...

Our client, a small start-up pharmaceutical company, is currently hiring and growing their team! An exciting opportunity to join a small team and grow along with them! This position will be located at their headquarters in Philadelphia, PA. Clinical Trial Associate The Clinical Trial Associate role will support the Clinical Trial Manager/Operational Team in executing the trial(s) and maintaining effective communication with project teams to ensure alignment with study timelines. Acts as the focus for the project team administration and provid...

Our client, a small start-up pharmaceutical company is currently expanding their team! It's an exciting, fast paced environment with a true team culture! CNS experience is a plus! 50-70% travel as needed. Clinical Research Associate The Clinical Research Associate role will support the Clinical Trial Manager/Operational Team in executing the trial(s) and maintaining effective communication with project teams to ensure alignment with study timelines. The remote role will conduct routine site monitoring visits and participate in site selecti...

Duties & Responsibilities: As part of the local TMF team, the LTRS will: • 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 Sp...

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...

We have a global pharmaceutical client looking to hire additional people for their contracts group to negotiate clinical site agreements and budgets. In addition to the description below, here are some additional items we are looking for: • Strong communication and ability to lead Site Contracts Negotiations for Fully Outsourced work as well as negotiate all types of Site and Investigator Contracts • Clear understanding and experience in managing the development of study budgets for Site Contracts and Budgets negotiatio...

We have a global pharmaceutical client looking to hire additional people for their contracts group to negotiate clinical site agreements and budgets. In addition to the description below, here are some additional items we are looking for: • Strong communication and ability to lead Site Contracts Negotiations for Fully Outsourced work as well as negotiate all types of Site and Investigator Contracts • Clear understanding and experience in managing the development of study budgets for Site Contracts and Budgets negotiatio...

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...

This is a new role for the pharmaceutical company where they are looking for a Manager who can help them to prepare for Inspection Readiness. They are filing several new products with the FDA this year and want to have someone who has had experience preparing for FDA, MHRA and other regulatory authority audits associated with filing new products. They want a Project Manager to help them to organize this but this person has to have had Quality Management experience. Summary/Scope: Lead program teams through the activities of preparing for wor...

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...

The Vice President Clinical Operations will develop and manage the Clinical Operations teams in collaboration with the EVP and GM, of our client's early Phase facility. Provides senior-level leadership and direction for all strategy development, operational planning, and delivery of clinical research trials. Ensures that deliverables are met with high quality and consistent with sponsor contractual agreements. Standardizes and harmonizes divisional processes to ensure consistency and improved efficiency. Responsible and accountable for the effect...

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 Practic...

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 Practic...

Job Description –****this is for the SUPERVISOR ROLE but I ALSO HAVE REGULAR Cytotech roles in Miami FL as well at the same company**** Industry/Function: Anatomic Cytology Laboratory/Clinical Laboratory Title: Cytology Supervisor Job Objectives: The supervisor is responsible for fulfilling the responsibilities of the director as assigned and for monitoring compliance with all applicable regulations of the board and of the Department. Mmaintains and collect Quality Control and Assurance activities data and generate statis...

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 ...

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. Key Responsibilities: 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. Communications: ensures clear written communication to clinical sites and project team members through monitoring repor...

Clinical MEDICAL GENETICIST JOB OPENING IN WESTCHESTER COUNTY NY (30 minutes North of NYC) An exciting opportunity to join an established Comprehensive Medical Genetics practice serving in NYS. We are seeking a full-time tenure track Biochemical/Clinical Geneticist to join our Inherited Metabolic Disease Center and Clinical Genetics Practice. We are a Newborn Screening Referral Center and also have an active Lysosomal Storage Disease Center managing a large cohort of patients. Our physicians are part of a network which have academic appointme...

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

REPORTING RELATIONSHIPS Direct reports: up to 5 DUTIES & ESSENTIAL JOB FUNCTIONS Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff Create and maintain Site Master Validation Plan Review of Batch Records and approve product disposition Review of analytical, stability test methods, protocols & reports Release of raw materials, components, in-process materials and finished products Review and approve investigation reports as appl...

• Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions. • Creation/distribution of regulatory binders & the wet-ink signed documents binder • Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing correct...

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...

Job Title: (TEMP) Assoc. Contracts Manager/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, including contract coordination, routing, exe...

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...

- 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...

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...