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Serves as Global Program/Brand Team (GPT/GBT) scientific safety leader. Responsible for safety issue management from formation of GPT/GBT through Life Cycle Management (post-approval). Develops and is responsible for key internal safety documents from the formation of the GPT/GBT through Life Cycle Management. Reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other pro­ject-related safety documents, are consistent ...

Our client, a growing Pharmaceutical company in the Lawrenceville area, is seeking a Promotional Review Editor for a 3+ month assignment.  Pay rate is up to $50 an hour plus benefits. Manages the delivery of a full range of editorial services, including medical editing, copy editing, proofreading, and fact verification of pharmaceutical marketing materials, internal and external presentations, and corporate communications, from initial Promotional Review Board (PRB) submission through final approval ...

$5000 Hiring Incentive for qualified candidates! Experienced Clinical Research Associates (CRA) are needed US Nationwide!  Currently we are in urgent need for home-based CRAs with early clinical experience in oncology, respiratory, renal/hepatic, and general med.   If you have at least two years on site monitoring experience, authorized to work in the US for any employer and willing to travel at least 80% - I invite you to read our latest job need by following the link below.   Covance ...

Responsibilities: • Operationally supports and executes the imaging plans outlined in Oncology study protocols including supply of standard language, management of imaging CROs • Preparation of scope of work, imaging charters, and support imaging data transfer and reconciliation. Skills • Familiarity with a broad range of imaging techniques. • Preferred experience in CRO management or CRO environment, and an understanding of Imaging CRO capabilities. • Basic knowledge of clinical ...

Description: The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with client’s processes, GCP/ICH and regulatory requirements. Supports program level activities as assigned. Program/project level responsibilities: • Support the development of operational plans for clinical deliverables, effectively applying principles of design ...

Job Description: Support the operational execution of the clinical study strategies related to biomarker and pharmacokinetic assessments in oncology protocols, in compliance with client’s processes and regulatory requirements and in collaboration with Oncology Clinical Teams. Responsibilities: • Sample tracking for biomarker and pharmacokinetic samples from clinical site to analytical laboratory. • Setting up the laboratory procedures, being the primary point of contact and providing ongoing ...

Responsibilities: • Leads Global Medical Affairs strategy and implementation for specified compound(s). • Acts as medical representative on the Global Brand Team, Global Project Team, and International Clinical Team • Provides clinical leadership and accountable for global medical affairs strategy and life cycle management • Acts as clinical lead for Scientific Communication deliverables and publications (with Scientific Affairs group), brand-related input into therapeutic area and disease area ...

Seeking extensive clinical development experience to help guide discovery strategies and focus pre-clinical resources and efforts most effectively for big pharma research & development activities. Must be a strategic expert and savvy diplomat to work closely with global pharma CEO in the analysis, selection and internal promotion of drug development strategies from evidence-based medicine to sustainable therapeutic solutions. Requires MD-Ph.D, MD, or Ph.D and well rounded research executive with ...

Tasks/Responsibilities: - Manage department’s responsibilities with Trial Master Source- TMS (enter data in to the TMS system, interact with project owners to obtain the information needed for TMS, review that the standards of procedures for safety reporting are followed, respond to TMS queries and prepare data for registration of epi studies) - Support of Research effort to include but not limited to literature searching, literature review, drafting protocols, drafting other associated research ...

Mid-sized CRO seeking RCRA in TX. 4 year degree in life sciences with 2+ year on-site experience. Travel 75-85%. Resumes to [email removed]

  Region to cover: NJ, NY, CT, and PA   CLINICAL RESEARCH ASSOCIATE   Job Key Duties and Responsibilities: This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor: · Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local regulatory requirements, Standard Operating Procedures (SOPs), Standard Guidelines (SGs), Instruction Manuals (IMs), study ...

  · Assists in maintenance, quality control, distribution, and archiving of clinical documents and reports. · Supports development of program specific standards (e.g., agendas, minutes, filing structure, team materials). · Assists with the management and maintenance of team contact lists, calendars, and organizational charts. · Participates in meeting logistics, events and training, where requested by assigned program/compound leader(s), including (but not limited to) o Scheduling ...

  Our client is a Princeton NJ based Consulting Group, focused on independent and ethical review of clinical trials. They are a well-established company comprised of 3 divisions that offer their clients (CROs, healthcare companies and educational institutions) clinical trial review, consulting and research/tech services. Due to growth, they are seeking a Marketing Coordinator who will assist the marketing department in collateral development and sales management activities. Required is 1-2 years of ...

  Order #: 90692 Title of Position:  Sr. Study Manager Company: InVentiv Health Clinical Location: City/State:  Summit, NJ Zip Code:  07901 # of positions: 3 Contract Length:  12 Months    ** LOOKING FOR STUDY MANAGERS OR SR. STUDY MANAGERS The Study Manager is responsible for • Leading one or several cross functional study teams (and/or sub-teams) to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities regulations/guidelines and ...

  Looking for a Regulatory Submissions Manager to work for an amazing client with great benefits!   Please send me your resume for consideration if you are interested! 3-5 years of experience in clinical research, preferable with a CRO. Experience may include CRA or project management experience; Knowledge and experience with Clinical Trial Applications Strong oral and written communication skills. Efficiently manage and successfully execute all aspects of global start-up according to Sponsor ...

Title: Senior Clinical Study Manager Company: Pharmaceutical Company Location: Northern NJ Status: Full-time consulting engagement – 40 hours/week Length: Long term assignment; initial term 1 year Our Client is a global biopharmaceutical company committed to improving the lives of patients worldwide. Their mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of ...

The Senior Scientist conducts advanced PK/PD modeling research utilizing available modeling techniques, with a focus on Oncology compounds. Primarily supports early development and regulatory filing activities by defining the dose-concentration-pharmacological effects relationships of drugs using modeling and simulation methodologies, from data acquired at various development stages. Performs population PK and PK/PD analysis for regulatory submission of various compounds. Uses state-of-the-art ...

 The Study Manager is responsible for: • Leading one or several cross functional study teams (and/or sub-teams) to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities regulations/guidelines and company SOPs/WPs. • Sharing best practices • Contributing to process improvement initiatives Responsibilities may include, but are not limited to, the following: 1. Study Team Leadership - Lead cross-functional study team and/or sub-team, ...

Marketing Manager Our client is a Princeton NJ  based Consulting Group, focused on independent and ethical review of clinical trials. They are a well-established company comprised of 3 divisions that offer their clients (CROs, healthcare companies and educational institutions) clinical trial review, consulting and research/tech services.  Due to growth, they are seeking a Marketing Manager who will report to the Head of Marketing, work with all 3 divisions and  work on a wide breadth of projects, ...

This successful, large pharmaceutical with marketed products and deep pipeline is seeking a highly skilled writer to write high-level regulatory submission documents and manage the submission process.   Excellent Salary, bonus, benefits, and relocation assistance offered for US-based candidates. The Oncology Submission Mgr. will plan and coordinate tasks supporting the timely delivery of high quality documents for sNDAs/Type II Variations or non-complex NDAs/MAAs to Health ...

Our client, a fast paced, growing pharmaceutical company in Central NJ is seeking a Safety Data Specialist for about 6 months.  This position pays up to $47/hour, depending upon experience.    Job Role: • Responsible for collection and processing of spontaneous and clinical trial adverse event and pregnancy reports, which includes data entry and verification of information into the safety database. • Responsible for medical evaluation of relevant reports, which includes narrative generation, ...

Our client is seeking a long term Regulatory Associate for about 2 years with full benefits.  This is an excellent opportunity paying up to $40 an hour. The Regulatory Associate's responsibilities: Labeling • Provide labeling assistance to Regulatory Affairs (RA) Department and assists RA with the preparation and approval of product labeling • Prepare labels using Structured Product Labeling (SPL) authoring tool, Text Verification Tool (TVT), LOLA Workflow • Perform manual proofing of labels in a ...

Looking for a qualified SAS Programmer (home based) Requirements include but are not limited to the following: BA/BS degree in computer science, statistics, biostatistics, mathematics or related field. MA/MS degree is desirable  3-5 years of programming and clinical research or related experience Must have database management, SAS or PL/SQL programming experience Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills ...

Leads Global Medical Affairs strategy and implementation for specified compound(s).Acts as medical representative on the Global Brand Team, Global Project Team, and International Clinical TeamProvides clinical leadership and accountable for global medical affairs strategy and life cycle management Acts as clinical lead for Scientific Communication deliverables and publications (with Scientific Affairs group), brand-related input into therapeutic area and disease area strategies. Provide medical ...

  Job Description:   Support internal customers in the development of outsourcing requirements for Phase I-IV global clinical trials.   Lead and support the qualification and evaluation process for new service providers. Lead the process of Request for Proposal (RFP) development from service provider selection through final contract execution. Manage the contracting process including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work ...

Seeking a Regional CRA in the following states: MN, WI, IA, MO, IL, IN, MI. 2+ years of on-site monitoring experience is required along with a BS/BA degree. Will consider in-house candidates. Any therapeutic area.

Lead the development, implementation, and management of the GCP Quality program compliant with federal regulations (IRB and IEC) and company standards. Candidate must possess at least 5 years experience in the following: *** Developing and executing comprehensive annual audit plans for Clinical Trials. *** Planning, coordinating, and conducting internal and external audits. *** Overseeing Clinical Document Audits *** Writing, reviewing, and updating Standard Operating Procedures *** ...

  We are hiring Statistical Programmers to work onsite in New Jersey area.      Provide statistical programming support and validation and help set specifications of analysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials. Employ standardized programs where applicable. Provide input into planning documents such as protocol, validation plan, and report analysis plan. Provide outputs for clinical study reports, integrated summaries and ...