better Biotech Pharma Job at Business Services

AE CASE MANAGEMENT Receipt Execute receipt of Drug Safety phone calls and complete telephone AE form Create phone call communication logs in ARISg Triage Support the triage of cases conducted by Snr Specialist as needed Assessment - Complex Case Support the assessment of complex cases conducted by Snr Specialist as needed Assessment - Non-Complex Case Execute QC on key fields of serious cases Create key fields updates in ARISg based on QC, as needed Execute case assessment (review events, determine labeledness

My client a medium size biopharmaceutical company is looking for an In House CRA. The CRA is assist in the preparation for an NDA submission. This position involves the ability to recognize and locate study related ICH essential documents within the company's document management system and in official paper files. My client is looking for someone who is familiar with data management and or statistical documents and data would be a plus. Knowledgeable with FDA/GCP/ICH guidelines and phase 1-3 clinical trial

This position is NonExempt. Hours over 40 will be paid at Time and a Half. Experienced data management professional who is responsible for all activities relating to over 20 studies over the course of 1 year. The primary goals are to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams. Also includes Case Report Forms; initiating the purchase of CRFs, diaries, and related documents from clinical protocols, preparing the study database

Responsibilities: Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal

Responsibilities: Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal

Responsibilities: Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal

Our well-respected Pharmaceutical Client in San Diego is looking for a consultant Drug Safety Specialist. - Performs literature reviews from article titles and/or abstract searches for marketed products - Assesses abstracts, orders and assesses articles and reporting of literature content as appropriate - Performs initial triage of drug safety and/or product complaints - Confirms, processes, and evaluates adverse events (AE)/serious adverse events (SAE) for regulatory submission - Ensures

Pierce Technology Corporation has an exciting contract to hire opportunity for a Clinical Project Manager Healthcare and IT in NY City. POSITION SUMMARY: We are currently looking for Clinical Project Manager who has experience with developing project plans. Assist in project management of 3rd party content vendors and internal product development resources for multiple on-going content initiatives. Working closely with internal product management, product development, quality assurance, professional

This position is NonExempt. Hours over 40 will be paid at Time and a Half. Experienced data management professional who is responsible for all activities relating to over 20 studies over the course of 1 year. The primary goals are to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams. Also includes Case Report Forms; initiating the purchase of CRFs, diaries, and related documents from clinical protocols, preparing the study database

You offer your unique skills and experiences. And Manpower Professional offers something unique for you. We're the place for talented individuals who want to do things differently, get ahead and establish a lifelong career. In this position, you'll have the opportunity to: Assist in preparing Clinical Study Agreements for clinical sites. Maintain and update databases. Some data entry and working with templates. Medical Writing Provide operational support for delivery of assigned studies or programs on time

This position is NonExempt. Hours over 40 will be paid at Time and a Half. Experienced data management professional who is responsible for all activities relating to over 20 studies over the course of 1 year. The primary goals are to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams. Also includes Case Report Forms; initiating the purchase of CRFs, diaries, and related documents from clinical protocols, preparing the study database

AE CASE MANAGEMENT Receipt Execute receipt of Drug Safety phone calls and complete telephone AE form Create phone call communication logs in ARISg Triage Support the triage of cases conducted by Snr Specialist as needed Assessment - Complex Case Support the assessment of complex cases conducted by Snr Specialist as needed Assessment - Non-Complex Case Execute QC on key fields of serious cases Create key fields updates in ARISg based on QC, as needed Execute case assessment (review events, determine labeledness

Clinical Project Manager The Nations top clinical research company is looking for Project Manager. A degree in Life Sciences as well as a strong background in finance is essential to this critical role. A qualified Project manager will have 5+ years of experience with CRO s where their responsibilities include the creation and adherence to strict, clinical SOPs. The Project Manager will also need to collaborate in proposal preparation, budget development and contract negations. Strong interpersonal skills

Clinical Resarch Recruiter Looking for an Experienced Recruiter with Clinical Research Background. Clinical Research background Mandatory. Candidate needs to have a recruiting background and the ability to build long term relationships. Looking for great organizational skills and geographical close to Newton, Ma. Salary ranges from 40-50K with a competitive commission package. Apply ASAP. Send resumes directly to david.levin@roberthalf.com or call 617-951-4000. Additional Information Location: Newton, MA Job

Our client is a leading global provider of innovative medical devices for the treatment of peripheral vascular disease. They develop, manufacture and market disposable and implantable vascular devices to address the needs of vascular surgeons and interventionalists. The Company is listed on NASDAQ. The Clinical Project Manager will report directly to the Director of Clinical Affairs and have the following primary responsibilities: Responsible for CRF design, modification/creation of ICF, Investigator brochures

Our client is a leading global provider of innovative medical devices for the treatment of peripheral vascular disease. They develop, manufacture and market disposable and implantable vascular devices to address the needs of vascular surgeons and interventionalists. The Company is listed on NASDAQ. Summary Monitors clinical studies for sponsor company at participating study sites by performing the following duties. Essential Duties and Responsibilities include the following. Other duties may be assigned.

Req ID 10053BR Job Title Lead BioSecurity/BioTechnologist Location VA: McLean Profession Information Technology Department Code E551 Purpose MITRE is applying computer science, modeling & simulation, public health, and molecular and cell biology expertise to the development of information management and data analysis systems that increase bioterrorism preparedness and response within the DoD and across a number of other government agencies. Key Functions Provide leadership to a growing biotechnology group working

Take your career to the next level! One of the world's most valued pharmaceutical companies is in search of an exceptional Regional Clinical Research Associate in Detroit, MI. As the successful candidate, you have the opportunity to be regionally based and responsible for the monitoring of clinical trial activities in compliance with FDA regulation, ICH/GCP guidelines, and company SOPs - all in support of new drug applications. This position offers a full benefit package!

Kforce is seeking a talented Senior Manager of Biostatistics for a Thousand Oaks client. Functions: Provide statistical input in the design, analysis, interpretation, and reporting of results for MA study protocols Be a representative of the biostatistical function on a Medical Affairs Team Participate in protocol development (for clinical trials and non-intervential studies) Be responsible for development of the statistical analysis plan and statistical reports Review study related documents such

We are seeking a Clinical Research Associate (CRA) for a position in New Providence, NJ. Under the direction of the Study Specialist, primary duties of the CRA include: Perform implementation of monitoring and recruitment plans Design CRF completion guidelines Identify investigators and management of investigator sites Provide assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally Interact with investigators, study site personnel

A Clinical Data Manager is currently being sought for a contract position in Ridgefield Park, NJ. The Clinical Data Manager is responsible for the quality and timeliness of all data management activities for a study by preparing validation plans and chairing validation meetings. The position will prepare material for presenting at investigator meetings and will identify errors and inconsistencies in CRF data and ensure their resolution. The CDM will be responsible for study startup documents, data cleaning,

Clinical Programming (CP) writes programs to produce reports used in clinical data review. They work in concert with study implementation teams to define and develop listings to assist the monitoring of clinical trials. CP staff also use BRIO, OCL, UNIX, and other tools to support CDM and other cross-departmental initiatives. Senior Clinical Programmer Analyst Job Responsibilities: Applies advanced level programming techniques and leadership to the design, development, implementation, and maintenance of

A Clinical Data Manager is currently being sought for a contract position in South San Francisco, CA. The Clinical Data Manager is responsible for the quality and timeliness of all data management activities for a study by preparing validation plans and chairing validation meetings. The position will prepare material for presenting at investigator meetings and will identify errors and inconsistencies in CRF data and ensure their resolution. The CDM will be responsible for study startup documents, data cleaning

Our client is seeking a Senior Biostatistician. The Senior Biostatistician works with the senior biostatistics staff and clinical monitors on clinical development plans, the design and conduct of clinical studies, the evaluation, interpretation, and reporting of study results, and regulatory submissions to the FDA. As part of a development assessment team, this person collaborates in the preparation and review of the clinical development plan. For assigned clinical development projects, this person provides

Kforce is currently seeking a Clinical Data Coordinator (CDC) for a position in Rockville, MD. The CDC will be responsible for assisting with the day-to-day data management tasks conducted for assigned projects. The CDC provides input into the development of Project Specific CRFs, departmental SOPs, and process improvements, and may participate the training of other CDCs. The incumbent will also participate in study set-up and lock, annotating CRFs, query management, and discrepancy management. Additionally

We are seeking a Clinical Research Associate (CRA) for a position in Nutley, NJ. Under the direction of the Study Specialist, primary duties of the CRA include: Perform implementation of monitoring and recruitment plans Design CRF completion guidelines Identify investigators and management of investigator sites Provide assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally Interact with investigators, study site personnel, and

Kforce is seeking a talented individual to fill the role of Associate Director of Biostatistics for one of it's prestigious clients. This Biostatistician will provide technical leadership to the Department, partner with clinicians to design efficient trials, contribute to the development of clinical and regulatory strategies, and conduct clinical, PK/PD, and biomarker data analyses. Functions: Design efficient clinical trials Contribute to the development of clinical and regulatory strategies Serve as

Take your career to the next level! One of the world's most valued pharmaceutical companies is in search of an exceptional Regional Clinical Research Associate in San Francisco, CA. As the successful candidate, you have the opportunity to be regionally based and responsible for the monitoring of clinical trial activities in compliance with FDA regulation, ICH/GCP guidelines, and company SOPs - all in support of new drug applications. This position offers a full benefit package!

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! You will be supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and our client's company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication

We are seeking a Clinical Research Associate (CRA) for a position in Princeton, NJ. Under the direction of the Study Specialist, primary duties of the CRA include: Perform implementation of monitoring and recruitment plans Design CRF completion guidelines Identify investigators and management of investigator sites Provide assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally Interact with investigators, study site personnel, and

We are seeking a Clinical Research Associate (CRA) for a position in Cherry Hill, NJ. Under the direction of the Study Specialist, primary duties of the CRA include: Perform implementation of monitoring and recruitment plans Design CRF completion guidelines Identify investigators and management of investigator sites Provide assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally Interact with investigators, study site personnel

The Clinical Trial Manager is accountable for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities. Job duties and responsibilities include: Perform job duties with minimal guidance from the Clinical Program Manager Serve as primary contact for functional area representatives in managing protocol execution Ensure accuracy and timeliness of vendor and site payments Oversee forecasting of clinical/non-clinical supplies

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication

A Clinical Data Manager is currently being sought for a contract position in Exton, PA. The Clinical Data Manager is responsible for the quality and timeliness of all data management activities for a study by preparing validation plans and chairing validation meetings. The position will prepare material for presenting at investigator meetings and will identify errors and inconsistencies in CRF data and ensure their resolution. The CDM will be responsible for study startup documents, data cleaning, query tracking

We are seeking a Clinical Research Associate (CRA) for a position in Wilmington, DE. Under the direction of the Study Specialist, primary duties of the CRA include: Perform implementation of monitoring and recruitment plans Design CRF completion guidelines Identify investigators and management of investigator sites Provide assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally Interact with investigators, study site personnel

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication

Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication

Description of Functions: Manages resources and project priorities and timelines for assigned clinical trials Participates in strategy development and contingency planning Designs, documents, tests, and implements complex statistical analysis methods in collaboration with Clinical Affairs and other Departments Works with the Clinical Affairs Project Team on CRF design to ensure data meets analysis needs Works with the Database Development Team to ensure that database design meets analysis needs *

We are seeking a Clinical Research Associate (CRA) for a position in Wilmington, DE. Under the direction of the Study Specialist, primary duties of the CRA include: - Perform implementation of monitoring and recruitment plans - Design CRF completion guidelines - Identify investigators and management of investigator sites - Provide assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally - Interact with investigators, study site personnel

Sheridan Clinical Research, Inc. has an opportunity for a Clinical Research Project Manager based out of Sunrise, FL. Qualified candidate reports to Director of Clinical Research and will manage our clinical trial projects and research sites. Proven Clinical Research Administration and Management skills with a track record are necessary. The position requires effective organization, communication, and motivational skills. The Project Manager functions to supervise physicians, sites, and other members of

Responsibilities: Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal

Responsibilities: Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal

Responsibilities: Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal

Responsibilities: We are seeking a Clinical Research Associate (CRA) for a position in Cherry Hill, NJ. Under the direction of the Study Specialist, primary duties of the CRA include: - Perform implementation of monitoring and recruitment plans - Design CRF completion guidelines - Identify investigators and management of investigator sites - Provide assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally - Interact with investigators

Responsibilities: We are seeking a Clinical Research Associate (CRA) for a position in Princeton, NJ. Under the direction of the Study Specialist, primary duties of the CRA include: - Perform implementation of monitoring and recruitment plans - Design CRF completion guidelines - Identify investigators and management of investigator sites - Provide assistance to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally - Interact with investigators, study