Opening for Clinical Research Associate at Max Neeman, India.

Position Title: Clinical Research Associate

Location: New Delhi / Mumbai / Pune / Hyderabad / Bengaluru

Qualifications/who should apply: Only MBBS candidates with 1 year of experience as Research Coordinator should apply

Job Description:  To successfully conduct the listed site visits as required by client/study -- Pre Study Site Selection, Site Initiation, Interim Monitoring, Site Close out. Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff. If required train the study site team. To confirm the appropriateness of the site for the study in all aspects and ensure that all documentation required to initiate the study is complete. Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits as directed by the Sponsor/CRO & NMI SOPs. Monitor and track patient enrollment and study progress. Perform site monitoring visits to include review of source document, case report form, ICD, Patient Diary, Investigator Site Binder, other documents as applicable. Ensure the timely accurate and complete collection and submission of study data. Identify, address, and resolve issues and problems as they might occur.
At Study Completion: Ensure collection of all data and remaining study supplies for return to the Sponsor/CRO. Ensure that appropriate study documents are complete and properly filed. Archival with Inventory list of Source documents/ CRFs/ CTM/ Others at site. Prepare the site for possible Regulatory/ FDA inspection.Prepare the site for possible Internal and/or Client Audits. Assist the Sponsor/CRO in problem solving and provide consultation on monitoring and study related activities. To ensure 100% adherence to the monitoring and study plan. Coordinate with Site, Vendors, Client, Regulatory & NMI to maintain best practices through out the course of the study. This position requires 50-70% Travel. To maintain confidentiality of clients/ projects & related information, as applicable. To complete tasks assigned by management as deemed necessary.

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Opening for SAS Programmer at Max Neeman, Delhi, India.

Position Title: SAS Programmer

Location: New Delhi, India

Qualifications/who should apply: The candidate must possess a Masters Degree in Statistics

Should possess minimum 2 yrs experience i.e. functional knowledge. Clinical/ Domain knowledge. Knowledge in Regulatory Guidelines i.e. ICH, GCP Guidelines.

Job Description: Checking the datasets after database locked and Generates Tables, Listings and Graphs as per Statistical Analysis Plan. Supports Validation Team by building external validation checks and supporting to resolve the problems facing due to Pheedit. Batch loading the data as per the requirement of the project. Implementing CDISC standards in programming.

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Opening for Medical Writer at Max Neeman, Delhi, India.

Position Title: Medical Writer

Location: New Delhi, India

Qualifications/who should apply: Minimum Qualification should be MBBS/MD/PhD in any discipline. Exceptional written & oral communication skills is a must. Applicant must have a flair for scientific writing

Experience: Previous experience in medical or scientific writing is desirable. Freshers may apply

Job Description: Developing the clinical study protocol, Clinical Study Report, Regulatory documents and Manuscripts. Review the Case Record Forms (both paper and electronic). Design the Statistical Analysis Plan in conjunction with biostatistics team. Preparation of Investigator’s brochure. Coordination with Biostatistics, Medical Monitoring and Project Management teams.

For More Details visit: http://neeman-medical.com/php/showContent.php?linkid=193&partid=17

Opening for Senior Clinical Data Coordinator at Covance, India.

Post name: Senior Clinical Data Coordinator

Post Code: 28258BR

Place: India

Job Description: Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data

• Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data

• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database

• Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application

• Perform reconciliation of the clinical and safety databases

• Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)

• Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation

• Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved

• Serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.

• Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data

• Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications

• Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions

• Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities

• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality

• Serve as client contact for project meetings and CDM status updates

• Potentially support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.

• Support the training of project staff on project-specific, global, standardized data management processes

• Maintain technical data management competencies via participation in internal and external training seminars

• Review literature and research technologies/procedures for improving global data management practices

• Perform other duties as assigned by management

Qualifications: University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology.

For more details visit: http://www.covancecareers.com/searchJobs.php

Opening for Academic Research Editor, Medicine and Biosciences at Crimson Interactive, Mumbai, Maharashtra, India

Post name: Academic Research Editor, Medicine and Bio-sciences

Place: Mumbai, Maharashtra, India

Job Description: Copy editors always serve the needs of three constituencies:

    * The author(s) -- the person (or people) who wrote or compiled the manuscript

    * The publisher -- the person or company that is paying the cost of producing the printed material

    * The readers -- the people for whom the material is being produced

Key responsibilities: Copy-edit manuscripts to ensure an error-free text, meeting international standards of publication and Double check manuscripts edited by native speakers of English

Subject Areas: Microbiology, Zoology, Botany, Pharmacy, etc.

Qualifications: A Bachelor's/Master's degree

Contact: Akansha Kabre, Phone: +91-22-61935000

Email your resume at: hr@crimsoni.com

For more details visit: http://www.crimsoni.com/opportunities/opn_ae_bioscience.htm

Opening for Quality Analyst, Transcription at Crimson Interactive, Mumbai, Maharashtra, India

Post name: Quality Analyst, Transcription

Job Description: We are looking for Quality Analyst Transcribers with excellent listening skills to transcribe audio related to science and business subjects and also quality check the transcripts. You will be working on varied assignments and projects. The range of assignments will also expose you to vast, diverse and interesting subjects. This position requires the Quality analyst to also handle considerable amount of actual transcription along with QA of transcripts with client-ready quality in all transcripts.

Key responsibilities: Transcribe audio files and ensure that the final transcript meets the quality standards set by Crimson and Ensure timely delivery.

Subject Areas: Media and Entertainment, Business, IT, Medicine, Life Sciences, Engineering.

Qualifications: A Bachelor's/Master's degree

Contact: Jophy Devasia, Phone: +91 22 6193 5000,

Email your resume at: hr@crimsoni.com

Opening for Senior Manager/ Team Leader at Pfizer, India.

Title: Senior Manager/Team Leader

Job ID: 951430

Location: India (Not Specified)

Last Date to Apply For Job: 09/30/2011

Qualification: A minimum of a Master’s degree in Microbiology, Chemistry, Pharmacy or related science.

For more Details visit following link: Click Here