PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post:
- Senior Quality Specialist/Quality Specialist II {below}
- Research Operations Assistant
- Quality Manager, Process QM
- Clinical Data Analyst II
Post: Senior Quality Specialist/Quality Specialist II
Job Description:
Perform or assist the performing of quality assessments (e.g. quality gates, gap assessment, study file review), feeding back results to the operational teams, line manager and head of the eClinical Process & Training as appropriate.
* In conjunction with PAREXEL Academy, determine local training requirements (e.g. in quality processes, SOPs, software, etc.), and where needed support training delivery to ensure operational staff have appropriate training per the functional curricula to support their role.
* Working with the Process Optimization and Management (POM) group, ensure timely review and maintenance of Controlled Documents (e.g. SOPs and Work Instructions) in accordance with the defined timelines (e.g. every two years).
* Provides support and advice to operational groups on the application of, and adherence to processes and the use of systems.
* Supports eClinical Process & Training and operations staff at audits, client assessments or regulatory inspections, as needed.
* Research and advise on relevant regulatory and industry trends and initiatives to ensure company stays current on GxP compliance issues.
* Ensure knowledge of PAREXELs and third party vendors product lines.
* Facilitate reporting, handling and follow up of Quality Issues.
Experience:
3+ years of EDC database set up related technical experience (InForm, Rave, DataLabs).
SAS programming skills and understanding of CDISC preferred.
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 7th Oct, 2012
Req Number: pare-10016010
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Post: Research Operations Assistant
Job Description:
* Central filing Management (labeling ,transmittal forms and sending to central hub),
* Safety Reports (downloading and Distributing SUSARs to sites as per study guidelines),
* General correspondence (site correspondence cover letters)
* In-house communication (communicating with the team members and assisting CRA with entries in CIMS (IMPACT Harmony or other system), perform QC check when requested.
* Naming conventions and PMED uploading.
* Assigned tasks could include: photocopying, binding, tracking, filing, faxing and also submissions of booking forms, invoices etc
Experience:
From Science Back-ground with Experience in Filing and basic knowledge of computers
Additional Information:
Location: Karnataka - Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 7th Oct, 2012
Req Number: pare-10021486
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Post: Quality Manager, Process QM
Job Description:
In conjunction with operational staff, develop and implement a quality framework (processes and associated training materials). Ensure that the framework is appropriately updated and effective. Provide advice and support to operational staff in functional and cross-functional process application and adherence. Drive the improvement of the quality framework as necessary.
Experience:
Minimum 7 to 10 years of total experience
* Experience in one or more areas of eClinical Process & Training (e.g. process validation) or the functional areas that eClinical Process & Training support.
* Understanding of Clinical technology solutions is preferred.
* Significant experience in a Quality/Regulatory/QA/Training role.
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 7th Oct, 2012
Req Number: pare-10021492
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Post: Clinical Data Analyst II
Job Description:
Key Accountabilities
* Assume the ability to meet the requirements of a CDA I with a high degree of proficiency and autonomy
* Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects
* Train team members on selected tasks
* Prepare Data Cleaning Specification
* Review the Data Validation Specification prepared by the Technical Analyst in GTS
* Develop or provide input to project specific guidelines, e.g. SAE handling.
* Initiate the running of study specific programs
* Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
* Conduct in-house data review,
* Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
* Identify and report protocol violations
* Manual and Patient Profile review, issue queries
* Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
* Track and integrate queries
* Perform clinical coding if appropriate to role within the project team
* If required liaise with 3rd party vendors to clean electronic data
* Ensure all documents coded for submission to central files
* Lock site(s) within EDC system - remove user's data modification privileges
* Interact with site (via mail) as required
* Perform early and final database QC activities
* Update all relevant tracking system on an ongoing basis
* Inform responsible CDA Coordinator of work status regularly
* Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor
Skills
* Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, knowledge of MS-Office products such as Excel, Word
* Sound awareness of all relevant regulations, including GCP
* Ability to successfully work in a (`virtual) team environment
* Client focused approach to work
* If required, knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
* Effectively applies knowledge to provide advice or solutions based on expertise
* Offers support and constructive feedback to project team members
* Seeks opportunities to develop experience and knowledge
* Ability to organize and plan tasks
* Excellent interpersonal, verbal and written communication skills
* Must be able to work independently but seek guidance when necessary, escalating issues as required
* Sense of urgency in completing assigned tasks
* Meticulous attention to detail
* Effective time management in order to meet daily metrics or team objectives
* Shows commitment to and performs consistently high quality work
* Willing and able to travel as required local or international
Experience:
2 to 4 years
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 7th Oct, 2012
Req Number: pare-10016010
Apply Through Recruiters Portal
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