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Career Opportunity in Parexel | Join as Quality Specialist, Clinical Data Analyst I (Coder), Clinical Database Programmer II, Quality Specialist II

 

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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.

POSTS:

Post: Quality Specialist

Job Description:
Provide support to the TQM team and perform TQM activities on assigned projects, commensurate with experience and / or project role. General responsibilities include maintaining system register entries, creating test data, performing testing, creating documentation to PAREXEL standards as required. Work to the appropriate corporate standards of quality and efficiency, WSOPs/Guidelines, ICH-GCP and/or other international regulations as applicable.


Key Accountabilities
- Promote a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to others in an open, balanced and objective manner
- Deliver best value and high quality service for the benefit of PAREXEL and ensure compliance with PAREXEL Quality standards, Controlled Documents and appropriate regulations
- Support the implementation of functional, or cross-functional, systems and tools in line with PAREXEL Operations and PAREXEL Quality Management strategies
- Support development and implementation of project plan, as required, for assigned projects
- Provide support to the CSV lead on assigned projects
- Provide support to trainers in technical aspects
- Provide support during regulatory inspections, audits and/or client audits
- Provide support to the Designated Responsible Individual (DRI) for assigned systems
- Maintain the System Register entries for all systems
- Maintain VSG documentation system
- Create and maintain the web site and associated enhancements for VSG/Software
- Provide support in the creation of test scripts
- Create and enter test data for CSV/Software activities
- Execute process and system testing as part of CSV activities
- Prepare, review and maintain relevant Controlled Documents
- Keep abreast of regulatory requirements and technical innovations
- Participate and contribute in project team and departmental meetings
- Document and implement internal customer requests and/or team decisions
- Perform project tasks in accordance with project timelines and to the required quality standards
- Utilize appropriate TIME codes as they relate to a particular task
- Keep manager(s) informed about work progress and any issues to avoid surprises. Requires significant interaction / supervision by Manager or assigned mentor
- Perform all tasks as reasonably requested

Skills
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload
- Willingness to work in a matrix environment and to value the importance of teamwork
- Be able to function as part of a `virtual, global team as required
- Meticulous attention to detail
- Basic computer skills including familiarity with MS Office
- Ability to organize and plan tasks
- Ability to travel as needed for the position and to support other offices
- Effective time management in order to meet team objectives
- Commitment to project and team goals
- Ability to follow instructions
- Must be able to work independently but seek guidance when necessary
- Exhibits a sense of urgency about solving problems and completing work
- Shows commitment to and performs consistently high quality work
- Seeks opportunities to develop experience and knowledge


Experience:
Education
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Language Skills
- Excellent English written and oral communication skills
Minimum Work Experience
- Relevant experience preferred if no Bachelor's degree

Additional Information:
Location: India - Andhra pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 20th Jan, 2012

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Post: Clinical Data Analyst I (Coder)

Job Description:
- Perform clinical coding within the project team (Experience of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
- Take responsibility for specific tasks on projects
- 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
- 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

Experience:
Skills
- Preferred knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
- 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
- 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

Education & Experience
- Educated to minimum of Graduation in Lifescience or equivalent - experience
- 1 year of relevant Clincial Data Coding
- Excellent English Communication skills

Additional Information:
Location: India - Andhra pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Data management
End Date: 20th Jan, 2012

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Post: Clinical Database Programmer II

Job Description:
The Clinical Database Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to clinical systems and/or the applications/systems within eClinical technologies. There are two specific functions that
may be filled by the Clinical Database Programmer II, dependent on skill sets and experience; Clinical Systems and Support Programmer and Database Programmer.

Key Accountabilities
- Deliver best value and high quality service.
- Ensure quality control (QC) on all process and technical activities related to:
- trial set-up and maintenance, and/or
- implementation of system applications and upgrades/changes
to those applications as required
- are performed in accordance with corporate quality
standards, SOPs / Guidelines / Work Instructions , ICH-GCP
and/or other local or international regulatory requirements.
- Check own work in an ongoing way to ensure first-time quality.
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work
Instructions to ensure traceability and regulatory compliance.
- Proactively participate in quality improvement initiatives.
- Ensure compliance with SOPs/Guidelines/Work Instructions, ICH-GCP and any other applicable local or international regulations and participate in internal/external audits and regulatory
inspections as required.
- Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS and other programming language usage and processes within the GRO, biostatistics, and medical areas.
- Provide relevant training and mentorship to staff and project teams as appropriate.
- Assist project teams in the resolution of problems encountered in the conduct of their daily work.

Database Programmer
- Create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC
compliant format as required, including the annotation of CRFs where applicable.
- Create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
- Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
- Perform small to medium size ad-hoc programming tasks.

Experience:
- Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
- Knowledge of the programming and reporting process within GRO.
- Knowledge of SOPs/Guidelines/WorkInstructions/ System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven
practical application.
- Demonstrate ability to learn new systems and function in an evolving technical environment.
- Attention to detail.
- Ability to work together with a team (including international teams as required) as well as independently.
- Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
- Business/Operational skills that include customer focus, commitment to quality management and problem solving.
- Work effectively in a quality-focused environment.

Education
Graduate or equivalent in a relevant discipline is preferred or equivalent work experience.

Language Skills
- Very good English written and oral communication skills.

Minimum Work Experience
- 3 to 4 years of SAS/RAVE experience in ecrf build, editchecks build, Transfer programming, offline listings and other SAS related tasks. SDTM experience is must
- Experience working with at least one system used within the Clinical Trial process(e.g., SAS,CDMS, EDC (Inform,RAVE,DataLabs), CTMS, Medical Safety Reporting)

Additional Information:
Location: India - Andhra pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Data management
End Date: 20th Jan, 2012

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Post: Quality Specialist II

Job Description:
Provide technical expertise, resource and mentoring for the implementation, infrastructure qualification, computer systems validation and ongoing support & maintenance activities related to IT Infrastructure and systems used by PAREXEL staff in daily business and or clinical trial activities. General responsibilities include process improvement projects for IT , providing quality management support pertaining to technical activities, and representing PAREXEL systems in audit/inspections. Work to the appropriate corporate standards of quality and efficiency, WSOPs/Guidelines, ICH-GCP and/or other international regulations as applicable.

Key Accountabilities
- Promote a positive, results orientated work environment, build partnerships and model teamwork, communicate to others in an open, balanced and objective manner
- Deliver best value and high quality service for the benefit of PAREXEL and ensure compliance with PAREXEL Quality standards, Controlled Documents and appropriate regulations
- Lead the qualification of functional, or cross-functional, systems and tools in line with IT, PAREXEL Operations and PAREXEL Quality Management strategies
- Participate in large scale or complex IT infrastructure& systems implementation teams and or consult teams during large scale design projects
- Support development and implementation of project plan, as required, for assigned projects
- Document user requirements and provide input into design specifications to ensure these are met
- Act as Designated Responsible Individual (DRI) for assigned IT infrastructures & systems
- Prepare, review and maintain relevant Controlled Documents e.g. SOPs and Work Instructions
- Create and Maintain qualification and validation plans as well as reports for IT infrastructures and computerized systems
- Support monitoring programs that aim at continuously evaluating and improving IT service quality
- Perform Infrastructure Assessments i.e. evaluation of IT infrastructures & support processes
- Lead and Perform Assessments of 3rd party IT providers or IT outsourcing partners
- Train IT staff in related SOP especially those design and managed by TQM
- Perform hand-off of tasks to relevant groups such as Process and Training, as required
- Keep abreast of regulatory requirements and represent PAREXEL systems at regulatory inspections, audits and/or client audits
- Represent PAREXEL in IT infrastructure& system improvement initiatives
- Initiate escalation of significant quality issues to Management as required

Skills
- Excellent interpersonal, verbal and written communication skills, decision making skills, business understanding, and strong organizational skills
- Personal qualities that include the ability to gain trust and confidence with a variety of clients within PAREXEL
- Ability to work in an action-oriented, fast-paced and rapidly changing environment
- Ability to prioritize workload and manage multiple and varied tasks with enthusiasm
- Client-focused approach to work
- Exhibits a sense of urgency about solving problems and completing work
- Culturally aware and ability to think and work globally
- Ability to lead a `virtual, global team as required
- Actively seeks opportunities to develop experience and knowledge
- Ability to travel as needed for the position and to support other offices

Experience:
- Adequate experience of IT infrastructures such as server operating systems, networking, middleware platforms
- Experience in the development and management of policies and procedures
- Preferably understanding and experience in good practices and standards like ITIL, CoBIT, ISO 9002
- Preferably experience in performing internal or external assessments

Education
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

Language Skills
- Excellent English written and oral communication skills

Additional Information:
Location: India - Andhra pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 20th Jan, 2012

APPLY THROUGH RECRUITERS WEBSITE

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