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Career in PAREXEL | Opening for Clinical Data Analyst I, Project Quality Lead II, Quality Specialist, Clinical Data Analyst II, Drug Safety Specialist - pharmacovigilance

 

Clinical courses

PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

POSTS:

  • Clinical Data Analyst I {below}

Post: Clinical Data Analyst I

Job Description:
- 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
- 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 regular interaction / supervision by Manager or assigned mentor
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedure
- Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims


Candidate profile:
- Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, MS-Office products such as Excel, Word.
- Demonstrate a 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)
- Solid interpersonal, verbal and written communication skills
- 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

Experience:
- 1 to 2 Years relevant Clinical Data Mangement experience
- Educated to minimum of Graduation in LifeSciences or equivalent experience
- Fluent in English


Additional Information:
Location: India - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 31st March, 2012

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Post: Project Quality Lead II

Job Description:
Provide quality oversight to project team management throughout the project. Specifically responsible for standard and risk-based quality evaluations including: review of key project documentation, consultation, CAPA support, audit and inspection support, and collection and reporting of project quality metrics. Focused on data operations quality evaluations with expansion to other functional areas.
- Implement the standard quality evaluations for assigned projects, verifying compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements.
- Review key project documentation and provide feedback to the project team.
- Actively participate in key internal project team meetings and facilitate quality discussions during these meetings, as appropriate.
- Lead quality-focused meetings and/or discussions, as appropriate.
- Provide quality consultation support to project teams.
- Provide CAPA support to project teams including classification of issues, consultation on appropriateness of corrective and preventive actions and tracking of CAPAs through resolution.
- Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections. Review and provide feedback on project related audit/inspection responses generated by project team members prior to finalization. Represent Quality Management in audits and inspections as required.
- Oversee the collection and reporting of project quality metrics.
- Identify and evaluate potential risks, in collaboration with project team management and other relevant parties (e.g., Project Management Quality Management, operational and functional staff). Together with these parties, determine appropriate mitigation measures.
- Implement additional quality evaluations in areas of risk.
- Identify process improvement opportunities and champion their implementation as assigned.
- Participate in SOP and process development as assigned.
- Maintain an understanding of PAREXEL standard operating procedures that are relevant to the assigned project(s) and of relevant regulations and guidelines.
- Perform other quality related tasks as assigned.

Candidate profile:
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
- Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
- IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
- Ability to travel
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
- English proficiency (written and oral English)
- Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field). Data operations experience and expertise required.

Additional Information:
Location: India - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 31st March, 2012

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Post: Quality Specialist

Job Description:
- 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

Candidate profile:
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:
Experience
- 2 to 4 years of Minimum Relevant Clinical Data Management Experience
- Minimum of Graduation in Life Sciences of equivalent experience
- Fluent in English

Additional Information:
Location: India - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 31st March, 2012

Apply Through Recruiters Portal

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Post: Clinical Data Analyst II

Job Description:
Provide quality oversight to project team management throughout the project. Specifically responsible for standard and risk-based quality evaluations including: review of key project documentation, consultation, CAPA support, audit and inspection support, and collection and reporting of project quality metrics. Focused on data operations quality evaluations with expansion to other functional areas.
- Implement the standard quality evaluations for assigned projects, verifying compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements.
- Review key project documentation and provide feedback to the project team.
- Actively participate in key internal project team meetings and facilitate quality discussions during these meetings, as appropriate.
- Lead quality-focused meetings and/or discussions, as appropriate.
- Provide quality consultation support to project teams.
- Provide CAPA support to project teams including classification of issues, consultation on appropriateness of corrective and preventive actions and tracking of CAPAs through resolution.
- Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections. Review and provide feedback on project related audit/inspection responses generated by project team members prior to finalization. Represent Quality Management in audits and inspections as required.
- Oversee the collection and reporting of project quality metrics.
- Identify and evaluate potential risks, in collaboration with project team management and other relevant parties (e.g., Project Management Quality Management, operational and functional staff). Together with these parties, determine appropriate mitigation measures.
- Implement additional quality evaluations in areas of risk.
- Identify process improvement opportunities and champion their implementation as assigned.
- Participate in SOP and process development as assigned.
- Maintain an understanding of PAREXEL standard operating procedures that are relevant to the assigned project(s) and of relevant regulations and guidelines.
- Perform other quality related tasks as assigned.

Candidate profile:
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
- Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
- IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
- Ability to travel
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
- English proficiency (written and oral English)
- Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field). Data operations experience and expertise required.

Additional Information:
Location: India - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 31st March, 2012

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Post: Drug Safety Specialist - pharmacovigilance

Job Description:
Essential Function
The Drug Safety Specialist will provide technical and process-related expertise to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Key Accountabilities
- Develop project specific safety reporting procedures and workflows and provide guidance to the team on the procedures
- Develop project specific safety database customization and data entry guidelines
- Triage of incoming reports for completeness, legibility and validity
- Initial data entry of case reports into safety database / tracking system
- Assessment of case reports for seriousness, causality and expectedness
- Requesting follow-up i.e. written, telephone
- Adverse event (AE) and drug coding
- Writing case narratives
- Case reconciliation, coordinating activities with Data Management personnel
- Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports etc
- Quality control of case reports, line listings and tabulations
- Maintaining local drug safety reporting requirements
- Regulatory authority reporting (electronic and hard copy)
- Literature reviews
- Ad hoc requests / queries
- Provide drug safety and project specific training
- Quality Assurance activities such as preparing for audits, development of templates, checklists and guidelines
- Create and maintain project specific working files, case report files and project central files
- Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects.
- Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as:
- drafting, writing and editing of protocols and CRFs
- collection and review of endpoint packages
- review and follow-up laboratory alerts
- review and follow-up patient eligibility for inclusion /
exclusion in clinical trials
- review and follow-up protocol violations
- preparing relevant procedures covering the above medical
monitoring activities
- review study specific Model ICFs according ICH/GCP criteria
- Act as the Medical Monitoring Representative in project teams, as appropriate
- Participate in client meetings / investigator meetings/ project specific training sessions
- Delegate work as appropriate to Drug Safety Associates and Drug Safety Assistants

Candidate profile:
- Sound knowledge of drug safety and the drug development process
- Knowledge of and ability to interpret and apply global safety regulations.
- Experience in data analysis and evaluation of safety data
- Demonstrated competence in processing, evaluating and reporting safety information in compliance with the regulations
- Good presentation skills
- Excellent interpersonal skills
- Excellent verbal / written communication skills
- Good time management skills
- Team player
- Client focused approach to work
- Experience with computer applications including database management and pharmacovigilance related computing systems

Experience
- Drug safety knowledge and experience of safety database
- Experience in working in drug development and/or healthcare environment

Education (one of:)
- Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification
- Associates/diploma degree in any of the above with appropriate work experience

Language Skills
- Fluent English

Additional Information:
Location: India - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Pharmacovigilance
End Date: 31st March, 2012

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