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Multiple vacancies in Parexel as CRA I/III, Clinical Operations Lead, Senior Project Quality Lead, Research Operations Assistant I | JAPAN - Tokyo/Kobe

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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: Clinical Research Associate I

Job Description:
- Complies with clinical leader and is responsible for the following:
- Conducting clinical trials adhering to protocol, SOP and GCP.
- Understanding project timelines and conducting tasks accordingly.
- Collecting quality data which meets client satisfaction, within the timeline and reporting data to clinical leaders.
- Reporting issues in a timely manner and processing necessary actions according to the clinical leader's directions.
- Creating and proposing materials to meet client satisfaction.
- Conduct protocol review meetings, case review meetings, etc.
- Coaching team members appropriately.

Experience:
- Basic knowledge of science, e.g. medical, pharmaceutical, nursing, lab data, etc.
- Has a general understanding of and is able to comply with clinical trials, principals of ethics relevant to clinical trials, GCP and other regulatory requirements.

Additional Information:
Location: JAPAN - Tokyo/Kobe
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 26th July, 2011

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Post: Clinical Research Associate I (New Grad)

Job Description:
- Complies with clinical leader and is responsible for the following:
- Conducting clinical trials adhering to protocol, SOP and GCP.
- Understanding project timelines and conducting tasks accordingly.
- Collecting quality data which meets client satisfaction, within the timeline and reporting data to clinical leaders.
- Reporting issues in a timely manner and processing necessary actions according to the clinical leader's directions.
- Creating and proposing materials to meet client satisfaction.
- Conduct protocol review meetings, case review meetings, etc.
- Coaching team members appropriately.

Experience:
- Basic knowledge of science, e.g. medical, pharmaceutical, nursing, lab data, etc.
- Has a general understanding of and is able to comply with clinical trials, principals of ethics relevant to clinical trials, GCP and other regulatory requirements.

Additional Information:
Location: JAPAN - Tokyo/Kobe
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 26th July, 2011

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Post: Clinical Operations Lead (approved buffer headcount)

Job Description:
- Responsible for leading a clinical team to deliver outcomes which meet timelines and quality and productivity goals based on good communication with the project leader (PL) and client.
- Accountable for the entire clinical operations strategy.
- Act as PL for small projects.
- All rules that require global research operations are applied to all assigned tasks.
- Communicate with client
- Plan and start project
- Execute, manage and evaluate project
- Complete project

Experience:
- 5+ years in a clinical operations role (includes CRA, DM, PM).
- Team leader or sub-team leader or equivalent experience in clinical operations or clinical development, coordinating other departments.
- Clear understanding of cross-functional activities.

Additional Information:
Location: JAPAN - Tokyo/Kobe
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 26th July, 2011

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Post: Clinical Research Associate III

Job Description:
- Supports and complies with clinical leader and is responsible for the following:
- Conducting clinical trials adhering to protocol, SOP and GCP.
- Understanding project timelines and conducting tasks accordingly.
- Collecting quality data which meets client satisfaction, within the timeline and reporting data to clinical leaders.
- Reporting issues in a timely manner and processing necessary actions according to the clinical leader's directions.
- Creating and proposing materials to meet client satisfaction.
- Conduct protocol review meetings, case review meetings, etc.
- Coaching team members appropriately.

Experience:
4+ years in a CRA role.

Additional Information:
Location: JAPAN - Tokyo/Kobe
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 26th July, 2011

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Post: Senior Project Quality Lead

Job Description:
Key Accountabilities:
Standard Quality Interventions
- Implement the standard quality interventions 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 Operations Quality Management in audits and inspections as required.
- Oversee the collection and reporting of project quality metrics.

Risk-Based Quality Interventions
- 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 interventions in areas of risk.

Other Accountabilities
- Mentor Project Quality Leads I and II, as assigned.
- Work closely with other PQLs assigned to the client.
- 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.

Skills:
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- Substantial clinical trials experience
- Leadership and project management skills
- Ability to handle complex projects
- 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 as needed

Experience:
Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).

Additional Information:
Location: JAPAN - Tokyo/Kobe
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality
End Date: 26th July, 2011

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Post: Research Operations Assistant I

Job Description:
Responsible for complying with and supporting clinical leader.
- Conduct clinical trial adhering to protocol, SOP and GCP.
- Collect quality data which meets client satisfaction within timeline and reporting data to clinical leaders.
- Report issues in a timely manner and process necessary actions according to clinical leaders' directions.
- Create materials to meet client satisfaction.

Experience:
- Basic knowledge of science, e.g. medical, pharmaceutical, nursing, lab data, etc.
- Has a general understanding of and is able to comply with clinical trials, principals of ethics relevant to clinical trials, GCP and other regulatory requirements.

Additional Information:
Location: JAPAN - Tokyo/Kobe
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 26th July, 2011

APPLY THROUGH RECRUITERS WEBSITE

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