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:
- Clinical Research Associate I { see below }
- RA Manager/Senior Manager
- Clinical Research Associate II
Post: Clinical Research Associate I
Job Description:
The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.
Experience:
' Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
Language Skills
' Competent in written and oral English.
Minimum Work Experience
' Previous work experience (e.g. CR Assistant, nursing, laboratory, data management) would be advisable
Additional Information:
Location: South Korea - Seoul
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 28th July, 2011
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Post: RA Manager/Senior Manager
Job Description:
1. Manage the performance, development and growth of the direct reports.
2. Ensure direct reports meet and aim to exceed their personal goals and objectives by developing appropriate orientation/induction, performance review and development plans for all direct reports.
3. Maintain an agreed level of productivity/billability and staff turnover.
4. Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the staff in an open, balanced and objective manner.
5. Complete the formal review processes (e.g. performance and salary reviews) to Company standards and timescales.
Project Resourcing
1. Participate in and contribute to project bids, including client presentations.
2. Support the feasibility evaluation process.
3. Ensure direct reports meet departmental and project productivity and quality metrics.
4. Appropriately reward and recognize team members.
5. Provide consultation, and facilitate the direct reports to manage the assigned projects to keep project on time and within budget.
6. Arrange resources to support the direct reports timely delivery.
7. Take appropriate action following regular feedback sessions from client¿s technical groups.
Technical Support
1. Support the direct reports to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures.
2. Provide technical support to team members to ensure that they have the required knowledge to fulfill their duties.
3. Address and fulfill individual and departmental training needs.
4. Revise, implement and monitor departmental compliance with SOPs.
5. Implement process improvements, in conjunction with the Management team, in response to client and team feedback and quality audits.
Project Affairs
1. Feasibility study for regulatory aspect
2. Regulatory consultation and compliance review
3. Regulatory information collection
4. Regulatory submission and coordination, including initial submission, supplementary submission, amendment application, and etc.
Experience:
1. Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company; detail oriented; strong written and oral communications skills, as well as excellent interpersonal skills; motivated to work consistently in a fast-paced and rapidly changing environment.
2. Excellent interpersonal, verbal, and written communication skills, (including experience in making presentations at conferences, meetings, training sessions).
3. Team player with outstanding interpersonal, negotiation skills and organizational skills.
4. Demonstrated ability to manage and motivate direct reports.
5. Ability to role model behaviors and ethics in line with PAREXEL Mission, Vision and Values.
Education
A bachelor (or above) degree in life sciences or pharmaceutical background or equivalent.
Language Skills: Fluent English
Minimum Work Experience: Minimum seven years experience in Regulatory Affairs.
Additional Information:
Location: South Korea - Seoul
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 28th July, 2011
APPLY THROUGH RECRUITERS WEBSITE
Subscribe to Pharmatutor Job Alerts by Email
Post: Clinical Research Associate II
Job Description:
The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.
Experience:
' Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
Language Skills
' Competent in written and oral English
Minimum Work Experience
' Substantial monitoring experience in clinical research
Additional Information:
Location: South Korea - Seoul
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 28th July, 2011
APPLY THROUGH RECRUITERS WEBSITE
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