Clinical Development Services Agency (CDSA) has therefore been formed as a not-for-profit society to provide supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions. It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases like malaria, tuberculosis and dengue among others.
Post : Senior Research Officer (Zinc Sepsis Study)
Emoluments/ Duration : up to Rs. 75,000 per month, consolidated for 20 months
Location : NCR Biocluster, Faridabad
Job profile
• Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
• Advising and providing training to research team on interpretation of GCP/ethical requirements for quality management.
• Overseeing and/or performing quality functions and executing quality programs (clinical operations, clinical laboratory, data management review)
• Developing quality management plan and ensuring compliance
• Ensure compliance with agreed upon documentation practices
• Identifying areas of deficiency and trends in quality and escalating to appropriate personnel
• Setting up documentation standards and ensure compliance throughout the study span
• Collaborate with clinical and project management team to ensure compliance with quality standards, timelines and appropriate follow-up in areas of deficiency
• Coordinate expert monitoring visit/ audits as per project requirement.
• Educating, training, and mentoring research team in quality improvement methods
• Supervise quality management team to ensure efficient clinical monitoring (site preparedness, study initiation, interim monitoring, close out & termination), archiving, reporting and follow-up for corrective and preventive action.
• Travel up to 50%, as assigned
• Quality assurance through external monitoring Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Qualifications and Experience
Master’s degree in life sciences or biomedical sciences or pharmacy. At least 5 years of demonstrated experience in the area of Quality Control, Quality Assurance and Clinical operations. GCP/ GLP trained personnel will be preferred.
Skills
• Good understanding of needs for project and job responsibilities.
• Extensive knowledge of GCP/GLP and appropriate clinical research regulations and guidelines.
• Ability to develop and implement clinical research monitoring plans, SOPs, database concepts, and formats
• Ability to build effective project teams, ability to motivate others, delegation, drive and timely/ quality decision making
• Operational skills including focus and commitment to quality management and problem solving
• Influencing skills including negotiation and teamwork.
• Effective communication skills to provide timely and accurate information to stakeholders
• Ability to assess non-compliance situations and recognize potential or real wider strategic risk to project, escalates when needed.
• Ability to identify systematic causes of complex quality problems and recommend long-term solutions
• Fair and ethical. Creates a culture that fosters high standard of ethics.
• Basic business computer skills (MS Word, Excel, e-mail)
For More Info Go to Next Page...
Subscribe to Pharmatutor Job Alerts by Email
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified. Interested candidates may please send their current CV with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line Application for the post of “Senior Research Officer” (Zinc Sepsis Study)” to cdsa_admin@thsti.res.in.
5. Only shortlisted candidates will be contacted for further discussion
6. Incomplete applications will stand summarily rejected without assigning any reasons.
7. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based on experience, qualifications, skill set, etc. of the candidates.
8. This position is strictly project-based and hired only for 20 months.
9. All results will be published on our website and all future communications will be only through email
10. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
11. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
12. Canvassing in any form will be a disqualification.
Those who have applied earlier need not apply again.
Note: In case a suitable candidate is not found, the call for application will remain open till suitable candidate is found. As soon as suitable candidate is found, this recruitment notice will be closed on our website.
CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,
Department of Biotechnology, Ministry of Science & Technology, Govt. of India 3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway, Faridabad – 121001 (Haryana)
Recruitment Notice No. CDS/RN/35/2017
See All Ph.D Alerts M.Sc Alerts B.Pharm Alerts M.Pharm Alerts
See All Other Entrances in our Database
.png)
