Life Science Job at THSTI-CDSA – Apply Online
Life Science Job at THSTI-CDSA – Apply Online. MSc Govt life sciences jobs at CDSA-THSTI with high pay. CDSA Life Sciences Job. For more details on the government high paying life sciences Consultant (Project Manager) TB-Vaccine (POD) opportunity, check out all of the details below:
This Job Expires In :
Govt Job Details
Recruitment Notice No. CDS/RN/7/2021
Position: Consultant (Project Manager) TB-Vaccine (POD)
No. of Posts: 01
Name of the Project: (A Phase III, Multicenter, Randomized, Double-blind, Three arm
Placebo controlled Trial to Evaluate the Efficacy and Safety of two vaccines in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly Diagnosed Sputum Positive
Pulmonary TB Patients funded by ICMR in Six States of India)
Location: CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad
Job Profile:
Project Manager (PM) is responsible for the overall coordination and management of clinical trial from initiation through closeout activities. PM oversees the technical and operational
aspects of the project. PM collaborates and works closely with other departmental leads (Data management, safety management, and quality management), sponsor and DCPM to
identify and evaluate risks and issues on the
Oversees project management and quality management processes and provides guidance and support to project teams to meet quality standards.
- Ensure that the assigned trial is conducted in accordance with trial protocols, GCP guidelines, GCLP guidelines and applicable regulatory requirements.
- Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements.
- Proactively identify the project risks and assist in providing training to trial staff in good clinical and documentation practices.
- Maintain GCP and GCLP compliant processes which control the quality of work at the trial site
- Oversee and assess trial trends
- Overseeing and/or performing quality functions and executing quality programs (project management, clinical operations, clinical laboratory, data management review)
- Collaborate with clinical and other stakeholders to ensure compliance with quality standards, timelines and appropriate follow-up in areas of deficiency
- Coordinate expert monitoring visit/ audits as per project requirement.
- Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
- Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions)
- Manage a team of study monitors
- Guide and mentor the study monitors for project deliverables
- Perform project management tasks including the management of project meeting organization for the investigator meetings, steering committee meetings etc.
- Work with data management to ensure that the data queries are addressed and data is cleaned as per the data management plan.
How to Apply for Govt Job:
- All educational technical and professional qualification ought to be in a recognized Board/ University and fulltime.
- The experience requirement given should be the experience obtained after obtaining the minimum educational qualifications necessary for the post.
- Persons working in Govt. Or Public Sector project should produce”No Objection Certificate” in the time of Interview.
- The qualification, experience and other requirements for your post may be relaxed at the discretion of the controlling authority if candidates are well qualified.
- Only shortlisted candidates will be contacted for an interview.
- Incomplete applications will stand summarily rejected without assigning any
reasons - The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is the maximum and can be lesser based on candidate’s experience, qualifications, skill set, etc. A 10% annual increase in salary is based on the performance
- This position is strictly project-based.
- Internal CDSA Candidate will be provided NoC, only if they have completed a minimum of 1 year of services in their current position, failing which the Screening Committee has the authority to reject the application without giving any reason. Without submission of NoC, the application will be withheld.
- All results will be published on our website and all future communications will be only through email
- Candidates (Including SC/ST and other backward classes) are not entitled to the travel reimbursement or any other reimbursement for attending the interview.
- This position will be placed in the CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
- Canvassing in any form will be a disqualification.
- Submission of application will be thru online mode only otherwise it will get rejected or ignored.
Process for completing the online application for Govt Job:
a. Before filling up the online application, keep these documents handy:
i) A soft copy of your passport size photograph and signature. (only jpeg/jpg format, file size 50 kb max )
ii) A comprehensive CV (PDF format only, file size 1 MB max ) containing details of qualification, positions held, professional experience/distinctions etc.
a. Candidates are asked to utilize Google Chrome/ Microsoft Edge Browser for best results in submission of online application.
b. Once an online application is submitted, no correction/ modification is possible.
c. In the event of difficulty in filling the online form, please send an email to [email protected].
d) Those who have applied once need not apply again.
e) Only technical queries will be resolved (if any), other than technical will not be entertained.
e. On successful submission of your application, an auto-generated email containing a reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence
Note: In case a suitable candidate is not found, the call for application will remain open till a suitable candidate is found. As soon as a suitable candidate is found, this recruitment notice will be closed on our website.
The last date of receipt of application is 02nd March 2021.
Qualifications and Experience & Desirable for Govt Job:
- Master’s degree in life sciences or biomedical sciences or pharmacy or Public Health OR
- MBBS/ BDS/ BHMS/ BAMS/ BPT OR
- Masters in Clinical Research.
Essential experience:
- At least 4 years of demonstrated experience in the area of clinical research project management and/ or clinical operations and/ or clinical research monitoring, lab monitoring, vendor management and team management.
- GCP trained and experience in handling clinical trials will be preferred.
Skills:
- Good understanding of needs for project and job responsibilities.
- Extensive knowledge of GCP, clinical trials and appropriate regulations and guidelines.
- Some knowledge of GCLP
- Ability to develop and implement project management plans, risk management 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 much 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 a high standard of ethics.
- Basic business computer skills (MS Word, Excel, e-mail)
Emoluments for Govt Job: (up to ₹ 80,000/- per month consolidated)
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