Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.

Post : Project Manager - POD (1)

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)

Emoluments : Up to Rs. 1,00,000 per month

Duration : For 2-12 Months

Location : CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad

Age : Up to 45 years

Job profile
Project Manager (PM) is responsible for the overall coordination and management of clinical trial from initiation through close out 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 project and ensure solutions are implemented.
• Oversees project management and quality management processes and provides guidance and support to project teams to meet quality standards.
• Ensure that 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 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 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.

Qualifications and Experience
• 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: Atleast 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 of 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 high standard of ethics.
• Basic business computer skills (MS Word, Excel, e-mail)

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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 the number of position and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
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 2-12 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.
13. Submission of application will be thru online mode only otherwise it will get rejected or ignored.

Procedure for filling online application:
a. Before filling up the online application, keep the following documents handy:
i) A soft copy of your passport size photo and signature. (only jpeg/jpg format, file size 50 kb maximum)
ii) A comprehensive CV (PDF format only, file size 1 mb maximum) containing details of qualification, positions held, professional experience/distinctions etc. iii) The documents in support of educational qualification and experience (PDF format only, file size 1 mb maximum) as mentioned below:
• Matriculation Mark sheet
• Intermediate Mark sheet
• Graduation Degree/Mark Sheet
• Post-Graduation Degree/Mark Sheet
• Ph.D degree
• Relevant experience certificates
• Caste certificate in the format prescribed by the Govt. of India, if applicable
• Disability certificate in the format prescribed by the Govt. of India, if applicable
• List of Publications (if any)
• List of patents (if any)
b. Candidates are requested to use Google Chrome internet browser for best results in submission of online application.
c. Once online application is submitted, no correction/ modification is possible.
d. In case of difficulty in filling up the online form, please send an e-mail to mahendersingh.cdsa@thsti.res.in
e. On successful submission of your application, a pop up window will appear showing the reference number. Please keep a note of the reference number for future correspondence.
f. Only technical queries will be resolved (if any), other than technical will not be entertained.
g. 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.