CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,
An autonomous organization of 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 - 1/PM-1/2016
Name of the post/ Emoluments/ Duration :Project Manager (Surfactant Study)
(up to Rs. 75,000 per month, consolidated) for 30 months
Job profile
• Managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met
• Managing study-related vendors and serving as the primary point of contact for contracted vendors, study staff and contract labs; identifying potential risks and resolving issues with vendors; establishing vendor management plans and reviewing quality metrics
• Providing input into and/or developing study related materials such as Clinical Monitoring Plans, Data Management Plans, CRF forms and completion guidelines, informed consent drafts, site instructions for specimen collections, study drug order forms and study related documents
• Reviewing monitoring reports, protocol deviations and data listings to ensure quality data are delivered; coordinating with sites for site assessment, IEC submissions, site initiation and close-out planning
• Communicating with study site staff and investigators for tracking patient recruitment and progress to study timelines; supporting safety reporting and IEC submissions; maintaining and reporting metrics for clinical site performance
• Performing and/or overseeing site monitoring visits for clinical trials as needed
• Coordinating the negotiation of site budgets within guidelines, and providing oversight for site payments per contracts
• Facilitating site study drug orders, and ensuring site accountability records are maintained
• Providing oversight to project staff maintaining study master files to ensure their compliance with required regulatory and GCP quality standards and consistency with CDSA SOPs
• Providing input and support to maintain appropriate documentation for adverse event safety monitoring, and collaborating in submission of safety reports to DCGI, and other applicable authorities
• Providing support to sites to prepare for clinical audits and to respond to audit findings conducted by internal QA and external agencies
• Work with Trial Management Committee (TMC) and other Governance Committees to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding, or timelines
• Organising internal and external meetings like International Advisory Board (IAB), Steering Committee (SC), Data Safety Monitoring Board (DSMB), Trial Management Committee (TMC) and Implementation & Data Coordination Committee
• Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Qualifications and Experience
MBBS/BDS/ BHMS/ BAMS/ BPT or Masters in medical sciences, human life sciences, pharmacy, healthcare or other related discipline with minimum 3 or more years of clinical project management or 7 years in Clinical Operations experience in clinical trial projects.
Skills
• Leadership skills that include ability to build effective project teams, ability to motivate others, delegation, drive and timely/ quality decision making
• Personal qualities that include the ability to gain trust and confidence with stakeholders.
• Operational skills including focus and commitment to quality management and problem solving
• Influencing skills including negotiation and teamwork
• Effective communication skills that Include the provision of timely and accurate information to stakeholders
• Ability to develop and implement clinical research monitoring plans, SOPs, database concepts, and formats
• Understanding of GCP, regulations and guidelines
• Excellent Computer skills (MS Word, excel, internet)
• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
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 Chairman of the Interview Committee, in case candidates are otherwise well qualified.
5. 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 “Project Manager (Surfactant Study)” to cdsa_admin@thsti.res.in
6. Only shortlisted candidates will be contacted for interview
7. Incomplete applications will stand summarily rejected without assigning any reasons
8. 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
9. This position is strictly project-based.
10. All results will be published on our website and all future communications will be only through email
11. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement for attending the interview.
12. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
13. Canvassing in any form will be a disqualification.
14. The last day of application is every Saturday of the week. If candidates are short-listed, they will be called for interview on the following Friday or other days based on the availability of interviewees.
Those who have applied earlier need not apply again.
For more info,visit http://www.cdsaindia.in/cdsa-openings |
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