Clinical Development Services Agency (CDSA) mission is to create, develop, and nurture world-class clinical product development capacity in India.
Post: Clinical Data Coordinator (Surfactant Study)
Emoluments/ Duration: (Rs. 71,000 per month, consolidated) for 24 months
Job Profile
Essential Function: The essential function is to independently organize and manage all clinical data management activities on projects (commensurate to their job role), being able to take on the role of DM Lead as required. Ability to solve problems using logical and systematic approaches is critical. Must have solid understanding of therapeutic indications and study hypothesis. Acts as consultant to teams for data management issues and represents department at meetings and presentations. Possesses either an in-depth knowledge in all areas relating to project initiation, ongoing processing and lock, or be considered an expert in a specific area of data management. Work to the appropriate standards of quality and efficiency.
Key Accountabilities
- Assume the ability to meet the requirements of a Data Manager with a high degree of proficiency and autonomy
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to others in an open, balanced and objective manner
- Take on role of DM Lead for the project, taking accountability for the full range or specific expert area of data management services. Ensure quality, timeline and productivity requirements are met or exceeded. Included in this are project planning and implementation, milestone tracking, organization and participation in team meetings, monitoring progress and providing updates as required
- Manage all phases of data management activities from study start up to database lock
- Direct team members in daily activities
- Provide support and mentoring to project team members (including Primaries) on acceptable DM procedures, processes and concepts to ensure the highest standards of quality, productivity, planning, client service and compliance are achieved
- Provide input into improving and monitoring Data Management Standards and participation in continuous process / productivity improvement
- Facilitates cross functional team meetings and follow up on action points
- Assist in troubleshooting CRF receipt and page numbering issues.
- Assists Clinical Data Manager in preparation of QC plan and project specific as well as processes related documentation.
- Maintenance of DMTMF (Data Management Trial Master File).
- Assist Data Manager in creating, reviewing and processing Data Clarification Forms, quality control and updating clinical databases for ensuring data validity as per the protocol
- Responsible for entering, reconciling and validating data in Clinical Database leading to robust database design. Assists in creation and enters test data for Clinical Database for screen validation.
- Assist in maintaining and updating Data Management Plans and any other relevant Data Management documentations for ensuring efficient database creation and maintenance.
- Assists with Data Entry and Reconciliation as needed or assigned.
- Assists in review of manual data listing as needed.
- Interfaces with Quality Control Manager, SAS programmers, CDP (Clinical Database Designer), CRAs and other Project team.
- Resolving DCFs will enable data cleaning leading to qualitative database
- Effective generation, resolution and updation of DCFs
- Timely reconciliation of data in database
- Comprehensive Data Review of CRFs for doing trend analysis
Qualifications and Experience
- Bachelors/ Master’s degree
- Minimum of 5 years’ experience of working in Data Management at CRO or Pharmaceutical Company.
- Background in Medical Terminology will be preferred.
- Good understanding of CDSCO GCP and CDISC standards
Skills
- Effective verbal and written communication skills, effective team player, interpersonal skills, high learnability, very high level of integrity, ability to work amidst demanding timelines
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 “Clinical Data Coordinator (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.
Recruitment Notice No. CDS/RN/03/2015
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)
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