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 : Clinical Data Manager

Projects : “Translation Research Consortium for Establishing Platform Technologies to Support Prophylactic and Therapeutic Strategies for Dengue Discovery to Proof-of-Concept”

Consolidated salary per month : Up to Rs.90,000/-

Duration : The study duration is four years. The initial appointment will be for a period of one year to be continued subject to performance.

Age : Up to 45 years

Responsibilities
• Clinical Study Protocol understanding and experience in the preparation of Data Management documents - DMP (Data Management Plan), DVP (Data Validation Plan/ Edit Checks Document), Annotated CRF, Data Entry Guideline etc.
• Quality Check of Database Design, Validation Program, Annotated CRF, Data Extract Views, Laboratory Details, Site and Investigators and Final Data Listings
• Good experience and working knowledge of CRF designing
• Preparation of Data transfer guidelines for external data load and self-evident correction chart.
• Working knowledge of Query management, data cleaning, data freezing and data archival.
• Change Requests and takes approval from sponsor
• Global library review and approval for changes
• Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project
• Sound knowledge of Clinical Database Development tools, logics and techniques and GCDMP
• Working knowledge of database standards and study development process, CDM SOPs, CDISC & SDTM standards
• AE/SAE reconciliation
• Knowledge of medical dictionaries integration and medical coding in the databases.
• Preparing interim reports and review of listings of data for clinical trial status and data extraction in collaboration with the statistician
• Maintaining and archiving of clinical study related documents
• Participates in cross functional team meetings & external client meetings as DM representative
• Generate ad-hoc reports as needed
• The data manager will ensure that security of all data is maintained and confidentiality of participants is protected.
• Managing requests for data from external third parties – including liaising with internal staff and external collaborators to provide data in a timely and appropriate manner and maintenance of a database detailing the status of such external data requests.
• Knowledge of Laboratory Information Management Systems (LIMS) to track requisition and specimen status to ensure prompt turnaround time of sample results.
• Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and immediately communicating these to the appropriate management representatives to ensure prompt resolution

• Create and/or update laboratory standard operating procedures, as needed
• Verification of information fidelity in the specimen medical record and the electronic database.
• Review information relating to the correlation of test results and final reports.
• Releasing test results to physicians in a report format.
• Effective interaction with intra-departments to ensure all required, vital information and documentation is acquired in a timely manner.
• Clinical Lab Support as needed and not limited to: Biorepository functions, Regulatory Audit support, Sample Accessioning and Receiving.
• Lead in preparation of datasets for analysis including data cleaning and ensuring compliance with the data protection.
• Development of Standard Operation Procedures and training to the study team for the implementation of medical coding in the CDMS.
• Supervise DM activities at the clinical site.

Qualifications and Experience & Desirable
Essential:
• Educated to Graduation degree level in healthcare field, IT, Computer Applications with 6-8 years in clinical data management (Clinical Data Manager/ Data Validation Associate/ Data Quality Manager). OR
• Master’s degree in healthcare field, IT, Computer Applications or 5 years in clinical data management (Clinical Data Manager/ Data Validation Associate/ Data Quality Manager).

Desirable : Diploma in Clinical research and clinical data management.
Familiarity with industry standard CDMS and some programming skills
• Preparation of Clinical Study Data Management documents

Skills
• Good management & leadership skills
• Familiarity with GCP, US-FDA 21 CFR 11, regulatory requirements and data standardization guidelines.
• IT literate (experience with Microsoft based applications and other CDMS applications)
• Must have experience in handling EDC tools
• Validation programming
• Must have understanding of clinical trials and familiarity with clinical data management functions.
• Good interpersonal, verbal and written communication skills.
• Client focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Meticulous attention to detail.
• Effective time management in order to meet metrics or team objectives.
• Commitment to project and team goals.
• Must be able to work independently but seek guidance when necessary.
• Team player with outstanding inter-personal, negotiation skills and organizational skills.
• Sense of urgency in completing assigned tasks
• Exhibits a sense of urgency about solving problems and completing work.
• Shows commitment to and performs consistently high quality work.
• Ability to model behaviors and ethics in line with CDSA Mission and Vision.

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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 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. Only shortlisted candidates will be contacted for interview
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 the maximum and can be lesser based on candidate’s experience, qualifications, skill set, etc.
8. This position is strictly project-based.
9. The list of all the shortlisted candidates for the interview, date of interview & the final 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 for attending the interview.
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.

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.

Date & Time for Walk-in-Interview10th Feb 2020 at 10:30 AM onwards.

Venue: NCR Biotech Science Cluster, 3rdMilestone, 3rdFloor, THSTI Building, Gurugram Faridabad Expressway, Faridabad (Haryana) 121001.

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 website.

Last date for receipt of online application is 10th Feb 2020