CSRBOX

Clinical Data Manager

Clinical Data Manager

Organization: Translational Health Science and Technology Institute (THSTI)

Apply By: 21 Jan 2020

Location: Faridabad(Haryana)

About the Organization:

Translational Health Science and Technology Institute (THSTI) is a society registered under the Societies Registration Act XXI of 1860. They are also an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India. THSTI has grown from an idea to an institution that is ready to take their place with leading science institutions in the country, but differentiates themselves by being aimed beyond discovery research, to the fostering of application through its own efforts and through partnerships.

About CDSA:

Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases.

Position: Clinical Data Manager

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

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:

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

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

Emoluments: up to Rs.90,000 per month consolidated

Age Limit: Up to 45 years

How to apply

In case of difficulty in filling up the online form, please send an e-mail to mahendersingh.cdsa@thsti.res.in

Last date: 21st Jan 2020

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