Work With Us
At Vibgyor, we value our people as our biggest talent because each individual is integral to the success of our company. So what distinguishes Vibgyor from all the rest? Our Vision, energy, leadership, and the fact that we encourage every employee to explore their potential and bring out the best in them!
We are always on the lookout for enthusiastic and talented individuals who can share our vision and want to excel in what they do.
If you wish to be part of this fast growing, vibrant organization and are on the lookout for an exciting work opportunity, please send in your resume to hr@vibgyorcare.com
CURRENT VACANCIES
- Sr. Clinical Research Associate
- Data Entry Executive
- Laboratory Technologist experienced in Cold Chain Management
Clinical Data Manager (Team Lead)
Desired Candidate Profile
- The desired candidate should have 3+ yrs of experience in clinical data management. 2
- Master Degree in related discipline.
- Strong working knowledge of clinical research, good business awareness and expertise in all phases of a clinical trial with comprehensive knowledge and understanding of ICH-GCP.
- Demonstrated ability of highly development problem solving with excellent interpersonal and communication skills and proven experience of managing conflict effectively.
- Excellent organization, time management and computer skills.
- Excellent written and spoken English and good cross cultural sensitivity.
Experience Required: 3 – 5 Years
Education Required : UG – Any Graduate – Any Specialization PG – Any PG Course – Any Specialization
Job Description
- To effectively direct the activities of the data management department, projects and staff in a manner that ensures all functions, projects and tasks are handled with the highest quality, on time and within budget.
- To direct the day-to-day management of the data management department in a manner consistent with SOPs, regulations, and policies.
- Business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes.
- Maintain confidentiality of management information.
- Responsible for ensuring consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects.
- Review, analyze, and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
- Review and approve CRF design, data review ground rules and database design according to Standard Operating procedures and protocol. Develop and review new data management SOPs.
- Review and monitor the preparation of the overall department budgets, by evaluating cost control, timelines and project quality status.
- Track and analyze metrics for CRA Management duties and implement agreed corrective actions and /or further training as required, ensuring quality and productivity performance targets are achieved.
- Maintain clinical trial data accuracy through review of case report forms for completeness and consistency.
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.
- Provide input, review, and maintenance of global working practices and standards.
- Contribute to the development of the Data Management organization through his/her leadership role within the DM Group.
- Maintain current knowledge of Clinical Data Management practices and developments in the industry.
- Ensure that the appropriate documentation of training is maintained.
- Appropriate experience and understanding of at least one clinical data management system (e.g. Oracle Clinical, Clintrial) and a programming language (e.g. SQL, SAS).
- Ability and experience in the successful liaison with sponsors
Clinical Data Associate
Desired Candidate Profile
- Basic understanding of GCP and ICH guidelines.
- Bachelor degree in related discipline.
- A minimum of 2 years or equivalent experience in clinical data management.
- In addition candidate should be computer literate and possess good verbaland written English language skills.
- Hands on experience on EDC/RDC.
Experience Required : 2 – 4 Years
Education Required : UG – Any Graduate – Any Specialization PG – Any PG Course – Any Specialization
Job Description:
- Performs responsibilities according to CDM Project Plan, SOPs and Sponsor specific requirements.
- Performs internal CDM QC audits of the clinical database against the CRFs including query results for paper studies under the Supervision of CDM.
- Maintains organized, complete and up-to-date study documentation for the project team
- Coordinates receipt, handling, and reconciliation of data received from external sources (e.g central laboratory, ECG, sponsor coding dictionaries, format libraries, transfer database specifications etc) where applicable.
- Participates in the training of CDAs by assisting in the development of training plans, conducting training sessions, executing training or mentoring new associates.
- Demonstrates a general understanding of each assigned protocol, critical tasks and milestones.
- Ensure completeness, correctness and consistency of routine clinical data and data structure.
- Assisting in the implementation of routine clinical data management process with CRO including data entry, data quality checking, data transfer, reporting, backup, and recovery.
- Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process.
- Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner.
- Identifies, tracks, and resolves routine queries. Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.