Rajni Sharma

Database Used: Medi-data RAVE.

Responsibilities:

• Serve as primary point of contact for customer on data management deliverables
• Maintain strong customer relationships.
• SME for the Central LAB and automation tools and providing the training to the new joiners as well as the cross vendors.
• Ensure open communications with customer and Syneos Health management to manage and meet contractual obligations.
• Meet with CDM team members on regular basis to ensure milestones meet timelines and quality deliverables.
• Establish strong communications with CDM team, functional leads, project managers and all other stake holders.
• Serve as escalation point for unresolved data issues.
• Plan, manages and requests resources for assigned projects.
• Develop and maintain project plans, specifications and documentation in line with SOP requirements.
• Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date.
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings.
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits.
• Trains and mentors data management staff
• Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables.
• Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per DMP and contract/SOW and work with functional manager(s) to resolve.
• With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions.
• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables.

Achievements:

• Received “Clinical Award-2022” for outstanding performance, productivity and dedicated service.
• Actively participated and volunteer in the PHUSE & ISCR single day event conducted in Syneos

Database Used: Medi-data RAVE and INFORM, J review.
Responsibilities:

• Perform database and edit check testing activities (User Acceptance Testing)
• Perform data review and query generation
• Assisting to update the database to correct errors
• Attained client calls (teleconference and face to face) on weekly basis, and resolved the study related issues
• Assist in tracking project progress and issuing periodic status reports
• Participate in completion of all activities necessary for the finalization and transfer the clinical database and related project documents to the sponsor
• Assist in identifying the achievement of milestones
• Coordinate the work of associate clinical data managers assigned to the project.
• Provide training on data management procedures and systems
• Develop and design CRFs, or participate in the review of sponsor-generated CRFs.

Achievements:

• Received Silver award for the outstanding performance, productivity and dedicated service.
• Appreciated frequently for work on all the projects assigned, by all stakeholders including client and internal project leads.

Database Used: OC-RDC and J review.
Responsibilities:

• Review and understand the Study Protocol, Data Management Plan (DMP) and Study Plan Specification (SPS).
• Preparing Mock CRF, Edit checks for newly added pages and exiting pages and proving input in case if the checks are getting misfired.
• Create test scripts and perform database testing By User Acceptance Testing (UAT).
• Updating CRF completion guideline (CCG) and provide inputs on entering the CRF page.
• Performing subject site transfer.
• Tracking the scheduled Metric reports for study specified in the data management plan (DMP).
• Uploading all study related documents on study portal.
• Updating study related issues in DHP on ongoing basis.
• Updating Study plan specification.
• Create study specific reports on daily and monthly basis from the J review.
• Performed conduct activities on OCR/RDC.
• Create Patient position in database and request study access for the team members as per the study resource allocation.
• Perform discrepancy management and manual listing review with the customization of J review reports.
• Perform Third Party Data Reconciliations for (ECG, LAB, IVRS) and record the issues in Change Request Form.
• Identify and investigate issues while conduct of the study with creation of post- production change (PPC) request form if required. Accordingly update affected document and perform UAT of the changes.
• Raising Manual query’s for study specific protocol deviation (PD’s) and providing inputs to the clinical team if in case there is a discrepant data.
• Record protocol deviation (PD’s) into the database and share the reports with
• clinical team as per the DHP.
• Performing pre-lock data cleaning activities as per the checklist provided
• Generate queries to clarify and improve the quality of the data.
• Worked on Data cleaning activities prior to data base lock.
• Prepare presentation to CRAs on the topics where site lacks understanding or critical pointers for database lock.
• Perform Database lock activities as per the checklist.
• Develop lessons learnt deck to share with the project team.

Achievements:

• Appreciated frequently for work on all the projects assigned, by all stakeholders including client and internal project leads.
• Process initiative: Analyzing and customizing or creating J review reports as per the project requirement to reduce the manual work.
• Received Wow award and Star Team Award for the outstanding performance, productivity and dedicated service.

Responsibilities:

• Responsible for managing clinical trial information and data collection in accordance with appropriate regulatory guidelines (ICH- E2B, E2E, E2A etc.).
• Retrieval of clinical trial information from clinical trial registries of more than 50 countries for updating proprietary Clinical Trial Database.
• Profiling Clinical Trials of NCT (ClinicalTrial.gov), UMIN, Eudra-CT, ISCRTN, CTRI, IRCT, NTR, ACTRN, DRKS, Chinese Registry, Japic-CT, RBR, KCT and Conference Papers, etc
• Summarize the clinical trial results on the bases of safety and efficacy.
• Disease Reports Writing, Clinical Trials Analysis, Data Analysis, Statistics and Interpretations
• Supporting consultants & project manager to develop result driven strategies including critical industry or market analysis and opportunity assessments.
• Review and extract industry related information from various global and local databases and publications for information regarding drugs market.
• Apart from carrying out market analysis and managing in-house tools, write research report on various drugs and diseases.
• Undertake primary and secondary research in pharmaceuticals and clinical trials.
• Perform the tasks of documenting project-specific data management and data entry guidelines to ensure consistent and efficient data processing.
• Handle responsibilities of assisting clinical data specialist in areas of documenting, testing, and implementing clinical databases.

Achievements:

• Got pre placement offer (PPO) after completing my internship in the company.
• One of the top employees, who achieved 10,000 clinical trial registries updating work in tight schedule.
• Got 4 times weekly performer award for achieving quality and quantitatively targets for Pharma e- track.