Required Skills

clinical data management sae reconciliation data analysis data review

Work Authorization

  • Citizen

Preferred Employment

  • Full Time

Employment Type

  • Direct Hire

education qualification

  • UG :- - Not Required

  • PG :- - Not Required

Other Information

  • No of position :- ( 1 )

  • Post :- 4th Aug 2022


Dear Candidate,

Mandatory Skills

Hands on experience on Medidata Rave or Oracle Inform platform (priority to Medidata Rave), hands on experience on at least 2 of the 3 phases of Clinical Data Management (start up/ set up, conduct, close out)

Purpose of the role:

Individual Accountabilities

Parameters for Success

  • Oversight of data discrepancy management
  • Owner of study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF
  • Responsible for compiling HoS content
  • Conduct the protocol amendment impact assessment and complete appropriate documentation
  • Manage migration and audit trail reports
  • Create slides for study-specific EDC investigator training
  • Provide study specific training to data manager (DM)
  • Contribute to the Data Management Plan (DMP)
  • Request DTS creation and ensure DTS finalized and complete for any LSH loads
  • Execute data review per IDRP (e.g. SAE reconciliation, PK reconciliation, short term-long term reconciliation)
  • Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)
  • Manage global and study-specific data entry conventions
  • Facilitate versioning, including:

Unlock/audit trail review

Archival process

  • Knowledgeable of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design
  • Timely communication with key stakeholders on issues and risks, including

Brings CDR, DWA, and SD together to discuss post-production changes when identified

  • Provide critical information to PL who will communicate with study team
  • Log any action issues into DS Hub and resolve outstanding issues assigned to DA
  • Mange assigned activities to meet milestone dates
  • Ask questions to get information needed to meet end goals
  • Manage programming only changes (Move to DWA for LSH and SD for EDC when SOP and T11/12 updated)

Strive for:

  • 10-day database lock
  • 0 unlocks
  • 0 document rejections
  • 0 post-production changes
  • 0 escalation from study team to TA Lead or Global Head


  • HOS slides
  • Meeting committed timelines
  • Highest-quality clinical data
  • Highest-quality documentation


  • Time zone flexibility

Key Behaviors

  • Proactively communicate ownership of studies
  • Critical thinking to identify root causes and best solutions for data discrepancy management
  • Confidence to have tough conversations and make challenging decisions
  • Enables an environment of open and honest communication and critical thinking within DSS study team
  • Influence internal team to meet timelines by holding stakeholders accountable
  • Ability to work with different personalities to get the work done
  • Willingness to seek out information to accomplish goal
  • Proactive communication

Decision Rights

(D=Decision Maker, A=Advice Giver, I=Informed Stakeholder)


Data Management Processes (A)

DS Deliverable Timelines (I)

Prioritize Workload (I)

Study Timeline (I)








Document Management

DS SMEs (DTS, Labs, IRT, etc.)


Interface Designer


Medical Coding

Medical Monitor





Randomization Personnel

Safety Management


Site Management and Monitoring

Stats/Stats Programming




CRF Processing

Data Standards Analyst

Medical Writing


TA Lead


Company Information