Clinical Data Management

ERM Placement Services (P) Ltd
  • Kolkata
  • 13-18 lakh
  • 4-8 years
  • Views
  • 06 Mar 2017

  • Operations

  • BPO/ ITES/ Call Centers
Job Description

Coordination of all the Data Management activities.
Review and provide input to Project Data Management Plan
Participate in Study Kick Off meetings and all study related meetings
Support both protocol and procedural training to external vendors and investigators site whenever required
Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required
Design and deliver agreed status reports at a study level by ensuring the status of delivery of all service components and any sub-components at a study and global level
Responsible for overall quality and integrity of study database for assigned studies
Responsible for tracking the various data management activities using study reports/metrics
Accountable for responding to post DB lock questions/queries
Drive continuous improvement in process, quality, and efficiency to achieved decreased cycle times, assurance of timeliness and optimal quality in accordance to Cognizant expectations
Ensure that reports are delivered as per client requirements
Achieve Individual SLA targets set as well as collective study level targets set for the team
Ensure compliance of all process requirements is not less than 100%
Ensure that the buffer resources are maintained on the project.
Ensure Productivity Improvement plan is as per the contract or established organization norm
Ensure team productivity levels are achieved as per the targets set year on year
Complete all mandatory training and certifications for self and team
Identify development needs and ensure training fulfillment for the team (to be tracked against the training plan)
Contribute to Recruitment (measure through participation in screening and interviewing candidates)
Good Team Management (Indicated through good Skip level feedback and no major escalations)
Zero client escalations and DB unlocks/ SLA misses (due to Cognizant reasons)
Adherence to Quality Management process
Communicate with clients in the course of managing assigned responsibilitie, provide status updates and maintain continuous channel of communication as well as in the resolution of issues and ongoing deliverables
Manage study level and team level issues and escalation as a primary point of contact
Identify and escalate critical issues proactively and also act on those issues accordingly
Ensure timely completion of study deliverables by the team
Maintain a culture of high customer service
Ensure adherence to Cognizant and Client SOPs as per client specific agreements
Contribute to Best Practices and Innovation
Participate and lead organizational initiatives for process improvements, skills improvement, trainings etc.
Interact effectively with other safety data managers to promote resource sharing and sharing of best practices across work areas, functions and sites.
Interact effectively with other Clinical data project leads to promote resource sharing and optimal resource utilization.
Database Set Up
o Review and test CRF and database setup activities on the assigned project in a timely and efficient manner
o Review generated queries to clarify and improve the quality of the CRF and database to be designed
o Review programmed validation procedures
o Provide technical expertise in the production and delivery of the study implementation services
o Responsible for overall quality and timely completion of post-production/data migrations
o Keep abreast of function related issues / activities for effective operation.
o Responsible for overall quality and integrity of study database for assigned studies
Data Administration
o Load lab data into databases, perform QC of lab slips and revert back with the findings to the client
o Responsible for reviewing all quality documents and performing quality audits along with Group Lead
o Maintain study documentation and meet configuration management requirements
o Oversee a group of studies (may belong to the same molecule or TA or any other grouping as per client requirements)
Data Discrepancy Management
o Perform data management activities on the assigned Client protocols and give inputs for additional activities in a timely and efficient manner
o Perform assigned reconciliation of serious adverse events (SAEs) in the safety and project databases on the Client protocols
o Generate queries to clarify and improve the quality of the data
o Prepare study documentation like validation procedure specifications, Level-1 corrections documents, CRF filling guidelines etc. for the assigned study.
o Track metrics specified in the data management plan (DMP) or equivalent document
o Responsible for timely metrics generation, review, & trend analysis of studies
o Participate in process discussions with process teams both internal and that of the client
o Analyze data from the Safety database and Project database
o Review issued queries for data points that exhibit unacceptable discrepancies, document the status of events in a reconciliation spreadsheet, update the safety database and Update Project database with query resolutions, closing out queries
o Ensure that all Safety Data Management activities are conducted in compliance with relevant regulatory requirements
o Ensure teams adhere and meet SLAs and KPIs for the project, highlight potential slippages and take corrective actions
People / Team
Provide work direction and guidance to team members: ensure accuracy of the work of team members, their ability to operate under deadlines and to work on multiple tasks
Establish systems and procedures in the team
Participate in People management and resource/work allocation across projects and highlight resource issues to the supervisor
Conduct team building activities to enhance motivation
Mentor and coach new team members for the job and old members to take on new roles and responsibilities
Conduct knowledge transfer sessions for new joiners in the team
Ensure that team members adhere to quality norms and processes
Ensure timely completion of tasks assigned
Provide annual performance appraisals of direct reports and provide regular feedback, if applicable to Supervisor (During Appraisal / whenever asked for)
Conduct internal reviews for team members
Impart and conduct process & quality training to team members
Engage with team members to seek feedback
Ensure completion of training plan for all direct reports
Report to the manager on performance, status and any escalations
Resignations / Absconder communication to Operations Manager
Manage attrition and absenteeism
Demonstrate and promote Cognizant global value system across all interactions
Support recruitment efforts for the team
Executes standard responsibilities fairly independently under established guidelines for self and team with regular reviews. Refers to supervisor typically for specific interventions / exceptions.


Job Posted By

Sanchali
Senior Manager Key accounts

About Organisation

ERM Placement Services (P) Ltd