Mourin Patnaik
Summary
Results-driven Certified Clinical Senior Data Manager with 14 years' experience in clinical research. Led diverse data management teams across global projects, ensuring high-quality deliverables and effective stakeholder communication. Actively contributed to process improvements and risk management initiatives. Engaged speaker and panelist at SCDM conferences and published in Data Basics. Expertise in Rave, Inform, Veeva, and IBM CD platforms across multiple therapeutic areas.
Overview
2
2
Languages
1
1
Certification
14
14
years of professional experience
Work History
Senior Manager
Fortrea
Bangalore, Karnataka
12.2025 - Current
- Oversaw the Data Management department, facilitated performance and career development using the PMD process, regular catch-ups, and status meetings, and clarified objectives and job responsibilities for all group members.
- Collaborate with peers to develop and/or implement global harmonised SOPs and specific quality processes and procedures for Data Management activities.
- Collaborated with peers to establish global Data Management competency models and developed training programs to ensure staff achieved required competencies.
- Supported Data Managers by ensuring studies met Sponsor requirements on time and within budget, while managing project team members and providing training.
- Assisted in selecting and onboarding new team members for departmental roles.
- Assigned objectives and training to new hires, ensuring alignment with department goals and staffing requirements.
- Contribute to the development of department strategies and objectives that align with company-wide goals and targets.
- Evaluated and contributed to the Data Management budget, tracked resource allocation, revenue, and direct costs, and achieved department financial targets and business requirements, including expected margins.
- Review and approve department metrics for input into financial costing models. Ensure that these are kept up to date and that Business Development is aware of any updates.
- Work with peers and senior management to establish global Data Management processes and initiate and/or implement process improvements to increase efficiency and to ensure standards are applied consistently.
- Actively support business development activities including participation in Bid Defenses, Request for Proposals (RFPs) and Request for Information (RFIs). Work closely with our Business Development representatives in maximising new or existing business opportunities.
- Establish and maintain strategic client relationships, managing issues and escalations efficiently and effectively, and implementing appropriate action plans to address client feedback (i.e., customer survey results) as necessary.
- Reviewed individual issues with managers and staff proactively, collaborating with supervisors to resolve concerns and maintain performance plans.
- Ensure attention is also paid to interpersonal skills and achievement of competency standards.
- Participate in client, internal or agency audits and inspections.
- Any other tasks assigned by the DM department management team.
- Any other tasks assigned by the DM department management team.
Manager
Fortrea
Bangalore, Karnataka
06.2024 - 11.2025
- Manage direct reports to ensure utilization targets are met or exceeded, per job grade.
- Managed direct reports to ensure timely assignment and completion of training, maintaining up-to-date training records.
- Supervise, mentor and evaluate performance of direct reports to ensure career development, interpersonal skills, and achievement of competency standards.
- Collaborated with DM leadership team to foster teamwork and advance strategic initiatives.
- Build and maintain good DM relationships across internal functional units and sponsors.
- Escalate any potential or actual issues to project team, upper management and/or sponsor company in a timely manner with suggested resolution and follow issues through completion.
- Assisted in developing and executing training programmes, ensuring compliance with project-specific and global DM processes.
- Participate in recruitment of new staff to DM.
- Manage financial responsibilities regarding personnel and project expenditures.
- Executed resource planning and management.
- Oversaw office management tasks such as schedules, desk assignments, business continuity planning, and disaster recovery.
- Maintain a comprehensive understanding of Fortrea DM SOPs, Work Instructions (WI) and guidance documents.
- Possess knowledge of all company procedural documents that impact DM.
- Assist with the generation and review of SOPs, Work Instructions etc., when applicable.
- Distributed relevant information from internal and external meetings to direct reports and appropriate colleagues.
- Demonstrate role specific Competencies and company values on a consistent basis.
- Oversaw the line-management of DM staff.
- Executed assigned tasks to improve operational efficiency.
Associate Manager
LabCorp Drug Development
Bangalore
07.2022 - 05.2024
- Manage direct reports to ensure proper training is assigned, completed and training records are up to date.
- Manage direct reports to ensure utilization targets are met or exceeded, per job grade.
- Supervised, mentored, and evaluated direct reports to foster career development and meet competency standards.
- Oversaw the line-management of DM staff.
- Participated actively in DM Leadership team to enhance decision-making processes.
- Communicated relevant information from internal and external meetings to direct reports and appropriate colleagues.
- Escalate any potential or actual issues to project team, upper management and/or sponsor company in the timely manner with suggested resolution and follow issues through completion.
- Assisted in developing and executing training programmes, ensuring staff compliance with project-specific and global DM processes.
- Carried out resource planning and management to ensure efficient allocation of assets.
- Managed office responsibilities, such as schedules, desk assignments, business continuity planning, and disaster recovery.
- Maintain a comprehensive understanding of Labcorp DM SOPs, Work Instructions (WI) and guidance documents.
- Took on the role of Study Lead and assisted with data management tasks.
- Possess knowledge of all company procedural documents that impact DM.
- Contributed to the creation and assessment of SOPs and Work Instructions.
- Participate in recruitment of new hires to DM.
- Build and maintain good DM relationships across internal functional units and sponsors.
Lead Data Manager
Premier Research
Bangalore
12.2020 - 06.2022
- Ability to facilitate clinical database development to execute the collection, receipt, reporting, review and archiving of quality clinical trial data. Includes eCRF planning discussions, coordination of eCRF review, planning and identification of system and protocol specific edit checks, coordination and execution of User Acceptance Testing, and coordination, planning and development for external data sources.
- Ability to create, maintain, execute and store data related documentation as outlined in department operation procedures and as required by study.
- Managed functional area eTMF filing and executed quality control activities as per study.
- Oversaw financial planning for study, ensuring adherence to budgetary constraints and supporting effective resource allocation.
- Reported study metrics and financials based on project requirements.
- Collaborated with internal and external project team members, including external data source vendors, to ensure alignment on project goals.
- Trained data team members on study-specific protocol requirements.
- Contributed to early study team planning of data risk assessment and ongoing evaluation of risks throughout study lifecycle.
- Collaborated with the study team to provide information for re-scoping.
- Actively contributes to study team discussions, standing meeting agendas, meeting attendance and review and/or documentation of minutes.
- Executed all tasks in alignment with SOPs, department guidelines, and data standards.
Associate Data Team Lead
IQVIA
Bangalore
03.2017 - 12.2020
- Manage end-to-end delivery of data management services for single/multiservice projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction.
- Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables.
- Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
- Oversaw the management of the scope of work and budget for projects, ensuring alignment with client expectations.
- Acted as primary point of contact for customer on data management deliverables.
- Delivered comprehensive data management expertise to Clinical Data Management (CDM) team, ensuring high-quality data management products met customer needs.
- Cultivated strong customer relationships, enhancing communication and trust.
- Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
- Facilitated resolution of unresolved data issues by collaborating with client data managers, vendors, and internal team members.
- Implement proactive quality management plan. Identify any service and quality issues with agreed-upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve.
- With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
- With guidance, create and/or review and sign-off on all data management plan (DMP) documents.
- Identified and documented tasks that fell outside the agreed scope of work for accurate project management. and track change orders to completion.
- Followed good clinical practices and regulatory guidelines in data management.
Senior Clinical Data Coordinator
IQVIA
Bangalore
10.2015 - 02.2017
- Coordinated project delivery throughout full data management study life cycle, ensuring adherence to timelines and quality standards.
- Manage project timelines and quality; determine resource needs; identify out of scope work.
- Executed comprehensive data management tasks, including data review and resolution of data clarifications, to enhance data accuracy.
- Perform comprehensive quality control procedures.
- Achieved set objectives through effective planning and execution.
- Cultivated effective communication and collaborative relationships with CDM team to facilitate project success.
- Interact with CDM team members to negotiate timelines and responsibilities.
- Acted as Data Operations Coordinator (DOC) and Data Team Lead (DTL).
- Solve issues through using the global issue escalation/communication plan.
- Understand and comply with core operating procedures and working instructions.
Clinical Data Coordinator
IQVIA
Bangalore
11.2013 - 09.2015
- Conducted comprehensive data reviews to ensure accuracy and integrity of clinical data.
- Wrote and resolved data clarifications to enhance data quality and compliance.
- Developed and tested databases while editing specifications to meet project requirements.
- Led database audit team.
- Achieved assigned objectives through effective planning and execution.
- Developed and maintained good communications and working relationships with CDM team.
- Understand and comply with core operating procedures and working instructions.
Clinical Research Associate
Novo Nordisk
Bangalore
08.2012 - 10.2013
- To conduct site initiation, site monitoring and site close out visits as per the agreed timelines and prepare a report as per the timelines.
- Monitored source data verification as per protocol, ICH-GCP, NN SOPs, and local regulations; ensured safety reporting, drug accountability, and regular maintenance of trial files and archiving of trial-related documents.
- Assisted Project Manager (PM)/LTM in selecting sites, contributing to efficient study setup.
- To coordinate and support the LTM/PM for the smooth conduct of the study in a swift and efficient manner.
- Coordinated with Regulatory team for HA dossier preparation and submission, ensuring compliance with submission timelines.
- To coordinate with the Local Trial Manager (LTM) for EC dossier preparation and submission.
- Conducted audits and inspections to ensure compliance with regulations.
- Contributed insights during Investigator and Monitor meetings.
- Shared effective practices to improve consistency in Clinical Operations.
- Maintained updated training logs for medical information and NN SOPs.
- To work with peers in the company to ensure that the focus on quality is continued.
Education
PG - Clinical Research & Management
CREMA
India01-2013
B. TECH - Biotechnology
AMITY
India01-2011
Skills
- Data management systems
- Clinical trial management
- Veeva platform expertise
- IBM CD platform knowledge
- Oncology treatment strategies
- Cardiovascular health
- Endocrinology insights
- Gastrointestinal disorders
- Infectious disease control
- Dermatology practices
- Orthopaedic care
- Psychiatric services
Languages
English
Proficient
C2
Hindi
Proficient
C2
Certification
- Certified Clinical Data Manager
- Certified in Lean Sigma- MOOC Lean Practitioner
- Barnett GCP Accreditation
Custom
- As a Trainer, contribute to comprehensive training for new employees, for experienced data operations roles and also for new Data Team Leads on job roles and responsibilities.
- Development of processes improvement documents which enable eliminating redundancy and improving efficiency.
- Subject Matter Expert on Study Start Up, Custom reports and IBM CD platform.
Timeline
Senior Manager
Fortrea
12.2025 - Current
Manager
Fortrea
06.2024 - 11.2025
Associate Manager
LabCorp Drug Development
07.2022 - 05.2024
Lead Data Manager
Premier Research
12.2020 - 06.2022
Associate Data Team Lead
IQVIA
03.2017 - 12.2020
Senior Clinical Data Coordinator
IQVIA
10.2015 - 02.2017
Clinical Data Coordinator
IQVIA
11.2013 - 09.2015
Clinical Research Associate
Novo Nordisk
08.2012 - 10.2013
PG - Clinical Research & Management
CREMA
B. TECH - Biotechnology
AMITY