ZEBA TURK
Thane
Summary
- A seasoned clinical research professional with 15 years of experience in strategic planning, team leadership, and project management. Demonstrated success in enhancing operational efficiency and spearheading successful initiatives across Clinical Data Management, Centralized Monitoring, and Clinical Operations domains.
- Executed strategic initiatives that boosted department revenue by 5%.
- Formed a Budget Review Team for the department, increasing revenue by 3% per project.
- Created a tool to assist the project team in reviewing their pricing tool, identifying out-of-scope work, and ensuring these efforts are acknowledged through change orders.
- Led a team of 18 professionals as direct reports.
- Experienced in the startup, maintenance, closeout, and post-closeout phases of a trial in CDM, operations, and risk-based monitoring processes.
- Broad experience across therapeutic areas such as Oncology, Neurology, Endocrine, Cardiovascular, Respiratory, Infections, Orthopedics, Cosmetics, and Veterinary.
- Technologically adept in using EDC (Medidata, Inform, and Oracle Clinical), CTMS, various eTMF, RAMP, KRIs, TSDV, Visualization, Analytics, Smartsheet, Spotfire, patient-reported outcomes, IWRS, Mentor portal, SharePoint, and J Review.
- Coached team members to develop an audit mindset by relating daily work to principles outlined in ICH GCP guidelines.
- Skilled in managing vendors by implementing various processes to support integration and data transfer.
- Proficient in managing various stakeholders to mitigate risks to QTLs.
- Ensured positive revenue recognition by applying strategic thinking to build a budget review team responsible for reviewing client request for proposals.
- Proven track record in leading teams by fostering a culture of teamwork and innovation to enhance process efficiency and increase department revenue.
- Strong governance skills with an analytical and business-oriented mindset.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Sr Manager - CMS
IQVIA RDS Pvt Ltd
08.2017 - Current
- Consistently met or exceeded annual performance targets set by senior leadership.
- Led strategic planning sessions to align departmental goals with overall company vision, fostering cohesive growth strategy.
- Led teams of up to 28 personnel, supervising daily performance as well as training and improvement plans.
- Assisted senior leadership in managing all aspects of operations.
- Defined clear targets and objectives and communicated to other team members.
- Recruited, interviewed, and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Reviewed RFPs, SOW, strategy proposition for centralized monitoring team
- Executed appropriate staffing and budgetary plans to align with business forecasts.
- Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
- Managing Operational KPIs for various role:Central Monitors: Review of risk assessment mitigation plan, assigning CDPs to stakeholder, creating plan to perform review to identify data discrepancy, review of EDC query, identify PDs, creating programming specification, performing UAT, isitepack and maintenance of test scripts, sites issues, KRI management, and CRA coordination
- Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business.
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Collaborated closely with peers from other departments to drive organizational success jointly as one cohesive unit.
- Implemented and developed operational standards, policies and procedures.
- Achieved operational excellence by streamlining processes and implementing best practices.
- Demonstrated exceptional adaptability in navigating complex situations or rapidly changing environments with ease.
- Balanced competing priorities efficiently while maintaining focus on critical tasks requiring immediate attention.
- Implemented innovative solutions to overcome challenges, leading to enhanced productivity levels.
- Utilized data-driven insights to make informed decisions that resulted in higher returns on investments.
- Championed process improvement initiatives that led to significant cost savings without compromising on quality standards.
- Reviewed and analyzed reports, records and directives to obtain data required for planning department activities.
- Centralized Monitoring lead: Clinical operations plan, maintain eTMF health, recruitment, Site ready to enroll process, Close out activities, Payment processing, IP management, CTMS maintenance, missing pages, query management, SDV management, PD management, CRA and CTA coordination, Monitoring visit compliance
- Site report reviewer to ensure 100% compliance in reviewing monitoring visit report as per annotations and raise IEL in CTMS
- Study Analytics associate to create analytics plan and produce output to identify high risk sites and follow up with stakeholder to resolve issues
- Identified process improvement opportunities by automation
- Center of Excellence (COE) manage initiatives at department level
- Managing Risk on project to ensure minimal variance to EAC
- Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
- Governance and SME support to the Project lead, Clinical lead and Centralized monitoring lead
- Created skeletal of interactive Change order tool which support end user to perform scope change analysis for appropriate budget estimation.
- Created framework for SME and Mentor support
- Identifying process gaps and communicated to eSOP owners
- EGPS: employee growth and skill enhancement: Created framework to identify early warning signs from attrition per say
- Created Skill gap analysis tool
Manager - Clinical Data Management
Karmic Life sciences
07.2016 - 07.2017
- Providing operational insights to business Development team
- Projecting resource recruitment to the leadership team as per project pipeline
- Client Visits: Walk through organization process and e-sops
- Setting up Smart goals in alignment with business vision
- Keeping employee motivated by ensuring appropriate learning opportunities and diverse work experience
- Standard operating procedures maintenance
- Governing KPIs to ensure projects are delivered as per customer requirement
- Key participant in Bid defense meeting, SOW review to provide an estimation to client
- Internal Tool Development Key stakeholder from operations in developing EDC tool for the organization, signatory in validating document for IQ, OQ, PQ
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Controlled costs to keep business operating within budget and increase profits.
- Developed and maintained relationships with customers and suppliers through account development.
- Developed a strong company culture focused on employee engagement, collaboration, and continuous learning opportunities.
- Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.
- Developed comprehensive risk management plan, minimizing potential disruptions to business operations.
- Implemented customer feedback mechanisms to gather insights, using this information to guide strategic planning and decision-making.
- Planned, created, tested and deployed system life cycle methodology to produce high quality systems to meet and exceed customer expectations.
Team Lead Clinical Data Management
Cognizant technologies Pvt Ltd.
04.2014 - 06.2016
- People management: Performance Management, Staffing, Project Allocation, Mentoring responsibilities, Career development, Skill enhancement, Staff utilization
- Startup: Document Management-EDC structure, Data Management Plan, annotated eCRF, Visit Matrix, Data Validation Specification, Data Transfer Specification-Vendor Plan, eCRF instructions, Review manuals, LAB setting (OOR), Reports specification, Manual Check specification, Review EDC Core Configuration against study requirements and assess need for any amendments
- Conduct: Discrepancy/Query Management, listing review, Vendor reconciliation, Local and central lab review, IVRS review, e-pro review, Missing pages report, Manual Review, organizing CRA EDC training
- Close out: clean patient tracker, Database lock activities, eCRF archival
- Project Management: Reviewing scope of work, Project Planning, Project Budgeting, Change order, Project resourcing, Ensuring Sponsor, internal team is continuously appraised of project progress and risks to deliverables
- Contributor in conducting investigator meeting
- Collaborating with cross functional team Clinical Operations, Biostats, Safety, Coding, archiving team to ensure study deliverables are in line with project plan
- Data Standards team: Involved in creation, review, and testing of CRF and respective components for the library as SME
- Adoption of CDISC standards as per study requirement in creating and updating the library
- Process Team: Providing opinion in developing, revising, and maintaining core operating procedures and work instructions
- Innovation: Missing Pages Tool, Identify Data Redundancy Tool
- Trained new team members by relaying information on company procedures and safety requirements.
- Promoted a positive work environment by fostering teamwork, open communication, and employee recognition initiatives.
- Served as a role model for the team by demonstrating commitment to excellence, professionalism, and adherence to company values at all times.
- Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.
- Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
- Led cross-functional teams for successful project execution while maintaining strong collaboration among team members.
- Evaluated staff performance and provided coaching to address inefficiencies.
- Optimized customer experience by delivering superior services and effectively troubleshooting issues.
- Developed effective improvement plans in alignment with goals and specifications.
- Created and managed project plans, timelines and budgets.
Associate Clinical Data Manager
Syneos Health
04.2010 - 08.2012
- Data Processing: Paper trail - Tracking, Scanning, Indexing and Data entry
- Database set up: User acceptance testing, Creation, and review of (DMP, CRF, Visit Matrix, DVS, DTS, eCRF instructions, Review manuals)
- Data Cleaning activities: Discrepancy Management, QC, Manual review, Third party reconciliation, SAE reconciliation, DCF management
- Close out: DCF and ecrf archival, TMF documentation and archiving
- Participated in internal audits as well as inspections conducted by regulatory agencies, demonstrating compliance with industry standards.
- Developed and maintained comprehensive data management plans, ensuring compliance with regulatory requirements.
- Liaised with external vendors for seamless integration of third-party applications into existing workflows.
- Managed the transition to electronic data capture systems, resulting in increased productivity and reduced manual errors.
- Supported the implementation of new technologies and software tools to enhance data management capabilities and streamline workflows.
- Enhanced data accuracy by implementing stringent quality control measures and periodic audits.
- Reduced data discrepancies through the implementation of robust validation checks and error resolution procedures.
- Ensured accurate coding of medical terms using MedDRA or WHO-DD dictionaries, facilitating standardized reporting across studies.
- Coordinated efforts with biostatistics teams for insightful analysis reports that informed key decision-making processes.
- Performed thorough review of clinical protocols to identify potential risks or inconsistencies in study design.
- Assisted with database upgrades and migrations by performing user acceptance testing.
- Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
- Collaborated with medical teams to create uniform standards for clinical data reporting.
Clinical Data Processor
Syneos Health
06.2009 - 03.2010
- Data Processing: Paper trail - Tracking, Scanning, Indexing and Data entry
- Database set up: User acceptance testing, Creation, and review of (DMP, CRF, Visit Matrix, DVS, DTS, eCRF instructions, Review manuals)
- Data Cleaning activities: Discrepancy Management, QC, Manual review, Third party reconciliation, SAE reconciliation, DCF management
- Close out: DCF and ecrf archival, TMF documentation and archiving
- Ensured timely completion of projects by prioritizing tasks and efficiently managing time.
- Utilized established methods for data processing and analysis for consistency and accuracy.
- Monitored data entry processes and worked to improve efficiency and performance.
- Managed documents by organizing forms, making photocopies, filing records, preparing correspondence, and creating reports.
- Scanned documents and saved in database to keep records of essential organizational information.
- Created spreadsheets for more efficient recordkeeping.
- Developed and implemented data entry operations.
Education
PGDPM - Clinical Research
Academy of Pharmaceutical Management
04-2009
B.SC - Chemistry
University of Mumbai
03-2007
Skills
- Project management
- Strategic leadership
- Analytical thinking
- Coaching and mentoring
- Decision-making
- Team collaboration and leadership
- Process improvement
- Operations management
- Critical thinking
- Budget management
- Performance evaluations
- Financial leadership
Awardsrecognitions
- Recognized by department in building budget review team.
- Recognized by department for creating Mentorship Portal.
- Recognized by department for creating eGPS tool.
- Recognized by department for creating Knowledge repository for the clinical operations role.
- Cheer award for implementing strategies to meet deadline for mega covid trial.
- Recognized for pilot project implementation for Missing pages report.
Certification
- PMP, Project Management Institute, 12/01/20
- Intellectual Property Rights
Scholasticrecord
- PGDPM, Academy of Pharmaceutical Management, 2009, Clinical Research
- B.SC, University of Mumbai, 2007, Chemistry
- H.S.C., Maharashtra State Board, 2004, Science and Maths
Timeline
Sr Manager - CMS
IQVIA RDS Pvt Ltd
08.2017 - Current
Manager - Clinical Data Management
Karmic Life sciences
07.2016 - 07.2017
Team Lead Clinical Data Management
Cognizant technologies Pvt Ltd.
04.2014 - 06.2016
Associate Clinical Data Manager
Syneos Health
04.2010 - 08.2012
Clinical Data Processor
Syneos Health
06.2009 - 03.2010
PGDPM - Clinical Research
Academy of Pharmaceutical Management
B.SC - Chemistry
University of Mumbai
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