Data Management Clinical Research

Curriculum Vitae

Ms. Namrata Kuril Mobile: 902-***-****

(Exp–7 yrs.) E-mail address: **************@*****.*** Objective: To maximize the potential and utilize them effectively to attain organizational goals and objectives through positive attitude, flexibility, and an open mindset. To enhance knowledge for professional growth in the fields of Clinical Trial & Data Management and elevate to higher achievements in career and procure responsibilities that account based on performance and diligent work. Academic Credentials:

DEGREE/DIPLOMA YEAR OF PASSING BOARD/UNIVERSITY GRADE/PERCENTAGE Advance diploma in

clinical research

December 2016 Ace Academy of Clinical

Excellence

B Grade

BSc. (Zoology,

Chemistry, Botany)

June 2016 R.D. National College

(MUMBAI UNIVERSITY)

A Grade

HSC March 2012 Alpha College.

(Maharashtra Board)

45%

SSC March 2010 St. Charles High School.

(Maharashtra Board)

66%

Professional Summary: Professionally Distinct in 6.10 Years Expertise: 6.10 years of Clinical Data Management proficiency.

• Leadership: Specialized in Study Start-up, Conduct, and Closeout across diverse Therapeutic Areas.

• Management Excellence: Led Data Management for Multiple Studies.

• Skill Set: Proficient in Vendor Management, Quality Data Review, and Training.

• Tool Mastery: Hands-on experience with InForm 6.0, 6.1, 6.3, Rave, Rave X, J-Review, SQL, TIBCO, MS-Office, Power BI.

• Project Impact: Primary Data Manager for a new project, handling all project-level documentation.

• Strategic Confidence: Inspired Sponsor confidence, contributing to project portfolio expansion. Professional Experience:

Professional Experience Duration

Cognizant Technology Solutions, Mumbai: Feb 2017 – Aug 2019 Tata Consultancy Service: Sep 2019 – Sep 2020

IQVIA: Sep 2020 – June 2021

Cognizant Technology Solutions, Mumbai: Jul 2021 – Jun Date 2023 Syneos Health: Jun 2023 – Till Date

Key Achievements:

Critical Study Close Out Support:

• Played a pivotal role in successfully locking critical studies, ensuring seamless study close-out. DM Team Leadership:

• Served as a Point of Contact, leading the Data Management team during Set-up and Go-live activities, bringing a study into the Production Phase.

Standard Library Implementation:

• Executed User Acceptance Testing (UAT) for CDASH in the Standard Library at the Project Level, integrating standardized forms across all studies.

Business Continuity Expertise:

• Designated as the point of contact for business continuation planning, ensuring robust strategies for uninterrupted operations.

Project Expansion:

• Instrumental in introducing and establishing a new project, contributing to organizational growth and diversification.

Position: Senior Clinical Data Analyst

Key Responsibilities:

Document Management:

• Proficient in drafting study documents, including Protocols, Edit Check Specifications, eCRF Requirements, Annotated eCRF, and eCRFs Completion Guidelines.

• Skilled in creating essential documents such as Data Transfer Agreements (DTA), Data Review Plans (DRP), Data Management Plans (DMP), Project Plans, and UAT Test Scripts. Clinical Trial Phases and Tools:

• Extensive experience in managing data for Phase I, II, III, and IV clinical trials using tools like Rave, Rave X, InForm 6.1, and 6.3.

Validation and Testing:

• Proficient in drafting Validation Plans (VP), Data Validation Specifications (DVS), Data Standards Documents

(DSD), and conducting User Acceptance Testing (UAT) for database functionality. Data Management Activities:

• Expertise in Discrepancy Management, Data Listing Programs execution, and reviewing patient data for consistency, quality, and completeness.

Validation and Reconciliation:

• Well-versed in Data Validation and Reconciliation Activities of Electronic Case Reports (eCRF) through System Generated, Manual (SAS, J-Review, DQCC), and External Data, including SAE. Analysis and Reporting:

• Conducted Site Trend Analysis regularly and presented findings to stakeholders. Collaboration and Coordination:

• Coordinated with various stakeholders, including Sites, Clinical Operations Team, Programmers, Medical Coders, and CRO for outsourced studies, ensuring timely deliverables. Project Management:

• Managed project timelines delivered process training to new associates and identified areas for process improvement.

Leadership and Sponsorship:

• Led DM activities for Multi-Centric Global Studies, acted as a Sponsor for outsourced studies, and monitored CRO activities at the Sponsor level.

Audit and Compliance:

• Attended audits with positive feedback, implemented best practices, and ensured compliance with Service Level Agreements (SLA).

Project Initiation:

• Took a leadership role as the primary DM for new projects, handling all project-level documentation and activities, instilling confidence in sponsors, and increasing project size. SOP Creation:

• Created Company SOPs at the project level, covering Organizational Chart, FMEA, BCP, EFF, Team Charter, QCP, GTP, RD, CMP, Onboarding and Exit checklists, Skill competency, etc. Skills (Core Competencies):

● Skilled in Quality Review of Datasets and in Discrepancy Management.

● Proficient in InForm and RAVE and Rave X tool.

● Competent in Coordinating and Managing with different stakeholders in the study through Mails and Meetings.

● Good Communication in Spoken English and Command over Comprehension.

● Adept in handling Computer Aided Tools and the Web Platform

● Excellent Technical, Presentation and Interpersonal Skills. Certification:

• FMEA: Certified in Failure Modes and Effects Analysis (FMEA).

• Generative AI: Certified in Generative Artificial Intelligence.

• AI Tech and Data: Certified in Artificial Intelligence Technology and Data.

• Excel Proficiency: Certified in Basic-Advance Excel.

• Power BI: Certified in Power BI.

• FACET: Certified in Facilitation and Certification for Everyday Trainer.

• Ongoing Learning: Pursuing ongoing certifications in SQL and Tableau. Personal Details:

Date of Birth: 21-JUNE-1994

Marital Status: Unmarried

Address: Vakola Masjid, Santacruz (East), Mumbai 400055 Languages Known: Hindi, English, Marathi

Hobbies:

Movies, Music, Traveling, Meeting new people, Cooking, Gardening, Training, Learning new skills

Key strength:

Self-Confident, Self-Motivated, Leadership Traits, Team Player, Highly Energetic, Attention to detail, Quick learner, Flexibility and Adaptability, Decision making, Coaching people, Responsible, Goal Oriented, Prioritizing Task, Loyalty.

• Declaration: I hereby declare that the above-mentioned information is correct up to my knowledge and bear the responsibility for the correctness of the above-mentioned particulars.

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