Page * of * **-Jan-****

Project Manager, Operations Manager, Business Developer, Leader, Lead, Data manager, Case Monitoring, Risk management, Medical Safety, Reporting SUMMARY

Bachelor of Ayurvedic Medicine and Surgery (BAMS, 12 + 6 years); Post Graduate Diploma in Clinical Research

(P.G.D.C.R., 1 year); Master of Business Administration - Major: Operation Management. My last assignment was at Cytel Statistical Software & Services Pvt. Ltd., Bangalore as a Location Head. Exceptionally organized, detail-oriented, outcome-focused clinical research Data & Operation Management experience in CRO and Healthcare Industry.

CAREER OBJECTIVE

Expert Data & Operation Manager now seeking to harness 16+ years' experience of managing and monitoring global clinical project teams and systems to make a positive contribution in the CRO/Healthcare industry. PROFILE & KEY STRENGTHS

Thorough understanding of FDA, GCP and ICH guidelines and its requirements Manages and provides direction to the clinical operations team Identify and communicate study-related issues

Manage financial integrity of all the assigned studies Provide general leadership in relation to each individual trial and effectively collaborate with other departments to meet all timelines and goals

Data Analytics and Data Management

Overseeing the time and effort tracking for the resource Conducts monthly study budget reviews with executive leadership, plans, and implements change Effectively manages change processes as they impact research operations and staff Provide input for study budgets

Conduct Vendor evaluation

Develop, review, and maintain project timelines

Monitor project progress activities effectively

Deal confidently with difficult situations; highly motivated, dynamic and single-minded in my pursuit of excellence and have a record for maintaining high standards of verity and precision in the organization Strong ability to identify and develop change strategies, establish cultural change and monitor efficacy of changes Possess strong working knowledge of computer system;

Windows Family

Information Management System

LIMS (Q - Lab Information Management System)

EDC (Q - Build)

SDTM, CDISC

SAS 9.4 (User Level)

MS office 2007, 2010, 2016 (Word, Excel, PowerPoint, Outlook)

MS Project 2016

Curriculum Vitae SWAPNIL JANKAR

23204, Wisdom Drive, Cary, North Carolina, 27519, United States of America Contact: 919-***-****; Email: adu8oz@r.postjobfree.com Page 2 of 5 27-Jan-2023

PROFESSIONAL EXPERIENCE

Consulting Doctor, Bangalore, India. Apr 2019

Patient care.

Cytel Statistical Software & Services Pvt. Ltd., Bangalore, India. Aug 2016 – Mar 2019 Designation: Location Head (Asst. Manager)

Key Responsibilities:

Responsible for Operation, Sales & Marketing.

Identify and implement process improvements.

People Management.

Corporate Training.

Business Strategy.

Develop and maintain the standardize tools and training materials. ISTA Ayucare & Research Pvt. Ltd., Bangalore, India. Aug 2015 – July 2016 Designation: Center Head

Key Responsibilities:

Center Monitoring.

Staff Management (Doctors and Support Staff - SOS). Inventory & Pharmacy Stock Management.

Business Development (Adv. & Marketing).

VISHWAMITRA HEALTHCARE & RESEARCH PVT. LTD., Bangalore, India. Jan 2013 – Jul 2015 Designation: Consultant

Key Responsibilities:

Patient care.

Center Monitoring.

Staff Management (Doctors and Support Staff - SOS). Inventory & Pharmacy Stock Management.

Business Development (Adv. & Marketing).

QUINTILES LAB DATA MANAGEMENT. Bangalore, India. Jun 2011 – Oct 2012 Designation: Asst. Lab. Clin. Data Analyst/ Data Manager Key Responsibilities:

Client Data Requirement Management (Large Data Handling and Data transfers). Develop database in association with developer and programming team. Create, review, and maintain project timelines.

Manage & monitor progress of Global Studies.

Keep senior management within the business unit fully informed of any project issues that may impact the quality and Page 3 of 5 27-Jan-2023

timeliness of project delivery to the customer’s satisfaction. Generate and process statistical data sets.

Ensure completion of all data management activities prior to database lock. QUINTILES CARDIAC SAFETY SERVICES. Bangalore, India. Designations: Holter Specialist Jun 2010 – May 2011 Key Responsibilities:

Receive, Analyse and Report Holter Recording

Collect Snapshot of ECGs from the Holter recording. Provide MCC (Metrics Champion Consortium) Metrics to the management. Client Management.

QUINTILES CARDIAC SAFETY SERVICES. Bangalore, India. Designations: Operations Study Specialist Feb 2008 – May 2010 Key Responsibilities:

Analyse and Report ECG Recordings.

Coordinate with different functional team members, e.g. Project Management, Clinical Data Management, Lab Operations, Logistic and Healthcare Professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues.

Provide regular feedback to operations team manager and Customer Delivery manager (CDM) on project metrics, out of scope work, challenges/issues and successes.

Conduct internal audits and assist MR during the external audits. QUINTILES CARDIAC SAFETY SERVICES. Bangalore, India. Designations: Cardiology Associate Jan 2005 – Jan 2008 Key Responsibilities:

Receive, Analyse and Report ECG Recordings (Trans-Telephonic, Paper, Digital). Maintenance, review and validation of QC Procedures. Train new hires and conduct timely refresher trainings. Operational Lead.

QUINTILES CARDIAC SAFETY SERVICES. Bangalore, India. Designations: Consultant Cardiology Associate Oct 2003 – Dec 2004 Key Responsibilities:

Receive, Analyse and Report ECG Recordings (Trans-Telephonic, Paper, Digital). Maintenance, review and validation of QC Procedures. To train the new hires and conduct timely refresher trainings. PUBLICATIONS, DOCTORAL THESIS

Page 4 of 5 27-Jan-2023

Basics Of ECG Reading, Journal of Family Medicine; 2005. Rheumatoid Arthritis, Ayurvedic Chikitsalaya; 2002. CERTIFICATIONS

Barnett – Good Clinical Practice For Administrative Support Staff; 2011. Internal Audit - Transition to ISO 9001:2008.

Indian Society of Electrocardiology; 2006.

MEMBERSHIPS IN PROFESSIONAL ORGANIZATIONS

Registered Ayurvedic Medicine Practitioner; 2003

Member Of Maharashtra Council of Indian Medicine; 2003 EDUCATIONAL & PROFESSIONAL DEVELOPMENT

MASTER OF BUSINESS ADMINISTRATION (MBA – In System & Operation Management); 2010 POSTGRADUATE DIPLOMA IN CLINICAL RESEARCH (PGDCR); 2005 BACHELOR OF AYURVEDIC MEDICINE & SURGERY (BAMS); 2003 WORKSHOP ATTENDED

Good Clinical Practice (GCP); Good Manufacturing Practice (GMP). Clinical Trials Regulatory Requirements – India; ISO 9001:2008 (Quality Management System – Requirements). Cross-Cultural Business Communication; Conflict of Interest Management. Setting & Writing SOP’s.

Managing your Time and your Meetings; Influencing & Negotiating; Problem Solving & Decision Making. Email Etiquette; Better Business Writing.

Ethics at Work; Effective Meetings.

Personal Effectiveness; Team Power.

Preparation of Audits and Common Audit Findings.

EXTRACURRICULAR ACTIVITIES

Credentials of being the Sport Secretary in Smt. KGMP College (2000-01). Participated and won accolades in Inter College meets in Chess, Carrom and Cricket. Hobbies: Reading, Traveling & Learning new technology. Language Proficiency: English, Hindi & Marathi

Page 5 of 5 27-Jan-2023

PROFESSIONAL REFERENCES

Name: Rajneesh Patil

Title: Vice President, Clinical Operations

Organization: IQVIA, USA

Phone Number: 919-***-****

Email: adu8oz@r.postjobfree.com

Working Relationship: We were associated with each other while working on different initiatives in IQVIA. Name: Priyanka Agarwal

Title: Senior Manager, Clinical Data Management

Organization: IAVI Bellevue, WA, USA

Phone Number: 682-***-****

Email:

Working Relationship: We were associated with each other while working on different Data Management Projects in Quintiles now IQVIA.

Name: Milan Adesara

Title: Manager, Statistical Programming

Organization: IQVIA, India

Phone Number: 91-990-***-****

Email: adu8oz@r.postjobfree.com

Working Relationship: We were associated with each other while working on different study Projects at CYTEL STATISTICAL SOFTWARE & SERVICES PRIVATE LIMITED.

Contact this candidate