Biswadip Sarkhel

Associate Director (Data Management & Central Monitoring) @Johnson & Johnson Innovative Medicine

Hyderabad, TG, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Nov 2024 — Present

Associate Director (Data Management & Central Monitoring) @Johnson & Johnson Innovative Medicine

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Hyderabad, IN

EDUCATION

2014 — 2016

The ICFAI University, Tripura

MBA in General Management, MBA

2003 — 2005

Bangalore University

MS, Biotechnology

2005 — 2006

Bioinformatics Institute of India, Noida

Industry Diploma, Contract Research and Clinical Trials

SKILLS

GcpTraining & DevelopmentData ValidationOncologyPortfolio ManagementClinical TrialsProject ManagementCRO ManagementU.s. Title 21 Cfr Part 11 RegulationProblem SolvingManagementPeople ManagementRegulatory AffairsCROCrf DesignProject PlanningClinical DevelopmentProject CoordinationEdcInterviewingTherapeutic AreasGood Clinical Practice (Gcp)CtmsPharmaceutical IndustryBusiness Process ImprovementInternal AuditPharmacovigilanceRaveBpoBiotechnologyMentoringProgram ManagementEmployee TrainingMedical WritingClinical Research21 Cfr Part 11InformElectronic Data Capture (Edc)Clinical Trial Management System (Ctms)Ich-Gcp

ABOUT BISWADIP SARKHEL

Career Objective: Continue to learn and grow into people development and leadership role where my knowledge, vast experiences and skills can be best utilized for the benefit of the patient community, people and organization.Summary of Professional Experience: Leadership role with people and project management experience, over 19 years experience in the large Pharmaceutical/ Healthcare/ CROs/ BPOs industry (Specialty: Clinical Data Management across all TAs predominantly in Oncology and Immunology TA. Currently working for top leading large Pharma organization and experienced in handling large global, innovative and complex projects, managing team, resource management, recruitment, training/ mentoring staffs, stakeholder management, process development/ improvement, content development, global training delivery, audit/ inspections etc. and supervising the delivery and quality of all Data Management deliverables within programs.Established and monitored performance metrics, continuous improvement initiatives, resource forecasting and planning. Well versed with Project Management methodologies and extensive exposure in planning and executing projects with strong collaboration with appropriate contingencies (staffing, schedule, and budget) and meeting project deliverable, client service quality and cost goals.

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Biswadip Sarkhel — Associate Director (Data Management & Central Monitoring) at Johnson & Johnson Innovative Medicine in Hyderabad, TG, IN | Unifers