RAJESH KANNA
Project Manager
Bangalore
Summary
PROFILE SUMMARY: A professional, possessing 13.4 years experience in managing clinical trials and teams globally in the data management domain. Involved in the various stages of clinical trials from defining project scope, schedule until Archival final report. Having a track record for optimum productivity, efficiency and delivering many process improvements Key work domain: Project Data Manager (PDM), Liaison to CROs, Manage teams (Internal/external) Other work domain: SOP & Process Trainer, NovoDOCS superuser & Subject Matter Expert
Overview
23
23
years of professional experience
1
1
Certification
2
2
Languages
Work History
LEAD DATA MANAGER
NOVONORDISK
10.2020 - Current
- PDM for trials; trial outline to CTR approval
- Key Trial squad member & Liaise with CROs/affiliates
- Input to WO, RFPs, study cost
- Design CRFs & input to Blinding plan, DMP, R&R
- Inputs DVP, DMM, TDP, cSDRG, CTR etc
- Drive KOM, ongoing status from SG/CROs/vendors
- Handle escalations (Internal/External) & work with OS manager on vendor challenges
- Trial closure, post DBL, TMF archival
- Key responsibilities (Operation):
- Oversee CDMs activities, Conduct team meetings
- Enhance performance through feedback/coaching
- Identify trainings for the team
- Conduct review of all personal binders
- Goal settings & year end appraisal for teams
- Work with Senior Director to identify required team skills and capabilities
- Forecasting resource requirements & allocation
- Conduct interviews.
TRIAL DATA MANAGER
NOVO NORDISK
01.2018 - 09.2020
- 2.5 years
- Primary contact for DM
- Manage DM activities with global teams
- Responsible for Trial outline, MMA & Protocol review
- Perform trial planning, trial set up, end-to-end overview
- Create DMP, Blinding plan and review vendor documents
- Oversee multiple trials & acquire project report from CDM, TDP, SDTMp
- Setup various meetings with responsible stakeholders
- Ensuring project consistency of the clinical systems and ensuring CROs, laboratories and other vendors adhered to company standard requirements
- Regularly, hold & Facilitate meetings with study team & stakeholders
- Responsible for ensuring trial closure and post DBL activities
- Ensure archival completeness accordance to clinical trial report needs
Associate TRIAL DATA MANAGER
NOVO NORDISK
04.2014 - 12.2017
- Start to end overview of trials
- Review paper CRFs, create DHP, BP
- SIV participation, Coordinate with CDM
- Inputs to lab specs, annotations, DFP, TVP, RDLs etc
- Follow up trial progress with Stakeholders i.e CDMs, TDP, CDW mapper, Monitor
- Ensure timelines
- Post DBL DM deliverables
Senior CLINICAL DATA MANAGER
NOVO NORDISK
09.2013 - 03.2014
- Review CRFs when needed and coordinate with TDM for setup activities
- Create Data Flow Plan, TVP and loading of External data
- Perform Data Validation ensuring completeness and clean data
- Have trial status meetings with Trial Data Manager & study group
- Chair DQRC, DBL decision meeting and ensure Freeze the database
- Perform DBL.
Senior CLINICAL DATA COORDINATOR
NOVO NORDISK
07.2011 - 08.2013
- Performed discrepancy Management activities as ITDM
- Performed Medical coding (WHODD/MEDRa)
- Regular trial status meetings with HQDM
- Perform DBL with HQDM
PROCESS SPECIALIST
ACCENTURE
04.2008 - 07.2011
- Preparing daily workloads for team members & co-coordinating the daily allocation of work
- Perform discrepancy management, External Data Reconciliations, SAE reconciliation
- Chairing weekly team meetings, focusing on targets & achievements
- ACCOMPLISHMENTS:
- Awarded best poster - GDM conference (2015 & 2018), DK
- Best performer - Summit awards (twice)
- Presented at various forums/levels to Corporate Vice President, VP (Scientist & DM)
- Onsite interactions with trial Investigators at various regions (China, US, Germany, Spain, Denmark)
- Phase 1 project standardization lead
- Key member; SOP update group, Global phase 1 SBP, Standardization group
- Key member; take Action committee (Fitness, Food & transportation)
- Liaised with industry leading CROs & affiliates; ICON, Altasciences, Paraxel, Profil, Celerion, Cognizant, TCS, Quintiles, Charite Research etc
- Systems knowledge; RAVE, INFORM, MEDRIO, OPEN CLINCA, DATALAB, CLINTRIAL, ORACLE – Paper/RDC
- Multiple Inspections & Audit exposures
- First to successfully pilot CRO projects for phase 1 trials
- 35+ Clinical Trials exposure (Multiple therapeutic areas & Phases)
LEAD DATA MANAGER
NOVO NORDISK
01.2000 - 01.2009
- Project Management Professional (PMI
Education
Bachelor of Pharmacy -
Dr
M.G - undefined
R, Medical University
Diploma in Computer Application - undefined
Indian Institute of Computer Education
Skills
Good with MS project, spreadsheets & slidesundefined
Accomplishments
Projects Handled"
Piloted DWM for Novonordisk
Project Manager - DMW
Piloted Sponsor-CRO trials
Trial Template Owner
Certification
PMP (PMI)
Timeline
PMP (PMI)
12-2021
LEAD DATA MANAGER
NOVONORDISK
10.2020 - Current
TRIAL DATA MANAGER
NOVO NORDISK
01.2018 - 09.2020
Associate TRIAL DATA MANAGER
NOVO NORDISK
04.2014 - 12.2017
Senior CLINICAL DATA MANAGER
NOVO NORDISK
09.2013 - 03.2014
Senior CLINICAL DATA COORDINATOR
NOVO NORDISK
07.2011 - 08.2013
PROCESS SPECIALIST
ACCENTURE
04.2008 - 07.2011
LEAD DATA MANAGER
NOVO NORDISK
01.2000 - 01.2009
Bachelor of Pharmacy -
Dr
M.G - undefined
R, Medical University
Diploma in Computer Application - undefined
Indian Institute of Computer Education
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