Reena Srivastava

Experience

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  Aglowmed

  Sept 2003 - Jun 2004

  Executive
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  SIRO Clinpharm Pvt. Ltd.

  Jun 2004 - Apr 2005

  Clinical Research Associate

  1. Identification of investigational sites 2. Subject Diary development3. Site qualification activities. 4. Facilitation of EC submissions. 5. Preparing pre-study documentation 6. Site Initiation activities 7. Drug & material accountability8. Case Report Form development 9. Clinical Trials Supplies Management 10. Tracking & review of completed CRFs 11. Monitoring activities 12. Adverse event & serious adverse event reporting. 13. Site Closure activities14. GCP compliance15. Query Resolution. 16. Training of new CRAs17. Investigators Meetings Show less

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  GSK

  May 2005 - Oct 2006

  Assistant Clinical Research Manager

  Key Achievements: Brought down study budget considerably through operational excellence Negotiated budgets with SMO/ vendors for Investigational product / sample storage and management.  Co-authored Local Standard Operating Procedures for Logistics. Ensured successful achievement of subject enrollment and research objectives. Promptly reported and followed-up on Adverse Events & SAEs, disseminated INDSRs.  Prepared and managed budgets & contracts for investigator sites. Conducted Investigator Meetings and regular training workshops for sites and new CRAs. Manage storage and tracking of Investigational Products at / to sites / central storage.  Took a lead role to manage recruitment, managing project budgets, investigators agreements and vendor contracts.  Demonstrated capacity and ability to deal with high volume & varied workload with conflicting priorities and changing demands.  Compilation of the regulatory dossier for clinical trial applications in IndiaAchievements: Won Gold Award at Monitoring @ GSK – I conducted by Naeem Noordin 2nd prize for India at the Bio-APACHJ Advanced GCP workshop, Singapore, 2006 Show less

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  Pulse Software Solutions LLC

  Oct 2006 - Feb 2010

  Sr. Manager
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  InVentiv Health Clinical

  Feb 2010 - Jan 2016

  Senior Clinical Project Manager

  Execute, manage, monitor and report clinical research studies using clinical trial management and document management systems, based at client site (GlaxoSmithKline)

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  GSK Consumer Healthcare India

  Jan 2016 - Jul 2022

  Principal Clinical Study Manager
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  GlaxoSmithKline Consumer Healthcare

  Apr 2018 - Jul 2019

  Regional Clinical Operations Director (Interim)

  Leadership and operational excellence at a regional (AMA) level for the execution and conduct of category and/or market initiated clinical studies and accountable for ensuring that all applicable company procedures, SOPs and expectations are followed.

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  Haleon

  Jul 2022 - now

  Clinical Operations Director - EU & APAC