Ashik Shaikh

Ashik Shaikh Email and Phone Number

Principal, Clinical Development and Global Study Delivery Lead @ GSK
Mumbai, MH, IN
Ashik Shaikh's Location
Mumbai, Maharashtra, India, India
Ashik Shaikh's Contact Details

Ashik Shaikh personal email

About Ashik Shaikh

A seasoned professional with 14 years of experience in the clinical trial operations and project management (Phase I, II, III, IV). Held roles with increasing profile as a CRA, Lead CRA, Clinical Team Leader, Study Start Up Manager and Global Project Manager. Served as single point of contact on a global level for all participating countries (LOC/CTM) and cross functional matrix team for study deliverable and operational decision from concept protocol to study closure and final CSR. Accountable for successful delivery of studies to time, quality, budget, company and regulatory standards. Responsible for study delivery strategy, project plans, country and site selection, milestone delivery, vendor management, budget forecasting, finance management and risk mitigation etc. Successfully managed study conduct across 30+ countries including USA, EU, APAC and ROW regions for multi-therapeutic segments.Strong research professional with a Master of Pharmacy completed from Nagpur university.

Ashik Shaikh's Current Company Details
GSK

Gsk

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Principal, Clinical Development and Global Study Delivery Lead
Mumbai, MH, IN
Website:
gsk.com
Employees:
90451
Ashik Shaikh Work Experience Details
  • Gsk
    Principal, Clinical Development And Global Study Delivery Lead
    Gsk
    Mumbai, Mh, In
  • Gsk
    Principal, Clinical Development / Global Study Delivery Lead
    Gsk Oct 2021 - Present
    • Study Leadership- Leadership of a multifunctional global matrix team to ensure study oversight, study delivery and takes operational decision at study level with single point of accountability. • Study Delivery Management- Planning and leading the GSK studies to timelines, quality, budget, company standards, from concept protocol to final study report. • Protocol Development- Oversight, coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally… Show more • Study Leadership- Leadership of a multifunctional global matrix team to ensure study oversight, study delivery and takes operational decision at study level with single point of accountability. • Study Delivery Management- Planning and leading the GSK studies to timelines, quality, budget, company standards, from concept protocol to final study report. • Protocol Development- Oversight, coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports• Study Delivery Strategy- Accountability for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc)• Budget Management- Develop and manage study level budget within project budget allocation. Accountable for effectively forecast budget, track invoicing/payments and actual spend.• Risk Mitigation- Making decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate. • CRO Oversight- Accountability to drive assessment, selection, engagement, and management of appropriate vendors and third-party organization.• Resource Management- To use the resources most efficiently to manage workload within the available budget and headcount allocation. • Working with the GSK supplies team/s to manage commercial and clinical supplies.• Portfolio Management- Active partnership building for the portfolios and collaboration with therapy aligned staff in other functions. Show less
  • Cro
    Ctl/ Cra/Clinical Operations
    Cro Jun 2012 - Sep 2021

Ashik Shaikh Skills

Formulation Quality Evaluation Clinical Trial/research Design Of Clinical Protocol Monitoring Clinical Trial Ich Gcp Guidelines Basic Icmr Guidelines Schedule Y Document And E6 Guidelines Pharmacovigilance Medical Writing Ae Documentation Communication With Iec/irb And Other Regulatory Bodies Project Management Data Analysis Healthcare Market Research Negotiation Project Management Regulatory Affairs Research Sop Strategic Planning

Ashik Shaikh Education Details

Frequently Asked Questions about Ashik Shaikh

What company does Ashik Shaikh work for?

Ashik Shaikh works for Gsk

What is Ashik Shaikh's role at the current company?

Ashik Shaikh's current role is Principal, Clinical Development and Global Study Delivery Lead.

What is Ashik Shaikh's email address?

Ashik Shaikh's email address is sk****@****ail.com

What schools did Ashik Shaikh attend?

Ashik Shaikh attended Institute Of Pharmaceutical Education And Research Nagpur University, Amravati University.

What are some of Ashik Shaikh's interests?

Ashik Shaikh has interest in Economic Empowerment, Education, Science And Technology, Human Rights, Health.

What skills is Ashik Shaikh known for?

Ashik Shaikh has skills like Formulation Quality Evaluation, Clinical Trial/research Design Of Clinical Protocol, Monitoring Clinical Trial, Ich Gcp Guidelines Basic Icmr Guidelines, Schedule Y Document And E6 Guidelines, Pharmacovigilance, Medical Writing, Ae Documentation Communication With Iec/irb And Other Regulatory Bodies, Project Management, Data Analysis, Healthcare, Market Research.

Who are Ashik Shaikh's colleagues?

Ashik Shaikh's colleagues are Arpit Dixit.

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