GSK

Senior Clinical Trail Assistant

Employer
GSK
Location
Rockville, MD
Salary
Competitive
Posted
November 06 2020
Ref
270463
Organization Type
Pharma
Are you looking for an opportunity to share your knowledge of how evidence generation and research studies are conducted, reported, and published? If so, this is the role for you.

TheSeniorCTAisthereferenceandmentorfortheotherCTAsintheLOCandwilltypicallybeinvolvedinmorecomplexstudies.TheSeniorCTAwillalsobeinvolvedasSubjectMatterExpertinprojectsabovecountry.Thisrolewillalsobemuchmoreinvolvedinchecksonregulationchangesandmorecomplexproceduresallinkeepingtheaccountabilitywiththefunctionalmanagers.Thisroleisexpectedtotakeinitiativeandtoproposesolutionstoproblemsastheyarise.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Regulatory and Ethics
  • Assist timely regulatory submissions.
  • Liaise with investigators to ensure timeous application to and satisfactory approval of clinical trials by the appropriate ethics committees.
  • Assist with collation of clinical trial progress reports for regional and national ethics committees and regulatory authorities, as well as for GSK internal use.
  • Tracks any changes in local regulations and drives local implementation and communication towards management on this and proposes actions.


Support to Clinical Trials often involved in more complex studies
  • Maintain eTrack
  • Maintain TMF throughout the course of the study according to departmental SOPs and ICH- GCP.
  • Manages the collection, submission and review of important trial related documents
  • Assist in ordering and shipping of clinical trial materials to sites
  • Support translations of study related documents where applicable
  • Manage user access for clinical trial related systems (e.g Inform, SBIR, Team sites)
  • Tracks and maintain safety reports reported in compliance with regulatory authorities, GSK SOPs and ICH-GCP.
  • Track study level safety reports and disseminate safety information as per local regulation and GSK SOPs.
  • Maintain and disseminate study contact lists and trackers
  • Assist as needed with site selection activities
  • Maintain study sharing databases and accesses
  • Support the Organization of study specific meetings
  • Provide assistance to CRA/LDL during the course of the trial.
  • Maintain working relationship with investigators and staff


Finance Support
  • Assist with processing and tracking of study budgets. Ensure timeous processing and tracking of invoices and payments and liaising with Finance when necessary reconciliation of all invoices delivered to finance dept and confirmation of all inter-company cross-charges
  • Placement of orders and tracking of their delivery.
  • Assist COM/LDL to track study/department budgets Set-up of new vendors/POs in the SAP system
  • Analyze study budgets, conduct reconciliation and report variances


Process Improvement
  • Acts as Subject Matter Expert - might be involved as such as well in above country initiatives
  • Maintains and revises current processes
  • Pro-actively proposes process improvement, SOPs, policies, guidelines, etc
  • Focus on continuous improvement of clinical trial processes.
  • Participate in peer review processes
  • Identify as expert to collaborate in the different Process improvement initiatives (e.g Champion role: e-TMF, e-Track Cold Chain, etc)


Maintain GSK 's Professional Quality and Research Values
  • Complies with both local and corporate SOPs, ICH-GCP Guidelines and other statutory regulations to ensure quality standards are achieved.
  • Complies with Regulatory and IEC/IRB requirements.
  • Always being proactive in issue detection, escalation and resolution
  • Assist in setting up new employees on relevant systems and completing documentation
  • Assist in Completion and tracking of ABAC related activities


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree
  • 5+ years of experience in similar roles
  • Experience within the Pharmaceutical Industry, clinical operations, and project management


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Graduate or Bachelor level with relevant working experience in pharmaceutical / scientific environment.
  • Scientific background and knowledge of clinical trials (including ICH- GCP) is an asset.
  • Finance experience is a plus.
  • Computer literate -Word, Excel, PowerPoint, Outlook, SAP
  • Knowledge and understanding of ICH GCP
  • Knowledge/experience in Veeva Clinical Vault a plus
  • Previous experience in feasibility and clinical site selection preferred as well as document management in study start up.


Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.


#LI-GSK

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