Dr Reddy’s Hiring Clinical Study Manager

Dr Reddy’s Hiring Clinical Study Manager

15 April, 2022

About the job

  • This role is responsible to colloborate with the project director and project team to deliver Clinical projects for the Biologics Development organization. Also responsible for project planning, tracking and monitoring the project progress including vendor selection in collaboration with Project Director and other stakeholders. Also resonsible to trake the invoices and payments that in line with contractual agreements.

Act as point of contact for repository of study timelines (Study Gantt); all study specifiic contracts; invoices

  • Coordinate with Project Director and other study stakeholders to generate detailed project Gantt
  • Coordinate with DRL Insurance team to obtain the all insurances and extension/amendments if any
  • Coordinate with study start-up specialist for timely execution of CDA, Clinical Trial Agreements etc.
  • Perform periodic reconcilliation of study budget
  • Genarate and repository of project LE in consultation with project Director
  • Schedule project team meetings in coordination with Project Lead; capture minutes and take inputs from all stakeholders to finalize slide deck, and file all meeting material at respective study folders

Prepare detailed study timelines and track the progress against the timelines 1)Get falimiarize with study and program timelines

  • Cooninate with all study stakeholders to prepare detailed study gantt from study start-up till study archival
  • Publish the study timelines and track the study milestones and esclate the delay if any to project director
  • Revise study timelines in case of change in scope in alignmenet with project director
  • IN ORDER TO ensure that the study team adhares to study timelines and deliver the project within study/program timelines

Generate detailed study and site budget

  • Prepare overall study budget derived from program budget in consultation with project director
  • Prepare and provide Quarterly/HY/Annual LE for the study in consultation with finance and PD
  • Track and ensure compliance to study budget and esclate to PD/PL in case of budget esclations
  • Track site specific budget in line with signed CTA
  • IN ORDER TO ensure that the study budget is managed within approved study budget

Facilitate sign-off of Study contracts and insurance(CTAs, Work/Change Orders) 1)Coordinate with relevent stakeholders to ensure timeliy execution of site agreements

  • 2) Prepare per patient fixed and passthrough cost in coordination with project lead
  • 3) Reconcile the site specific budget and track spends periodically
  • 4) Coodinate with relevent study stakeholders for execution of study agrements with vedndors and track the spends
  • 5) Coodinate with central insurance team to obtain study/site specific insurance for CTA filing and EC filings and faciliate updates periodically
  • IN ORDER to ensure that the study is initiated at respective investigational sites; contracts are in place before initiation of study specific activities and also to ensure that the study is executed within study budget.

Facilaite conduct of project meetings 1) Organize and schedule study speciifc meetings with agenda, deck in consulation with PD/PL and project team members

  • 2) Capture miniutes of meeting and share it with PD/PL for review and approval
  • 3) File all meeting material in repspectibe study folders and update as necessary
  • INORDER to faciliate the coduct of meetings with good meeting practices and share relevent study updates with project team

• 6-8 years of experience in Project Management preferably in clinical trial execution

• Should have excellent communication, negotiation and interpersonal skills

• Ability to work with functional/cross functional teams, should be sincere, diligent & assertive

• Should have problem solving ability, work ethics & integrity, right attitude & positivity, and willingness to learn and contribute

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