International Clinical Trial Manager

Switzerland, Basel-City, Basel Headquarter

defresrutritptzhja

Apply now!Print

• Job facts

Objectives and Scope of Position:

• Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations

Summary of Main Responsibilities:

Provides direction and leadership to one or more clinical operations teams (depending on competency level ICTM may not have leadership responsibilities)

• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management


• Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.


• Creates team culture and promotes team spirit.


• Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external providers and collaborative partners.


• In collaboration with functional management, coaches, supports, and provides study specific direction to Study Management team members.


• Oversees the development and maintenance of study specific manuals created by the ICTA

Responsible and/or Contributes to the development and management of the study timelines, resources, budget, risk and quality plans

• Responsible to identify and update operational tracking tools, including systems to meet the needs of the operations team and ensures reporting to the ICPL


• Develops and manages clinical study budgets. Communicates variances in the budget and action plan for resolution to the ICPL. Establishes study milestones and ensures accurate tracking and reporting of study metrics

Provides clinical operations expertise to ensure operational feasibility and delivery

• Develops the site feasibility questionnaires and creates the study level patient recruitment plan and retention strategies based on feasibility data and input from the CRO and affiliates and in consultation with the ICPL and TAL


• Analyses the feasibility data across countries with input from the affiliates and provides the strategic country and site distribution and patient numbers to the ICPL.


• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes

Oversees forecasting of clinical/non-clinical supplies

• Designs drug assumption and supply chain process in partnership with Drug Supply Coordinator, affiliates and ICPL


• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study

Delivers the operational elements of the study plan

• Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings (depending on competency level)


• Ensures that safety reporting is established and maintained for the duration of the study and that reporting timelines are met


• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the ICPL and implements contingencies in consultation with the ICPL


• Primary contact with CRO and affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action


• Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits


• Oversees the maintenance of drug supplies and resolution of issues with input from Clinical Drug Supply coordinator


• Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs


• Provides operational input into the development and tracking of SMT goals

Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work

• Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution


• Develops and executes appropriate site and CRO/vendor audit and quality plans in collaboration with PDQ

Identifies areas of best practice and process improvements

• Participates in initiatives and programs as assigned.


• Maintains oversight and ensures consistency of the operational aspects across studies within a project

Ensures study adherence to ICH/GCP and SOPs

Compliance:

• Is responsible for acting in line with legal, regulatory and company standards and codes of practice (e.g. Roche Code of Conduct, applicable Roche directives, guidelines and SOPs)


• Completes all required training modules as a priority

Professional and Technical Requirements:

• Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment

Experience, Skills, Knowledge

Responsible and/or Contributes to the development and management of the study timelines, resources, budget, risk and quality plans Responsible to identify and update operational tracking tools, including systems to meet the needs of the operations team and ensures reporting to the ICPL Develops and manages clinical study budgets. Communicates variances in the budget and action plan for resolution to the ICPL. Establishes study milestones and ensures accurate tracking and reporting of study metrics

Other:

• Some travel may be required to attend study related meetings

Roche is an equal opportunity employer.

Research & Development, Research & Development > Clinical Operations

• Who we are
  
  Roche is an equal opportunity employer.


• Job facts
  
  
  
  • Location Switzerland, Basel-City, Basel Headquarter
  
  
  • Function Research & Development
  
  
  • Subfunction Clinical Operations
  
  
  • Schedule Full time
  
  
  • Job level Individual contributor
  
  
  • Job type Regular
  
  
  • Division Roche Pharmaceuticals
  
  
  • Posted since 2018/09/24
  
  
  • Posted until 2018/11/24
  
  
  • Job-ID 201807-115663
  
  


• Get in touchMr. Artur Prib


• You could also like these jobs

  Associate Medical Director/Medical Director, Crenezumab (Late Stage Development Neuroscience)

  United States of America, California, South San Francisco

  International Clinical Trial Manager

  Switzerland, Basel-City, Basel Headquarter

  Associate Medical Director / Medical Director cobimetenib / atezolizumab / vemurafenib

  United States of America, California, South San Francisco

Apply now!