Consultant Clinical Operations

vor 1 Woche

Basel, Basel-Stadt, Schweiz SwisSolution Human Capital AG Vollzeit
Are you interested in a 30% role as a consultant for the Clinical Operations team? Then keep reading

Tasks

Project Initiation & Planning

  • Manage study startup activities
  • Provide input to project tools, PL project plan, Central File Maintenance Plan
  • Provide input to the format and content for sponsor reports
  • Provide input to and oversight of site selection strategy plan
  • Develop site selection and monitoring plans for the team
  • Review and provide input into patient recruitment plan and retention plan
  • Establish efficient/effective working relationships with other functional Leaders and coordinators across geographies within a given program
  • Develop study plans, tools and forms
  • Maintains oversight of the study budget
  • Provides input into study planning and budget forecasting
Project Implementation, Control & Evaluation

  • Provide leadership and direction to project team members
  • Evaluate and identify resourcing needs and continuously monitor the use of resources over the project life cycle of the project
  • Provide productivity targets to the team and project
  • Early recognize areas of potential problems and provide input to contingency plans
  • Monitor study timelines, patient recruitment, retention and data cleaning to ensure the successful outcome of the project
  • Maintain and assure the quality of work generated and escalate and follow up as appropriate
  • Implement and instigate process improvements within the project
  • Provide input to the Revenue Recognition forecast
  • Identify changes in scope and liaise with Project Leader
  • May be required to conduct site visits as per client or project demands
  • Participate in client, investigator and team meetings
  • Prepare, participate in and follow up on audits/inspections
Project Close-out

  • Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities
  • Together with Project Leader ensure all administrative closeout procedures are completed, according to Project Closeout Checklist
  • Together with Project Leader ensure the project is archived and all documentation returned to the client as specified by the contract
  • Participate in endofstudy meeting and give input to lessons learned information and feedback relevant information into the relevant functions

Requirements:

  • Master degree or equivalent university education/degree in life science or healthcare
  • 5+ years' experience in clinical trial management (incl. early trials) is required, ideally in a biotech setup
  • Proven experience in Phase 12 in immuneoncology solid tumours is essential
  • Substantial experience in clinical research including relevant experience as a Team Leader in Clinical functions or proven experience in coordinating clinical trials.
  • Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and studyspecific procedure
  • Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)
  • Strong understanding of the crossfunctional activities
  • Leadership skills
  • Strong customer focus
  • Effective time management in order to meet daily metrics or team objectives
  • Ability to travel when required
  • Excellent written and interpersonal skills, ability to interface and communicate effectively with management and other functions within the organization
  • Fluent in spoken and written English, additional languages are an asset
  • Strong leadership skills with collaborative attitude, Team player
  • Excellent planning and strong organizational skills, able to manage multiple tasks simultaneously and set priorities
  • Excellent conceptual science thinking, which is used to approach and solve complex issues and their implications
  • Selfmotivation and able to work independently in a fastpace, small company environment
  • Proactive and problemsolving attitude
  • Willing to work handson in a very small team with limited internal resources
  • Personal resilience, perseverance, energy and drive

Benefits:

  • 5 Weeks vacation
  • Career Opportunities
  • Part time possible
  • Social events in the team
Our client is a biotech company focused on improving significantly the survival of cancer patients.

The goal is to improve survival rates by developing novel targeted anticancer therapeutics which provide a multi-pronged approach against solid tumours.

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