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Job Details

Senior Clinical Operations Manager

Company: CTC Resourcing Solutions
Location: Basel, Switzerland
Reference: 895678-P
Closing Date: 21 Mar 18
Type: Contract
Salary (£): On Application
Benefits:

Job Summary:

Our client is a middle sized, fast growing pharmaceutical company and is currently looking for a

Requirements:

Reference Number:         895678-W

Type of placement:         Contract, +12 months

Location:                        Switzerland, Basel

Purpose: Responsible to manage CROs conducting paediatric trials and to ensure that the deliverables are provided on time, to a high level of quality and adhering to Company requirements.

Serves as deputy for other SCOM’s and/or COM’s, can serve as deputy for Clinical Operations Lead depending on expertise and experience level

 

Main Responsibilities

  • Directs the planning, set-up and conduct of pediatric trials (phase 1 to phase 3)
  • Prepares trial budgets, forecasts, timelines, and project plans
  • Negotiates contracts and budgets for assigned clinical trials
  • Ensures close CRO surveillance and management of other third party vendors (central labs, IWRS/IVRS provider if applicable, secondary packaging)
  • Manages the core team and delegates tasks to team members
  • Reviews clinical study protocols and provides input
  • Reviews and/or prepares other trial related documents (manuals, guidelines, visit reports, newsletters)
  • Prepares clinical trial supplies projections and ensures the availability of a supply chain during the whole conduct of the trial
  • Performs UATs
  • Prepares and leads internal and external kick-off meetings, monitoring workshops and investigators meetings
  • Supervises training programs to assure consistency and compliance in conduct and monitoring of clinical trials
  • Prepares and distributes ad hoc reports, summaries, or analyses as required
  • Prepares status reports for assigned clinical trials
  • Conducts co-monitoring visits
  • Participates in internal/external audits
  • Participates in dissemination of clinical information to the core team members, as appropriate

   Qualifications and Experience:

  • A minimum academic degree in Life Sciences, Pharmacy or Medicine is required
  • An advanced academic degree (M.S., PhD, PharmD, or MD) is preferred.
  • Minimum 7-8 years of progressively increasing clinical development experience within the pharmaceutical industry on a global level with experience in hospital and/or intensive care unit clinical trials
  • Profound experience in clinical operations/clinical trial management especially in outsourced global phase III trials
  • Monitoring experience
  • Excellent leadership/ management skills including excellent problem solving and team building skills
  • Excellent communication and presentation skills
  • Ability to resolve and make judgements regarding administrative, scientific and/or clinical problems without supervision
  • Ability to deliver oral presentations and write in a clear, focused, and concise manner
  • Fluent written and spoken English is a must, German and French will be an advantage
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Apply for this job: Senior Clinical Operations Manager

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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