Ref No.

CO-20-1

Location

US ~ Miami

Clinic Manager (Clinical Operations Manager)

Company Overview

Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success.  With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

 

The Role

  • To ensure delivery of clinical studies on time and to a high quality by managing and co-ordinating staff to maximize operational efficiency
  • To ensure study data is collected to a high quality in accordance with ICH–GCP
  • To provide management support to ensure subject safety at all times
  • To provide leadership and guidance to the clinical team
  • To ensure excellent clinical standards within the clinic

Main tasks and responsibilities will include:

  • Provide leadership, encouragement, support, positive reinforcement and job enrichment opportunities to direct reports by undertaking regular 1:1s, objective setting and regular team meetings
  • Effectively manage clinical team to ensure the smooth delivery of studies
  • Attend clinical scheduling meetings to ensure co-ordination of the clinic team to maximize operational efficiency
  • Organising training for both new and existing members of the clinical team
  • Ensure all members of the clinical team are fully trained and signed off in the relevant SOP/competency before working unsupervised or on a study
  • Troubleshooting and problem solving to support clinic leads or a ward/shift lead as and when required
  • Administration of dosage forms as required (with appropriate nursing licensure)
  • Clinical duties e.g. collection of blood samples, taking blood pressure, ECGs etc. as required by resource allocations
  • Oversight of compliance and delivery of the study when in clinic ensuring data collection is to a high standard and performing quality checks accordingly
  • Ensure study KPIs (PDs and Query metrics) are within the set targets ensuring regular feedback to the team on trends/issues/learnings throughout the study and on completion. Feed improvements into the data quality workstream to drive continual improvement within the clinic
  • Monitor compliance and support audit readiness at all times by ensuring monthly departmental inspections are conducted per the agreed schedule
  • Ensure all clinical aspects required to comply with the GCP, global policies and SOPs are conducted and documented accordingly
  • Support QA with general audits, regulatory inspections and site visits as needed
  • Support PM and commercial team in general site visits to win business
  • Support screening activities via Nurse Led Information sessions, Informed Consent and medical histories according to the needs of the business

Other tasks and responsibilities:

  • Ensure clinical equipment is maintained in good working order
  • Ensure logbooks are maintained in accordance with SOPs
  • Writing and updating clinical SOPs where required
  • Proactively promote working in a safe and responsible manner at all times
  • Interviewing and appointing new staff to clinical team
  • Investigate quality issues and identify appropriate CAPAs
  • Identify opportunities for change and assist with implementation of process change
  • Monitor Clinical budget with Senior Director, Operations

Job Demands

The job may involve the following:

  • Very high concentration of work
  • Ability to prioritise, delegate and make decisions
  • Strict and tight deadlines
  • Having to juggle a range of tasks/issues simultaneously
  • Ability to work to a high specification
  • Working in a hazardous environment with high requirement to follow safety procedures
  • Working outside normal business hours
  • Needing to respond to client demands

 

The Candidate

  • M.S. degree in health or science related field preferred
  • Extensive experience of a clinical environment, preferably Phase I research
  • Extensive experience of managing people and shifts
  • Significant knowledge of GCP requirements and a good understanding of the Phase I accreditation guidance
  • Preferably nursing qualification or alternative qualification/experience

 

Company benefits

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

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