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Operations Manager, Clinical Trials

Role overview

Qualifications

  • University degree in life sciences
  • Minimum 5 years of clinical on-the-job experience, in a leadership position at a CRO or SMO
  • Fluent use of local language, at least C1 level of English
  • Proficiency in MS Office

Responsibilities

  • Assess feasibility of research protocols based on knowledge and experience
  • Supervise the conduct of clinical trials in accordance with ICH GCP and applicable regulations
  • Manage the team of Lead Coordinators and oversee the quality of their work
  • Build and sustain long-lasting relationships with existing and potential clients

Key facts

Other skills

  • Team Leadership
  • Quality Control
  • Training And Development
  • Communication
  • Presentations
  • Problem Solving
  • Accountability

About the company

PSI CRO AG  logo

PSI CRO AG

Contract Research Organizations (CRO)

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

Company details

Company typeLarge
IndustryContract Research Organizations (CRO)
Company size1001 - 5000

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Job description

Company Description

At Milestone One, we’re transforming access to clinical trials by expanding research site networks and fostering strategic partnerships with medical institutions. Our mission is to connect patients, physicians, and sponsors in a seamless ecosystem that accelerates breakthrough treatments.

With over 30 years of global experience, we are a team of industry experts dedicated to quality, innovation, and collaboration. As our Operations Manager, you’ll play a key role in driving our business expansion through leading the local team and building strong, long-term partnerships with clinical research organizations and medical institutions.

Job Description

  • Assesses feasibility of research protocols based on knowledge and experience and in accordance with designated criteria to select the most suitable studies for the clinical site.  
  • Supervises the conduct of clinical trials in accordance with ICH GCP, applicable regulations, procedures, and protocols, by monitoring the safety of patients, completeness of research documentation and proper study conduct. 
  • Monitors individual stages of budget negotiations and research timelines. 
  • Manages the team of Lead Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and any other available tools to ensure satisfactory performance of the MO1 team. 
  • Ensures continuous improvement and standardization of the research process, its continuity and consistency with ICH GCP, regulations, procedures and research protocols by co-creating operational procedures, templates, guidelines related to the work of medical staff and the site in clinical studies. 
  • Creates a work culture environment that promotes process transparency, high performance and openness. 
  • Manages and supervises the teams’ work, ensuring the development of individual team members through regular, open feedback, periodic support meetings, providing training and guidance.  Provides performance evaluation in accordance with the employee evaluation system to maintain motivation and commitment at work.  
  • Supervises and participates, when necessary, in audits and inspections, supports the Milestone One team and the medical team at the site by ensuring a reliable and smooth audit process. 
  • Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).
  • Support network development activities by active promotion of Milestone One brand by acquiring new clinics and new medical institutions to the network.

Qualifications

  • University degree in life sciences
  • Minimum 5 years of a clinical on the job experience, in a leadership position at a CRO or SMO 
  • Fluent use of local language, at least C1 level of English 
  • Proficiency in MS Office 
  • Valid driver’s license 
  • Excellent communications and presentation skills
  • Excellent Management Skills 
  • Effective problem solving and result oriented 
  • Accountable 
  • Team Leadership Skills 

Additional Information

Accelerate your career with Milestone One!

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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