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Clinical Study Operations Manager

Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

BA/BS with 5+ years experience, MBA/MS with 3+ years experience, Knowledge of Good Clinical Practice, Experience managing studies in Netherlands, Full right to work in UK.

Key responsabilities:

  • Manage study and site activation plans
  • Develop study level recruitment strategies
  • Ensure timely communication with stakeholders
  • Oversee vendor management and deliverables
  • Coordinate site issues and performance metrics
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Job description

ICON plc is a world-leading healthcare intelligence and clinical research organization. Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.


Working fully embedded within an ever expanding program, the Study Operations Manager will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close. The Study Operations Manager has responsibility for study management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention). You will be accountable for the execution of tasks of moderate complexity and developing solutions to problems as needed to support deliverables.

  • Regional/Country/Study level implementation of Startup and Site Activation Plans (through SUPM
  • or pCRO if assigned)
  • Regional/Country/Study level Recruitment Strategy
  • Responsible to support the development of study level plans
  • Communication with the local team and internal stakeholders and pCRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
  • Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
  • Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.
  • The Study Operational Manager will be able to work independently and exercise their own judgement


In order to be successful in this role, you must have:

  • BA/BS 5+ years of relevant experience
  • MBA/MS/ 3+ years of relevant experience
  • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
  • Full right to work in the UK
  • Although you'll be based in UK, you'll be covering the Netherlands as a market so you must have experience in managing studies in the Netherlands


Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/fb642d1f31b1ccd0b6425a57b5119fb8

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Information Technology & Services
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Problem Solving
  • Communication

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