Clinical Manager II/Sr. Clinical Manager (Europe)

Clinical Manager II/Sr. Clinical Manager (Europe)

Premier Research

Sofia, Bulgaria

Description

We’re looking for a Clinical Manager II to join our team! This is a permanent role to be located in any of our European offices. Experience in Medical Device and General Medicine is required for this position.

You'll be accountable for:

  • Ensuring the effective selection, initiation and motivation of clinical study sites;
  • Planning and driving patient recruitment and retention;
  • Ensuring that the clinical team adhere to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol and client requirements;
  • Taking the initiative to move the project/program forward and leads in country and global projects where applicable;
  • Customer focused on both internal and external customers;
  • Leading and managing the clinical start-up and monitoring teams with focus on deliverables;
  • Supporting Project Management in the development and review of the protocol/study design, case report forms, informed consent forms and other documents;
  • Working with the Project Manager (PM) to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues;
  • Planning and conducting initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance where applicable;
  • Developing a clinical monitoring plan as well as clinical monitoring tools;
  • Preparing and executing a site and patient recruitment and retention plan;
  • Driving the successful activation of trial sites according to time, quality/scope and budget parameters;
  • Serving as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required;
  • Ensuring effective communication plans are in place for the clinical team and are actioned;
  • Monitoring the preparation and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues;
  • Monitoring the quality of clinical deliverables and addresses quality issues with the appropriate team member;
  • Working with the Data Management team to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk;
  • Escalating issues and provides escalation path for the team;
  • May serve in a dual CM/PM role on smaller studies.

You'll need this to be considered:

  • Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required;
  • Fluent in verbal and written English; and fluent in host country language;
  • Prior experience in clinical trial management;
  • Experience in managing complex or global trials;
  • Budget/finance experience on a project level and demonstrates a full understanding of project financials;
  • Experience in developing a Clinical Monitoring Plan;
  • Experience in reviewing Monitoring Reports;
  • Strong experience in Medical Devices and General Medicine is required;
  • Ideally you will have experience attending bid defenses;
  • This will ideally be located in one of our European offices;
  • You must be eligible to live and work in the specified country in order to apply for the role.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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