Clinical Team Manager

  • Full-time
  • Department: Clinical Operations

Company Description

Ergomed plc provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information.

Ergomed’s fast-growing, profitable services business includes an industry leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, a full range of high-quality clinical research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR.

For further information, visit: https://ergomedplc.com.

Job Description

·         Brief summary of Responsibilities:

  • The Clinical Team Manager will be responsible for operational project management and will act as the direct project line manager to allocated study Monitors.
  • The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary
  • Direct communication with project allocated Monitors, Site Managers and CTAs
  • Direct communication and collaboration with the Sponsor representative in projects where only operational management is contracted, i.e. if no project manager  is assigned.
  • Verifying and ensuring that project team members (Monitors, Site Managers, CTAs) are trained (e.g. GCP, SOP, indication, protocol, study specific procedures / requirements, etc. ) to perform their assignments
  • Organizing and facilitating Monitors’ Meetings throughout the project. 
  • Organizing and facilitating project team meetings (e.g. weekly calls with Monitors, Site Managers, CTAs), and ensuring meeting minutes are reviewed, approved and distributed to all concerned parties
  • Developing, reviewing and revision of project documents (e.g. monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)  
  • Initiating corrective / preventative measures – e.g. update of study guidance documents, performing re-training, performing co-monitoring, etc.
  • Investigator identification and selection,

 

 

Qualifications

·         Proven experience working within clinical operations  

·         Ability to line  manage study monitors/CRA’s

·         Experience of phase 2/3 trials ideally complex studies such as oncology or rare disease

·         Able to work in a fast paced small CRO  environment and manage multiple projects

·         A minimum of a science based Bachelors degree

·         Able to work effectively with minimal supervision

 

 

Additional Information

Why Should You Apply?

·         You want  be involved in a wide range of interesting projects and studies

·         You want your  achievements  and hard work to be recognized

·         You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.

·         You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both.

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