Skip to main content

This job has expired

Clinical Project Manager **New

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Start date
1 Dec 2021
Closing date
31 Dec 2021

View more

Discipline
Clinical Research, Clinical Project Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

On behalf of my client, a global pharmaceutical company, we have a new vacancy for a Clinical Project Manager to join the Dublin team.   Reporting to the Head of Clinical Development.   The role will provide for a hybrid opportunity allowing partial remote working with the added benefit of working on site with the team.

PRIMARY ROLE DESCRIPTION:

AS Clinical Project Manager you will manage the day-to-day activities of the clinical studies. You will be key participant in the overall development of the drug development strategy working directly with both internal and external stakeholders to ensure the best possible service.

DUTIES:

  • Creation of strategy for qualification and selection of CROs for clinical studies.
  • Develop relationships with CROs to ensure that patient enrolment and data collection are completed in accordance with study timelines and objectives; escalates key risks with particular attention to timelines and budget as needed.
  • Work with the CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • Oversee clinical activities and quality by monitoring CROs through reviewing visit reports, protocol deviations, key risks and CAPAs; attend co-monitoring visits as required.
  • Enable studies progression by ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
  • Develop, review, and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, project plans and other study-related documents.
  • Coordinate / plan investigator meetings and/or site and CRA training.
  • Perform financial management, including review and approval of site and vendor invoices.
  • Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
  • Perform review and QC central clinical files and trial master files.
  • Identify potential study issues and recommend and implement solutions or corrective actions as needed.
  • Serve as a liaison and resource for investigational sites, review investigator contracts and site payments.
  • Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
  • Organise and manage internal team meetings and other trial-specific meetings.
  • Participating in the development, review and implementation of departmental SOPs and processes.

KEY REQUIREMENTS AND QUALIFICATIONS:

  • BSc or MSc with minimum of 5 years pharmaceutical experience in designing/developing clinical studies.
  • Clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management / biostatistics processes and pharmacovigilance.
  • Experience working in or developing multidisciplinary teams to set up, and conduct clinical studies, preferable in the US and the EU.
  • Experience in a specialty pharma, rare disease or orphan indications and marketed products is highly desirable.

For further details email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701 or

087 6811990.   Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert