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Clinical Project Leader

Eingestellt von Hays Resource Management - Astrazeneca

Projektbeschreibung

DESCRIPTION

A leading global pharmaceutical company are looking for a Clinical Project Leader to be based in Luton.

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with company Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

The Clinical Project Leader (CPL) is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

CPL can also perform tasks of a CRA.

MAJOR RESPONSIBILITIES

- Overall responsibility for the study commitments within the country, for timely delivery of data to required quality.
- Lead Local Study Team(s) consisting of monitors and study administrator(s).
- In collaboration with Line Manager(s),
- Lead and optimise the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
- Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
- Perform any required co-monitoring & QC visits with study monitor(s) - Proactively identify and facilitate resolution of complex study problems and issues.
- Contribute to patient recruitment strategy with monitors, including regular communication with concerned Investigators as necessary.
- Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
- In collaboration with the local study team, ensure completeness of the electronic Trial Master File and/or paper Trial Master File on country and site level, and ensure essential documents are sent to required locations.
- Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
- Provide input to process development and improvement.

Minimum Requirements and Preferred Background

- University degree or equivalent, preferred in biological science or healthcare-related field.
- A number of years proven experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
- Project Management experience across a range of therapy areas, ideally including one or more of oncology, cardiovascular, diabetes and respirator
- Fluent knowledge of spoken and written English.
- Good ability to learn and to adapt to work with IT systems.

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Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Hays Resource Management - Astrazeneca