Job Details: Senior Clinical Project Manager, Pharma


JobsIreland
Jervis Street
Dublin 1
Senior Clinical Project Manager, Pharma


Our client, a growing pharmaceutical company with an exciting product
pipeline, now wish to hire a Senior Clinical Project Manager who will
be based in their Dublin office when not travelling. This is a
permanent role.

This hire must be willing and free to travel to clinical sites in EU,
America and worldwide, as required.

The Senior Clinical Project Manager will be the Sponsor and liaison;
responsible for planning, executing, managing and monitoring complex,
multinational clinical research projects).

The successful candidate will be experienced provide significant
operational input and oversight in planning; initiating, completing
and reporting clinical trials across a number of clinical trials.

RESPONSIBILITIES FOR SENIOR CLINICAL PROJECT MANAGER:

Contribute in external vendor qualification (eg CRO, eCRF, labs) and
selection related to clinical trials

Manage CRO and other external vendors supporting clinical studies

Participate to design, planning and execution of multiple phase I to
IV clinical trials to ICH GCP standards.

Draft, review and contribute to study related documents and regulatory
submissions.

Identifies risks and developing issues to senior management.

Provide input to both the CRO and ensure external study team adhere to
the plans such as Monitoring plan, Data Management Plan, Drug
Distribution and Reconciliation, Safety Plan.

Manage study timelines and report regularly to senior management on
clinical study progress and issues.

Maintain oversight of clinical trial data collection. Provide reports
to senior management.

Manage set-up and regular study meetings with vendors responsible for
clinical trial deliverables and data quality

Contribute to the development of study related documents (contracts,
ICFs, protocols, IBs, study plans, regulatory submissions for
Scientific Advice etc.)

Travel to clinical trial sites (global locations) to assess ICH-GCP
and protocol compliance and oversee clinical trial monitoring, data
quality.

Identifies risks and developing issues to senior management

REQUIREMENTS FOR SENIOR CLINICAL PROJECT MANAGER:

Bachelors Sciences Degree, MSc, PhD or other in Science or similar
discipline.

6 years’ experience as a Clinical Trial Project Manager either in a
CRO, Pharmaceutical, or Medical Device company.

Significant experience in managing large international multi-site
clinical studies.

Experience in clinical trial site monitoring

Experience in managing outside vendors, e.g., CROs, consultants and
other sub-contractors

Proefficient scientific/technical writing skill and experience such as
writing/contributing to ICF, IB, Protocols, SOPs, procedures, reports.

Strong knowledge and experience of clinical research operations,
including interpretation and implementation of FDA regulations/ICH
guidelines, is required

High level of skill with Excel, PowerPoint and MS Project or
equivalent

Excellent written and verbal communication skills required.

Travel (EU and US) as required.

For further details please phone LARRY ON +**APPLY ON THE
WEBSITE**-**APPLY ON THE WEBSITE** /

THE RFT GROUP , Biopharmaceutical Division specialise exclusively in
the recruitment of scientists, engineers and executives for the
biotechnology, pharmaceutical and medical device sectors.

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We need : English (Good)

Type: Permanent
Payment:
Category: Others

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