Job Description
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 +353 1-2302400 / larry@rftgroup.ie
The RFT Group, Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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