A Clinical Trials Manager is required for a biopharmaceutical company in Dublin City Centre. The successful candidate will work with the Clinical Program Manager to manage global clinical trials or regional components of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.
- Manages global studies and/or regional components of global Phases II-III outsourced studies managed by a Clinical Program Manager.
- Independently manages all components of a small less complex clinical study.
- Manages cross functional timelines and maintains the study timelines.
- Contributes to the development of the study budget.
- Manages vendors, including CROs.
- Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
- Assists in determining the activities to support a project’s priorities within a functional area.
- Drafts and coordinates review of relevant documents including protocols, Informed Consents, Case Report Forms, monitoring plans, Investigator Brochures and Clinical Study Reports.
- Must be able to understand, interpret and explain protocol requirements to others.
- Coordinates review of data listings and preparation of interim/final Clinical Study Reports.
- Contributes to development of RFPs and participates in selection of CROs/vendors.
- In collaboration with data management, develops and participates in review of clinical study data and other metrics to ensure data integrity.
- Responsible for filing necessary documents in the electronic trial master file (TMF), and provide oversight for regular cross-functional reviews of the TMF.
- May be asked to train CROs, vendors, investigators and study coordinators on study requirements.
- May serve as a resource for others within the company for clinical trials management expertise.
- Participate in departmental or interdepartmental strategic initiatives under limited supervision.
- May contribute to development of abstracts, presentations and manuscripts.
- Supports the professional development and mentoring of Clinical Trial Manager Associates.
- May conduct oversight monitoring visits, as required.
Qualifications & Experience:
- B.Sc. or B.A. in a relevant scientific discipline or RN qualification.
- At least five years relevant clinical trial experience in the pharmaceutical industry.
- Demonstrates an ability to manage studies or programs of higher complexity from both a process and strategic perspective.
- Demonstrates an ability to interact with contacts cross-functionally at senior levels within the Company.
- Able to examine functional issues from an organisational perspective.
- Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organisational perspective.
- Must have a general, functional expertise to support SOP development and implementation.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
- Working knowledge and experience with Word, PowerPoint and Excel.
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