Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Senior Clinical Trial Specialist (SR CTS) supports moderately complex clinical trial activities in support of the Clinical Trial Manager. The SR CTS works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The SR CTS may assist with vendor oversight and management. They will identify issues in a timely manner and escalates to management as appropriate. The SR CTS may complete monitoring visit report review and perform co-monitoring. The core duties and responsibilities of the SR CTS are delineated below.
Manages Site Essential Documents review during study start-up, maintenance and close-out periodPrepares study documents and manuals (i.e. consent forms, site instructions, study specific material such as the Manual of Operations, Pharmacy binder, etc.)
Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management
Ensures tracking of patient status throughout the study at investigative sites
Review and approve trip reports, track data query reports, site visit metrics, and overall site performanceMay perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co- monitoring with local CRAs and CRO personnel.
Reviews data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
Assist in the preparation of, and may present at investigator vendor meetings and workshopsActively involved in organization of team and vendor meetings including preparation of agenda/ minute taking and updating any risk/ issue/ decision logs
Actively involved in the performance of study feasibility assessments Adheres to study timelines, quality, and budget for assigned studies
Provides rapid action to address both internal and site QA findings from auditsCoordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
Tracking and maintaining study status updates internally and externally Assist and support data query process
Routinely participates in department and clinical trial team meetings and participate in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)
Be able to work cross-functional with
Provides oversite of CRO and vendor activitiesReview and verification of contacted vendor activities including vendor invoice review
Bachelor’s degree preferred
5 or more years industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site management experience
Previous site monitoring experience is preferred
Clinical experience with the CNS therapeutic area is preferredWorking knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures Understanding of study phases and general knowledge of how they apply to clinical development Demonstrated ability to work independently and in a team environment
Advanced knowledge of Word, Excel, and PowerPoint. Strong verbal and written communication skills required. 15% - 20% travel may be required
Occasional mobility within office environment. Routinely sitting for extended periods of time.
Constantly operating a computer, printer, telephone and other similar office machinery.
Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
Frequent computer use at workstation.
May move from one work location to another occasionally.
Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
Occasional public contact requiring appropriate business apparel.