Clinical Trial Specialist (Remote)

If you are a Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Brief Description:

The Clinical Trial Specialist (CTS) will be a member of the Jazz Pharmaceuticals Clinical Operations team.

They will have the following key responsibilities:

• Support moderately complex clinical study activities in support of the Clinical Trial Manager.
• Work closely with the Clinical Trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's.
• May assist with vendor oversight and management with guidance.
• Identify issues in a timely manner and escalate to management as appropriate.
• May complete monitoring visit report review and perform co-monitoring or monitoring oversight visits.

Essential Functions:

• Support Phase 1, 2, 3 and 4 clinical studies with guidance.

• Support activities related to study/site feasibility, start-up, maintenance, and close-out.
• Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out.
• With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable (including but not limited Informed Consent Forms, study manuals, site materials, training materials, pharmacy, and laboratory related manuals, etc.)
• Study Trial Master File (TMF) oversight.
  • Ensure required study documents received, reviewed, and filed in the TMF in accordance with SOPs, GCP and applicable regulations.
• Organize study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs.
• May lead and present at study related meetings.
• May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits).
• Provides rapid action to address both internal and site QA findings from audits.
• May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation.
• General study tracking and maintenance, includes but not limited to study status, enrolment, sites queries, deviations, study levels documents and plans, etc.
• Study site oversight including but not limited to site performance, metrics, monitoring report review, etc.
• Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
• Routinely support and participate in department and Clinical Trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.).
• Work cross-functionally and provide oversite of CRO and vendor activities, including vendor management as assigned.
• Review and verification of contracted vendor activities including vendor invoice review.
• Support study reporting and tracking with applicable systems and technology.
• Support study leads in cross-functional alignment of study timelines.

Required Knowledge, Skills, and Abilities:

• At least 2 years of experience (3yrs preferred) in clinical studies (Pharmaceutical Industry Experience Preferred).
• Previous site monitoring or study coordinator experience is preferred.
• Working knowledge of 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.
• Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).
• Knowledge of the principles and practices of computer applications in database management.
• Strong verbal and written communication skills required.
• 10% - 20% travel may be required.

Required/Preferred Education and Licenses:

• BA/BS, nursing degree or equivalent required, science major preferred.
• Relevant Clinical Trials experience is preferred.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US-BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $0-$0. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits