Senior Study Start-Up Specialist (Hiring Immediately)
Company: Jazz Pharmaceuticals
Location: Raleigh
Posted on: July 6, 2025
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Job Description:
If you are a current Jazz employee please apply via the Internal
Career site. Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and
epilepsy, and a growing portfolio of cancer treatments. Our
patient-focused and science-driven approach powers pioneering
research and development advancements across our robust pipeline of
innovative therapeutics in oncology and neuroscience. Jazz is
headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple
countries committed to serving patients worldwide. Please visit
www.jazzpharmaceuticals.com for more information. The Senior Study
Start-Up Specialist (SSUS) produces high-quality deliverables at
the country level for all clinical trial site activation
activities, leveraging project requirements and applicable country
rules to ensure effective outcomes. This role is essential to
ensuring investigator sites are prepared to start clinical trials
with emphasis on reducing site activation timelines, facilitating
rapid clinical trial start up, and collating and tracking of site
feasibility. With minimal oversight from the Study Start-Up
Manager, the SSUS works independently as well as collaboratively
with internal cross-functional partners (e.g., Clinical Operations,
Regulatory, Study Start-Up Specialists) and external stakeholders,
including contract vendors, on project-specific deliverables. The
SSUS ensures compliance and tracks milestone progress in agreed
upon SSUS tracking system in real time, analyzing data to provide
insight and rationale for forecasted timelines that are not
realized and delayed. If forecasted timelines are not realized and
delayed, the SSUS analyzes all relevant data to provide rationale
for and insights into delays, provides contingency plans to
mitigate impacts, and escalates issues as soon as identified. The
SSUS ensures continuous improvement of process and quality in all
Site Start-Up activities at the country level where assigned and
contributes to change initiatives across the SSU department. This
role may have line management and/or mentoring responsibilities for
junior staff. Essential Functions - Independently identify and
resolve minor to moderately complex site-related issues and risks
during the start-up process, including risks that can impact site
activation timelines. Escalate complex issues to Study Start-Up
leadership and Clinical Trial management as appropriate and
actively participate in their resolution. - Manage the preparation
and submission of ongoing regulatory documentation, including
amendments, periodic notifications required by central and local
IRB/Ethics Committee (EC) as needed within the country, and safety
reports and notifications, ensuring alignment with both local and
international regulatory requirements. - Collect and maintain
current Regulatory/Competent Authority (CA) and Ethics Committee
(EC) submission information within JVRIM/CTIS as well as similar
information for other related organizations for the assigned
country (e.g., IRAS). - Ensure Confidential Disclosure Agreements
are in place and clinical trial insurance is in place for
submission. - Collect and review initial regulatory packets and
site contracts for investigator sites, partnering with Regulatory,
Legal, Contractor Vendors, and Study Start-Up Leadership to secure
required authorization of these documents. Inform team members of
completion status of regulatory and contractual documents for
individual sites. - Obtain and maintain regulatory and ethics
approvals, review, and approval of essential documents for IP
release. - Inform team members of completion status of regulatory
and contractual documents for individual sites. - Apply knowledge
and judgment to influence continuous improvement efforts aligned
with organizational goals and regulatory standards. - Ensure all
relevant documents are submitted to the Trial Master File (TMF). -
Active involvement in the creation and development of start-up
plans and essential document checklists. - Manage SSU data tracking
entries, ensuring completeness and accuracy. - Review site
performance metrics and provide feedback to Study Start-Up Leader -
Active involvement with training within SSU department and updating
of SOPs/WI - Routinely participate in project meetings with
cross-functional department leads, providing updates on all site
activation activities. - The listed responsibilities and essential
functions are not exhaustive. The Company may assign other
responsibilities as needed. Required Knowledge, Skills, and
Abilities - Pharmaceutical or related industry experience,
including regulatory and study start-up experience and experience
with in-house trials/process design - Excellent knowledge of GCP
and regulations and Standard Operating Procedures - Adept at
understanding study phases and general knowledge of how they apply
to clinical development - Excellent ability to establish rapport
and build relationships with internal and external stakeholders at
all levels of seniority - Excellent attention to detail and
problem-solving skills - Ability to mentor, motivate, and lead
junior staff. Previous mentoring or people management experience is
helpful - Demonstrated ability to work independently as well as
collaboratively within a fast-paced, dynamic environment - Advanced
knowledge of Word, Excel, and PowerPoint Required/Preferred
Education and Licenses - Bachelor’s Degree or equivalent
combination of education, training, and experience. 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 full and complete base pay range is: $100,000.00 -
$150,000.00 Individual compensation paid within this range will
depend on many factors, including qualifications, skills, relevant
experience, job knowledge, and other pertinent factors. The goal is
to ensure fair and competitive compensation aligned with the
candidate's expertise and contributions, within the established pay
framework and our Total Compensation philosophy. Internal equity
considerations will also influence individual base pay decisions.
This range will be reviewed on a regular basis. 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.html.
Keywords: Jazz Pharmaceuticals, Raleigh , Senior Study Start-Up Specialist (Hiring Immediately), Science, Research & Development , Raleigh, North Carolina