Jazz Pharmaceuticals, Inc.
Location
United Kingdom | United States
Job description
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 TMF Manager demonstrates a good understanding of TMF processes and awareness of evolving regulatory requirements related to records management to support the development and delivery of a TMF Operations strategy. The TMF Manager is responsible for creating and updating tools and processes which will support clinical study teams across multiple functional areas to maintain a complete and contemporaneous TMF. The TMF Manager collaborates with a diverse set of stakeholders and leaders across various functions who utilize the TMF, whilst promoting TMF best practices.
Essential Functions
• Collaborates with multiple stakeholders and leaders across functions of relevant departments and additional eTMF users, as required to develop strategy for the study TMF, provides input to study risk assessment and vendor selection.
• Provides an advanced level of knowledge to cross functional TMF business representatives and/or Business Partners in TMF issue resolution.
• Drives and leads the development of study-specific, cross-departmental TMF Plans and TMF Indexes coordinating cross functional Jazz and CRO teams.
• Leads, develops and delivers high standard TMF process and eTMF system training
• Collaborates with Clinical Project Manager(s), TMF Operations Lead and other TMF Operations team members to develop study TMF oversight and TMF inspection readiness strategy.
• Leads and develops TMF process improvement and applies expertise to keep TMF current and industry leading.
• Executes TMF oversight at a global level by generating TMF-relevant metrics from the eTMF system and escalating any cross-organizational issues to functional leaders and study teams as necessary.
• Generates individual, departmental, and organizational performance metrics, escalates issues to TMF Operations Lead and departmental/organizational representatives as part of the TMF oversight.
• Promotes use of Jazz eTMF with cross functional teams including Managers, Senior Managers and partners, by building strong professional relationships and networks among peers and colleagues
• Supports Jazz eTMF business owner in system management to ensure compliance with all associated SOPS.
• Supports Jazz eTMF business owner in the role of eTMF business administrator, carrying out required eTMF activities including eTMF user access and requests for changes to TMF documents
• Supports TMF Operations Lead in development and execution of key performance indicators and key risk indicators as part of the study, organizational and global oversight
• Ability to act as deputy for TMF Operations Lead required, on TMF Ops related activities and tasks.
Required Knowledge, Skills, and Abilities
• Experience working in a TMF environment at a Sponsor or CRO company
• Extensive and current knowledge in Trial Master File Regulations, TMF Reference Model, and evolving industry standards and best practices
• Ability to show initiative to solve complex issues with regards to ways of working and bring innovative thinking to issues that arise
• Ability to work independently and work well in a global team environment to support overarching TMF Ops team deliverables
• Strong communication skills
• Ability to motivate others and drive decision making
• Attention to detail and methodical approach
• Flexible and adaptable to a fast-changing environment
• Excellent time management and organizational skills
• Strong track-record of developing TMF Plans and TMF Indexes
• Excellent computer skills (Microsoft Office suite, SharePoint use)
• Experienced working in an eTMF system (preferably Veeva Clinical Vault) as an end user, business, or system administrator
• Experience supporting Global GCP Regulatory inspections and internal audits
• Able to carry out responsibilities with minimal supervision
Required/Preferred Education and Licenses
• Bachelor’s Degree and 5 years’ experience in a Clinical Trials related functional area or 7 years’ experience in a Clinical Trials related functional area are required
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 $112,000-$147,000. 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
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 $120,000-$157,500. 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
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