TMF System Manager
Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.
TMF SYSTEM MANAGER
CORE RESPONSIBILITIES
- Administer and oversee Veeva eTMF and the Master Data Management (MDM) system
- Primary contact for escalated TMF-system support issues
- In collaboration with the Project Team(s), ensure high quality TMF setup (design and build out of the study TMF, onboarding of study users, design of reports and dashboards, proper integrations, etc.)
- Conduct training of the Veeva and MDM Systems to internal and external stakeholders
- Prepare regular metrics and status reports for Clinical Operations, Clinical Development, and Quality Assurance review
- Work with the Project Team(s) to map clinical documents and data transfers
- Import the CRO(s) or partner(s) mapped documents and data into the TMF in a timely and controlled manner
- Work together with the different business areas to implement new features
- Help the different business areas define and manage requirements and implement them internally or with Managed Services
- Work with the vendor for any major issues/bugs in the application
- Coordinate with the vendor for Veeva product releases
- Provide support to clinical teams during regulatory inspections for data organization and retrieval
COMPETENCIES IDENTIFIED FOR SUCCESS
- Outstanding organizational skills with the ability to multi‐task and prioritize in a fast-pace environment
- Excellent attention to accuracy and details
- Effective written and verbal communication skills
- Solid analytical and proactive problem‐solving skills
- Strong operational skills and demonstrated ability to meet timelines
- A team player with strong interpersonal skills; ability to resolve dynamic tensions
- Flexible to an ever‐changing environment
- Demonstrated self‐starter with a high level of commitment
- Ability to learn new technologies with ease
Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS003177
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $62,594 to $90,665.
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
From the moment of our founding we knew that we could transform the biopharmaceutical industry. We had the right people, the right science, and the unwavering commitment to bring about a new approach to drug discovery and development that would de...
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