Senior Trial Master File (Tmf) Specialist

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 of becoming a leading, fully integrated biotechnology company.

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.

SENIOR TRIAL MASTER FILE (TMF) SPECIALIST

The Senior Trial Master File (TMF) Specialist will provide primary support to ensure inspection readiness of Ionis Trial Master Files (TMF), reporting to the TMF Manager. The Sr TMF Specialist will deliver technical expertise in the Trial Master File (paper TMF & electronic TMF) management and will provide oversight of Ionis clinical trials throughout the lifecycle of the trial. The Sr TMF Specialist will support inspection readiness goals in compliance with ICH/GCP Guidelines, regulatory requirements, and internal policies. Additionally, the Sr TMF Specialist will be an integral addition to the advancement of in-house TMF activities and may also participate in the management of other, research quality-related documentation activities.

Position Summary / Key Deliverables:Monitoring and assessing the overall health of the TMF, ensuring quality, completeness, and timeliness in the eTMF, working with the clinical study teams and CROs. Subject Matter Expert for TMF/eTMF, spans across all research phases, collaborates with cross-functional, global clinical research studies throughout the lifecycle of the trials.

Position Responsibilities:Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and client policies as it relates to the completeness and accuracy of the TMF by ensuring the required documents reside in the TMF as per the Study-Specific Master TMF Plan and Master TMF Index and are inspection ready at all times.

• Work with study team to adhere to the TMF Plan and to update the Study Master TMF Index as appropriate
• Define expected documents for the study and maintain appropriate Expected Document Lists in the eTMF system in collaboration with Study team (study team serve as SME for their respective departments)
• Work proactively and prospectively with TMF Contributors at Study, Country and Site level to ensure timely uploading of all Essential Documents in the TMF
• Perform risk-based quality reviews of the TMF content by utilizing metrics and reports to assess any missing documents and then following-up with the appropriate functional group or document owner to mitigate, as per established review schedule
• Resolve noncompliance with overdue quality review findings and overdue In-Progress eTMF documents, which will improve the accuracy of the TMF
• Monitor and identify TMF trends and escalate concerns to management
• Generate, organize, and deliver on TMF performance metrics at the site, country, and study.
• At study completion, ensure the TMF is ready to be archived
• Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams
• Assist in overall change management and build collaborative relationships with cross-functional teams and third-party vendors
• Exhibit good project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines
• Display good time management skills, the ability to produce deliverables efficiently, meet timelines, and prioritize workload to meet business goals.
• Provide support to TMF implementation, internal audits and regulatory inspections
• Demonstrate ability to make decisions, deliver on commitments, share knowledge, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment

Degree Requirements:Minimum of Bachelor's degree in a scientific or related discipline

Experience Requirements:At least 3-5 years of TMF experience required, including experience in study start-up, maintenance and closeout, and performing quality and completeness reviews. Previous experience with independently managing and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.

• Must have 2 years of experience with Veeva Vault eTMF system and show advance proficiency with Window Office tools
• Must have knowledge of Core, Country, and Site level essential documents both domestically and internationally

Key Competency Requirements:Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (E6(R2))

• Very strong communication and interpersonal skills, verbal and written, is required
• Subject Matter Expert (SME) knowledge of clinical trial documentation, DIA Reference Model, clinical trial activities and related terminology

For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #IONIS003006

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 $85,000 to $116,250

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.