Strive to Bring a Profound Difference to our Patients

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.

The Opportunity

The TMF Manager is responsible for supporting and overseeing the daily workflow of clinical operations TMF activities. The TMF Manager provides TMF-related support to study teams throughout the study.  Key activities include, but are not limited to, oversight of the study-specific eTMF, eTMF user management, eTMF training oversight, study-specific TMF Plan review and authoring, study-specific eTMF index or Configuration Manual review and authoring, study-specific Storyboard creation and maintenance, management of Required Document Lists and Events in study-specific eTMFs, creation and distribution of periodic study-specific eTMF metrics, study team follow-up regarding missing eTMF documents and open queries, periodic eTMF quality and completeness reviews and gap assessments, eTMF close-out and archival.

What You Will Contribute

• Serves as a member of the Clinical Operations team, providing support and oversight of TMF activities.
• Maintains effective communication with the study teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance, and close-out.
• Authors or reviews the study-specific TMF Plan and manages updates throughout the life of the study.
• Authors or reviews the study-specific eTMF index or Configuration Manual (CM) and manage updates throughout the life of the study.
• Leads the user management and training effort for the eTMF, confirming appropriate training and access for the various eTMF user roles and permissions.
• Attends department and study-specific meetings as required.
• Leads the set-up, maintenance, and close-out/archival of study-specific eTMF rooms.
• Supports the development of eTMF processes and plans as needed.
• Serves as the primary point of contact for study specific eTMF-related support.
• Distributes eTMF queries to the clinical study team and follows up until resolution.
• Performs quality and completeness reviews and gap assessments of the eTMF as per study milestones.
• Creates, distributes, and reviews metrics and ongoing status reporting on eTMF quality and completeness, aging queries, document rejections, document deletions, and expiring documents.
• Presents analysis and drives actions when identifying issues and trends; to include, follow-ups regarding missing documents, open queries, and expired documents.
• Collaborates with the clinical study team (internally, and with external CROs and vendors), to ensure that the eTMF is audit/inspection ready.
• Works with study teams to create and maintain Storyboards for all studies.
• Manages Required Document Lists and Events in eTMF for studies using these eTMF features.
• Performs ongoing best practice training, and provides feedback, and support to study teams to build knowledge and awareness of eTMF processes and system knowledge.
• May assist with eTMF audits and inspections, including preparation, any related requests, assist with resolutions, and sharing best practices from any final audit or inspection reports.
• May support system updates by participating in user acceptance testing, other change control related processes, reviewing release notes, and participating in system enhancement discussions.
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills, and maintain positive interactions with internal and external stakeholders.
• Communicates both verbally and in written form in an efficient and professional manner.

What We Seek

• Bachelor’s degree at a minimum or equivalent
• Minimum of 5+ years of clinical research experience
• Minimum of 2+ years of eTMF management experience

• Proficiency in Microsoft Office Suite
• Excellent organizational skills, attention to detail, and a customer service oriented
• Demonstrates a high level of knowledge of ICH/GCP, clinical research documents, their contents and purpose, and general clinical research processes.
• Possesses a high level of knowledge and experience utilizing an eTMF platform(s).
• Ability to communicate verbally and in written form in an efficient and professional manner.
• Collaborative team player, professional demeanor, enthusiastic, and self-motivated
• Ability to travel, including overnight stays if required

• Experience as a TMF Manager (preferred)
• Experience with Trial Interactive eTMF (preferred)
• Experience as an eTMF system administrator (preferred)
• Regulatory inspection experience (preferred)

What We will Provide to You:

• The base salary range for this role is $141,900 – $156,900. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.