Senior Clinical Trial Manager

Initial Therapeutics, Inc.; Osage City (KS); Remote; USD 171,000 - 189,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Trial Manager to lead clinical study operations. This role involves managing CROs, developing project plans, and ensuring compliance with regulatory guidelines. The ideal candidate will have a strong background in clinical operations, excellent project management skills, and the ability to work collaboratively across functions. Join a dynamic team dedicated to improving lives through innovative RNA therapeutics. This is a fantastic opportunity to make a significant impact in a fast-paced and rewarding environment.

Benefits

Annual and spot bonuses

Stock options

401(k) with employer match

Comprehensive wellness program

Medical coverage

Dental coverage

Vision coverage

Four weeks of time off

Education reimbursement program

Qualifications

• 5+ years of experience in clinical operations required.
• Experience managing a CRO and complex studies is essential.

Responsibilities

• Manage overall clinical study operations including CRO and vendor management.
• Develop study operational plans and ensure compliance with GCP.

Skills

Clinical Operations

Project Management

Communication Skills

Analytical Skills

Attention to Detail

Team Leadership

Problem Solving

Education

Bachelor’s degree in Life Sciences

Tools

MS Excel

Smart Sheets

Job description

Job Title:

Senior Clinical Trial Manager

Location:

Remote

Position type:

Full time

FLSA:

Exempt

Department:

Clinical Operations

ID:

7525-Q224-1

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 Senior Clinical Trial Manager is a senior leader accountable for overall clinical study operations including CRO and vendor management, development of project plans, budget, and resource management. They will lead the development of study operational plans and provide input into other functional area plans and processes as needed. They will provide oversight of the CRO, vendors and sites as well as ensure compliance with GCP and regulatory guidelines. This position will work cross-functionally with clinical development, legal, finance, regulatory affairs, quality assurance, and IT, as needed.

What You Will Contribute

• Performs job with minimal supervision
• Acts as the clinical operations representative in a variety of cross-functional teams
• Collaborates with the program Clinical Operations Lead to develop and manage study level timelines and budgets in accordance with corporate, department, and project goals, working closely with internal leadership and CROs
• Independently manage clinical study vendors
• Establish key deliverables and KPIs in management of CRO and vendors
• Collaborate with CRO to identify and develop training needs for site staff, CRAs, and vendors specific to the study protocol and processes, including presenting these at Investigator Meetings and Kick-off meetings
• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments and CRO, as applicable
• Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
• Responsible for management and/or oversight of eTMF structure, plans and quality.
• Manage study activities including, but not limited to, investigator selection, drug supply projections, study start-up, subject recruitment & retention, data collection, and database locks, study drug accountability and study closeout.
• Actively contribute to technical and study design discussions, providing input toward clinical trial outlines, protocols, informed consent forms, and clinical study reports.
• Lead and/or collaborate with functional team members to draft/revise, finalize, and implement project plans, study-specific training, system builds, CRF designs, UATs.
• Identify issues and risks with cross functional teams and service providers; develop and present proposed solutions and provide oversight of timely resolution in a collaborative approach.
• Collaborate with data management (internal or CRO vendor) and CRAs to ensure data quality and compliance with data cleaning timelines
• May perform clinical data review of patient profiles, data listings and summary tables, including query generation
• Leads and/or contributes to department process improvements/initiatives and SOPs
• Provide direction and mentoring to junior team members.
• Escalate pertinent CRA performance and site compliance issues when necessary
• May have line management responsibilities
• Performs other duties as assigned by management

What We Seek

• Bachelor’s degree required, preferably in the Life Sciences or equivalent
• Minimum of 5+ years of experience in clinical operations is required
• Experience managing a CRO as well as a complex study in a previous Clinical Trial Manager (or equivalent) position is required
• Global Clinical Trial experience in Phase 2 and/or Phase 3 preferred
• Experience in Rare Disease or Neuromuscular drug development is a plus
• Inspection readiness and inspection experience is a plus
• Exceptional attention to detail and organizational skills
• Excellent communication (oral and written), analytical, and project management skills
• Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders
• Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment
• Ability to quickly learn and use technical applications with preferred experience using smart sheets/MS Excel or equivalent and the ability to manage budgets and forecast
• Prior auditing experience preferred
• Prior experience working as a Clinical Research Associate (CRA) preferred
• In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
• Team leadership experience within a cross-functional matrix environment
• Ability to travel for meetings and conferences nationally and globally, approximately 10%-15%

What We Will Provide To You

• The base salary range for this role is $171,000-$189,000. 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 include 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.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA 92121

O: 858-401-7900

F: 858-401-7901