Senior Clinical Trial Manager
Senior Clinical Trial Manager
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Job Description
Description
Job Title:
Senior Clinical Trial Manager
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Clinical Operations
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 peoples 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 solutionoriented 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 peoples lives by delivering a new class of RNA therapeutics Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform Avidity demonstrated the firstever 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 inSan Diego CA.For more information about our AOC platform clinical development pipeline and people please visitand engage with us onLinkedInand X formerlyTwitter.
The Opportunity
This position manages 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.
What You Will Contribute
- Performs job with minimal supervision
- Acts as the clinical operations representative in a variety of crossfunctional 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 Kickoff 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 startup 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 studyspecific 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
- Bachelors 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
- 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 todevelop and maintain strong collaborative relationships with key internal and external stakeholders
- Ability to multitask well to deal well with conflict and obstacles and to work in a fastpaced environment
- Financial budgeting and forecasting skills
- In depth knowledge of ICH/GCP regulatory guidelines/directives and drug development and clinical research processes
- Team leadership experience within a crossfunctional matrix environment
- In depth knowledge of ICH/GCP regulatory guidelines/directives and drug development and clinical research processes
- Ability to travel if required including attendance at conferences site visits team meetings etc.
What We will Provide to You:
- The base salary range for this role is $171000 to $189000. 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 jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
#LIDNI
Required Experience:
Manager
Employment Type
Full-Time
