Associate Director Clinical Data Management
Associate Director Clinical Data Management
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Job Description
Description
Job Title:
Associate Director Clinical Data Management
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Clinical Operations
7525Q22421
Profoundly Improve Peoples lives by Revolutionizing the Delivery of RNA Therapeutics
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 visit www.aviditybiosciences and engage with us on LinkedIn and Twitter.
The Opportunity
Reporting to the Head of Clinical Data Management the Associate Director Clinical Data Management will be responsible for daily data management tasks for all phases of clinical trials including CRO/vendor oversight and support other functional areas such as clinical operations statistical programming and biostatistics. The Associate Director Data Management will ensure the clinical databases accuracy consistency completeness and high quality. The role will work closely with crossfunctional teams on the clinical development program health authority submissions presentations and publications across internal and external stakeholders.
What You Will Contribute
- Lead clinical data management oversight of outsourced clinical trials for Avidity clinical trials including project management vendor management coordination of internal reviews and approval of daytoday data management deliverables
- Assist Head of DM with setting up data management vendors as required including authoring of RFPs reviewing and negotiating data management budgets and contracts and liaising with study management CRO to ensure site training and timely initiation
- Provide direction and guidance to team members including vendors to achieve/meet corporate goals and milestones
- Oversee database design and postproduction updates ensuring that CROs vendors and internal staff meet the highest quality standards per the latest industry standard and regulatory authority requirements
- Responsible for client acceptance testing
- Oversee data management activities to maintain consistency across trials including development and implementation of data collection/review tools data management documents data flow metrics and driving data snapshot/closeout activities
- Proactively identify risks and execute risk mitigation strategies; Maintains timely communication with both management and crossfunctional teams
- Oversee CRO/Vendor activities to ensure GCP compliance Avidity quality expectations are met and timelines are adhered to
- Contribute to process development with focus on efficient streamlined procedures
- Contribute to program deliverable timeline creation and project reforecasting
- Support data management activities for regulatory submissions
- Performs additional duties as assigned
What We Seek
- BS degree in life science or related field with minimum of 6 years of CDM experience in CRO biotech or pharmaceutical industry
- A minimum of 2 years in biotech/pharma organizations and 6 years handson data management experience as a DM study lead
- Experience leading clinical studies from study start up to database lock and managing multiple programs and/or multiple studies within a program
- Strong vendor management and oversight experience including oversight of CRO partners eCOA central laboratory specialty lab and central readers
- Experience with inspection readiness activities and participation in mock/actual inspections
- Understanding of principles of clinical research ICH GCP (Good Clinical Practice) 21 CFR part 11 GCDMP (Good Clinical Data Management Practices) and related regulatory requirements
- Expertise with CDISC standards including CDASH and SDTM; Experience with resolution of Pinnacle21 output
- Proficiency with Medidata Rave EDC and other EDC platforms. Working knowledge of SAS or SQL preferred
- Proficient in Microsoft Word PowerPoint MS Project Outlook and SharePoint
- Experience in neuromuscular diseases or rare diseases preferred
- Experience supporting regulatory submissions and inspection readiness/inspection experience
- Ability to work well in a team environment both as a leader and a contributor
- Excellent communication skills (written and oral) across all organizational levels
- Collaborative respectful agile and transparent work style
What We Will Provide To You
The base salary range for this role is $180000$199500. 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 jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
Required Experience:
Director
Employment Type
Full-Time
