Job Description

Job Title:

Associate Director, Clinical Data Management

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA: Full time

Exempt

Department:

Clinical Operations

ID:

7525-Q224-21

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, 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.

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 database's accuracy, consistency, completeness, and high quality. The role will work closely with cross-functional 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 day-to-day 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 post-production 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; Maintain timely communication with both management and cross-functional 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 re-forecasting
• 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' hands-on 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 $180,000-$199,500. 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

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