Job Specifications
***This position will initially be a 6-month contract position***
At Avalo (ahh-vah'-low), we’re 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process. We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.
Position Summary
The Senior Manager, Data Management (Contractor) is responsible for the clinical data management activities across one or more development programs. This role is responsible for ensuring the quality, integrity, timeliness, and regulatory compliance of clinical trial data from study start-up through database lock and submission readiness. Working in close collaboration with Clinical Operations, Medical, Biostatistics, Regulatory, IT, and external vendors/CROs, the contractor supports the delivery of high-quality data to enable sound decision-making and regulatory submissions.
Essential Responsibilities:
Consult on protocol development to ensure delivery of study data to support protocol objectives and endpoints
Oversee DM deliverables and timelines for clinical studies
Contribute to periodic data reviews with clinical study team to ensure sponsor oversight, and delivery of accurate, consistent and reliable data
Support database build during study start up, including review of EDC documentation and UAT activities, as well as database closure activities at study end
Participate in the development of study plans related to data delivery to ensure accurate and complete study data
Review RFP’s for clinical studies and collaborate on assessment of vendor qualifications, as applicable
Review vendor contracts to ensure delivery of required data components for submissions and/or audits
Facilitate data transfer agreements with external vendors and oversee reconciliation of third-party data
Support data reconciliation activities (e.g., Serious Adverse Events, Laboratory)
Provide input into statistical analysis plan (SAP) mock listings, and ensure there is an accurate reflection of data collection
Contribute to review of clinical study reports, including review of tables and listings for any inconsistencies with data management during course of studies.
Provide study data as needed by study teams to support study activities
Facilitate and manage dictionary (MedDRA, WHODRUG) coding activities and support protocol deviation review.
Review TMF documentation related to data management activities.
Education and Experience:
Bachelor’s degree in related scientific or technical discipline
At least 5+ years’ experience in data management in a pharmaceutical or CRO environment, small company experience a plus
ADDITIONAL SKILLS, KNOWLEDGE, AND/OR ABILITIES:
Excellent verbal and written communication skills
Highly organized with a strong attention to detail
Strong collaboration skills in working with external and internal cross-functional teams
Demonstrated proactive approach to problem solving with strong decision-making capability
Forward looking thinker, who seeks opportunities to improve processes
Ability to work independently
Highly proficient in Microsoft Office and eCRF systems
Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC CDASH standards, GCDMP, 21 CRF 11, MedDRA, WHO Drug), and their application to Data Management
Job Type: Contractor (6 months with potential to renew/convert)
Location: Hybrid; This role offers a flexible work arrangement but may require travel to corporate headquarters and attendance at customer-facing meetings, as needed.
About Avalo Therapeutics
Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com.
ATTENTION: External Agencies and Placement Firms
A member of the Avalo Human Resources Department will contact an agency directly if an open position is eligible to be sourced from an outside recruiting service. Avalo does not accept unsolicited resumes from employment agencies for any employment opportunity. All agencies/recruiters must have a written agreement/SOW in place with Avalo and prior to submitting any resume or CV.
All resumes must be submitted through the appropriate process. Any resumes submitted without an agreement an
About the Company
Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases.
For more information about Avalo, please visit www.avalotx.com.
Our highly targeted therapeutics have strong scientific and clinical rationale that enable accelerated clinical development and increased probability of success.
We are rapidly advancing a rich pipeline with broad clinical utility across Immunology, Immuno-oncology...
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