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Avalo Therapeutics · 1 day ago

Senior Manager, Data Management

Wayne, PA

Contract

Hybrid

Senior Level

5+ years exp

Avalo Therapeutics is a clinical stage biotechnology company focused on developing treatments for immune-mediated inflammatory diseases. The Senior Manager, Data Management is responsible for overseeing clinical data management activities, ensuring the quality and regulatory compliance of clinical trial data, and collaborating with various teams to support high-quality data delivery for decision-making and regulatory submissions.

BiotechnologyTherapeutics

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

Qualification

Data ManagementRegulatory ComplianceClinical TrialsMicrosoft OfficeECRF SystemsStatistical Analysis PlanProcess ImprovementCommunication SkillsAttention to DetailCollaboration SkillsProblem SolvingIndependent Work

Required

Bachelor's degree in related scientific or technical discipline

At least 5+ years' experience in data management in a pharmaceutical or CRO environment

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