Avalo Therapeutics
Sr. Manager/ Associate Director, Data Management
Chesterbrook, PA · Director
Sponsorship not specifiedDetected 33 days ago
GCPStatisticsComplianceProject ManagementSAPProcess ImprovementHRICD-10PharmacologyFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationProblem SolvingBiostatisticsRegulatory Affairs
About the role
- Senior Manager / Associate Director, Clinical Data Management to provide leadership and oversight of clinical data management activities across one or more development programs.
- This individual will be responsible for ensuring the quality, integrity, timeliness, and regulatory compliance of clinical trial data from study start-up through database lock and submission readiness.
- Establish and monitor data quality metrics to ensure data accuracy, consistency, completeness, and readiness for analysis.
Responsibilities
- Lead clinical data management activities for assigned studies (especially for PK trials) from protocol development through database lock and submission readiness; Serve as the primary point of contact for CROs and vendors, ensuring data are delivered on time, within budget, and in compliance with ICH-GCP guidelines
- Develop and execute study-specific data management strategies to ensure high-quality, analyzable clinical trial data.
- Oversee and maintain Data Management Plans (DMPs), data review plans, and other study-level documentation.
- Develop and review database build specifications, edit check specifications, CRF completion guidelines, and validation plans.
- Lead User Acceptance Testing (UAT) activities and oversee database go-live readiness.
- Lead ongoing PK data and other data review, discrepancy management, query generation and resolution activities.
- Manage MedDRA and WHODrug coding activities and ensure consistency across studies.
- Support database lock activities and final data transfers for statistical analysis and regulatory submissions.
- Manage bioanalytical vendors for PK assay and ensure appropriate data collection to support PK clinical trial execution
Requirements
- 6+ years (if MS/MA degree) or 9+ years (if BS/BA degree) of clinical data management or relevant experience within the biotechnology, pharmaceutical, or CRO industry.
Nice to have
- MS/MA degree preferred.
- Experience leading data management activities from study start-up through database lock.
- Strong vendor and CRO oversight experience.
- Experience supporting regulatory submissions and inspection readiness activities.
- Management of PK trial data and clinical pharmacology experience highly desirable.
Skills
- Deep understanding of clinical data management principles, processes, and industry standards.
- Working knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, CDISC/CDASH, SDTM, MedDRA, and WHODrug.
- Experience with EDC systems such as Medidata Rave or equivalent platforms.
- Experience with drug development and PK sample collection.
- Strong understanding of external data integrations, reconciliation processes, and database lock procedures.
- Excellent project management, organizational, and problem-solving skills.
- Strong verbal and written communication skills with the ability to influence cross-functional stakeholders.
- Database Design, Build, and Validation
Benefits
- Collaborate with Clinical Development, Biostatistics, and Medical/Clinical Pharmacology teams to design and review electronic Case Report Forms (eCRFs).
- Oversee reconciliation activities including Serious Adverse Events (SAEs), laboratory data, medical coding, protocol deviations, and other external data sources.
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This listing is sourced directly from Avalo Therapeutics's careers page and normalized into a canonical job model.