Abcuro, Inc. is a clinical-stage biotechnology company developing protein-based treatments for serious autoimmune and cancer indications modulated by cytotoxic T and NK cells that express the inhibitory immune checkpoint receptor KLRG1 (killer cell lectin-like receptor G1). The company is advancing ulviprubart (ABC008), a first-in-class anti-KLRG1 antibody designed to deplete cytotoxic T cells that attack healthy muscle tissue in patients with inclusion body myositis (IBM) and TLGLL, into clinical studies.
POSITION SUMMARY
Abcuro, Inc. is seeking a Senior Clinical Data Manager. In this role the Senior Clinical Data Manager will lead and contribute to data management activities in support of Abcuro studies across all stages of clinical drug development. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and can perform all required tasks with minimal guidance. This position reports to the VP Research, Head of Data Management.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Lead Data Management activities as a program-level lead data manager in support of Abcuro clinical studies.
- Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing.
- Monitor data collection, coding, and cleaning by vendors through tracking of study metrics, internal data reviews and vendor key performance indicators.
- Provide oversight of database lock activities and ultimate archiving of study data.
- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, and Regulatory Affairs; CROs, central and local laboratories, and other vendors during the setup, conduct and closure of Abcuro clinical trials.
- Establish and participate in cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members. Performs or leads data reconciliation and other data quality assurance activities.
- Review, edit and approve CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation.
- Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.xml files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution.
- Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations.
- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.
- Mentor and train internal colleagues on data management activities and tasks as needed, fostering a collaborative environment of learning, growth and development. Participate in the training of external vendors and site staff.
- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met. Supports Abcuro New Drug Application (NDA) / Biologics License Application (BLA) activities.
- Review and edit clinical protocols/amendments, clinical study reports, statistical analysis plans, etc. Support regulatory filings including the writing and/or review of reports.
- Function as a leader for GCP inspection readiness activities for Data Management and serve as a primary point-of-contact for DM during inspections.
- Demonstrates alignment with Abcuro Core Values and Corporate Goals
EDUCATION AND WORK EXPERIENCE
- BA/BS Preferred in a scientific/health care field.
- At least 7 years’ experience in Data Management for the pharmaceutical/biotechnology industry as well as 4 years in a Lead Data Management role.
- Familiarity with EDC Clinical Data Management System as well as relational databases, SQL, and SAS. Should have experience with Medidata RAVE EDC.
- Experience working in clinical drug development through Phase 3 in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred
- Understands the scope and focus of clinical trials phase 1-3 and has a proven ability to perform the tasks, manage vendor resources and timelines.
- Possesses an in-depth understanding of regulatory guidelines e.g. ICH, GCDMP, 21 CFR 11 and their application to Data Management practice.
- Knowledge of and experience with MedDRA, WHODrug and other Thesaurus classification or controlled terminology systems.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Experience with NDA or BLA activities.
- Experience and understanding of the CNS therapeutic area is desirable.
- Able to travel to off-site meetings or training seminars as needed.
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards are desirable.
Abcuro believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of any legally protected status. Abcuro will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
**Please direct all inquiries and/or CV submissions to careers@abcuro.com