Axogeniscommittedto building and maintaining a strong andgratifyingcompany culture that fosters a work-life balance and professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogenis the leadingcompany revolutionizing thescience of nerve repair.We arepassionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.
Contributetopositively impactinglives whileworkingfor a company that respects, recognizes, andvalues allteam members!
Axogenis an equal opportunity employer and does not discriminate against applicantson the basis ofrace, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Axogen is hiring for an Clinical Systems & Data Management Manager in Alachua or Tampa, FL!
Job Summary of the Clinical Systems & Data Management Manager
The Manager, Clinical Data Management leadsAxogen'sday-to-day data management activities by guiding the planning, oversight, and implementation of effective data collection tools and processes to support clinical research programs. In this role, the successful candidate will support existing data management partnerships while also building additional capabilities and competencies to address the needs ofAxogen'sexpanding clinical research programs. This involves working closely with study managers, CRO partners, and other stakeholders to identify data management needs, develop study specific data management plans, implement study databases, and establish best-in-class procedures forAxogen'sinternal clinical data management service. The Manager, Clinical Data Management will ensure compliance with applicable regulatory requirements, Good Clinical Practices (GCP), Good Data Practices (GDP), and industry standards.
Requirements of the Clinical Systems & Data Management Manager
Minimum of BS in Life Sciences or data sciences or equivalent combination of training and experience (advanced degree preferred)
Minimum of 5 years of experience in clinical research with at least 2 years of prior experience in clinical data management.
Knowledge of clinical trial methodologies, Good Clinical Practices (cGCP), Good Data Practices (cGDP), 21CFR11, CDASH and CDISC standards, and relevant regulatory requirements.
Extensive understanding of and prior experience configuring, testing, and maintaining Clinical Data Management Systems (CDMS). Experience withOpenClinicais preferred.
Demonstrated ability to operate and effectively lead within an environment of multiple lines of authority, building successful working relationships with stakeholders.
Prior experience in developing Case Report Forms and/or electronic Case Report Forms.
Demonstrated effectiveness in project planning, management, and critical problem solving.
Ability to be flexible and adapt quickly to needs of the organization.
Ability to organize multiple work assignments and prioritize effectively.
Excellent computer skills, verbal, and written communications skills.
Responsibilities of the Clinical Systems & Data Management Manager
The specific duties of the Clinical Systems & Data Management Manager include but are not limited to:
Providesguidance in the design and implementation of study specific data management plans.
Leadsday-to-day operations ofAxogen'sinternal clinical data management service.
Developsa best-in-class clinical data management program with effective and best-in-class internal and external capabilities and competencies.
Developsand implementseffective procedures to ensure compliance with applicable regulations, Good Clinical Practices, Good Data Practices, andAxogen
Qualifiesandimplementsa Clinical Data Management System (CDMS) which may include but is not limited to the following functionalities: Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO); Operational Reporting Dashboards and other related functions.
ManagesAxogen'sclinical data management personnel.
Programs/Configures/Validatesstudy specific Clinical Data Management Systems (CDMS) for internally managed studies.
Identifiesand drivescompletion of data management deliverables including but not limited to; developsCRFs; Configures/tests/launchesstudy specific CDMS; developsdata managementplans; performsdata entry (where applicable); performsdata cleaning/validation and query management, database lock; and data transfer.
Developsstandard operating procedures and standard templates to support data management activities.
Leadsthe development of a comprehensive approach to coordination, harmonization and oversight of data management activities across multiple platforms and vendors.
Identifiesrequirements for technology needed to enhance data management performance.
Ensuresaccountability for quality and timeliness of data management activities and ensuresstudy teams are adequately supported.
SupportsAxogen'scontinuous improvement initiatives and servesas data management subject matter expert to cross-functional clinical study teams.
Enablesa culture of excellence, inclusiveness, respect for diversity, and compliance.
