- Functions as internal Data Management Study Lead, responsible for all data management activities performed by internal and external study team members to ensure data integrity, quality, and timeliness is protected.
- Works to ensure on-time achievement of CDM deliverables and milestones.
- Performs weekly review of clinical and vendor data metrics to ensure timely communication of significant data trends to the cross-functional study team and CROs.
- Provides presentations with MS PowerPoint slides during department and study meetings to describe study status, risks, successes, critical metrics, and necessary trainings.
- Proactively escalates critical issues and risks to the study and CDM leadership, tracking each item to a resolved state.
- Reviews and provides input into Protocol and other clinical study documents during development and through each amendment.
- Reviews and provides development input into all CRO generated CDM documentation, such as the Data Management Plan, CRF Completion Guidelines, Data Review Plan, Data Transfer Plans, Data Reconciliation Plans, and other similar files, before providing approval for distribution.
- Performs QC of CRO vendor data and SAE reconciliation to provide CRO feedback and negotiate timelines for resolution with the cross-functional process owner.
- Leads and participates in cross-functional data review activities.
- Executes Project Management and quality oversight for all EDC change management including Protocol Amendment change impact assessment, CRF specifications, Edit Check specifications, CRO QC and validation activities, Sponsor-UAT, and timeline management.
- Develops and manages the delivery of data report and listing specifications for data cleaning and Sponsor-clinical data review activities.
Educational and Experience/Skill Requirements:
- Bachelor’s degree in scientific/technical discipline is required.
- At least 5 years of CDM experience.
- A minimum of 1 year in Sponsor-level Oncology data management.
- Demonstrated experience in leading Oncology data deliverables to successful completion.
- Strong project management skills and ability to lead and collaborate effectively with cross-functional teams.
Replimune is an equal opportunity employer.
EEO & Employment Eligibility
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
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