The Lead/Manager Clinical Data Manager (LDM) is responsible for all Clinical Data Management (CDM) activities
within the study assignment. The LDM brings project management skills to all task from study-start to final
database lock. This role leads and participates in cross-functional team meetings both internal and with external
collaborators to oversee and report on data activities. The LDM collaborates with cross-functional team members
such as Biometrics, CDM, Clinical Science, Medical Monitor, and Study Leads to identify and track key data risks
or trends and propose solutions. The LDM is accountable to ensure data activities are performed within scope of
applicable company and vendor SOPs, and regulatory agency guidelines.
Key responsibilities:
- 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.
Replimune, Inc., 500 Unicorn Park Drive, 3rd Floor, Woburn, MA 01801
- 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 Sponsorclinical data review activities.
Woburn Location: Local candidates are expected to be on-site 2 days per week. Non-local candidates open to 10-25% travel to Woburn office
Replimune is an equal opportunity employer.
Replimune now requires COVID vaccination disclosure for all US employees.