Remote Senior Clinical Data Manager
Job Description
R&D Partners is seeking to hire a Remote Senior Clinical Data Manager (East Coast).
Benefits of this role:
Competitive pay
Full-Time role
Benefits + 401k
Your main responsibilities as a Remote Senior Clinical Data Manager:
Responsible for the direct management and oversight of data management activities for assigned studies
Work in conjunction with the study team to ensure data review, project support, study document management and oversight of DM timelines, EDC/IWRS setup, study database design, clinical data capture, discrepancy management and data reconciliation
Primary point of contact between Data Management and the clinical team with respect to the management and oversight of data management activities
Author, review/revise Data Management related study plans including Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines and other study documents to ensure quality and standardization
Collect approvals and provide authorization on DM deliverables including but not limited to finalized DM documents, database release to production and database lock
Work with vendor(s) particularly to support the DM tasks such as transfer of data
Manage design and development of eCRFs, including database UAT
Review CRF annotations, data mapping/data conversion plan, review of SDTM datasets, etc.
Oversee and manage the development and implementation of edit check specifications and work with database programmers during programming and validation
Manage and oversee data management related activities for the ongoing study
Lead DM study meetings, distribute agenda, create minutes capturing action items, and decisions
Lead data reviews with clinical team to ensure accuracy, consistency, and reliability of data
Review database metrics and follow escalation process to achieve resolution of noted issues
Collaborate with study team to ensure study databases are locked based on pre-defined criteria and timelines
Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner
What we are looking for in a Remote Senior Clinical Data Manager:
Bachelor s Degree
Minimum 5+ years leading DM activities on multiple studies from study start up to database lock, and also be hands on for any DM tasks
Strong ability to lead several studies within a program and oversee a few lower-level DM staff
Vendor management experience
Main DM contact for cross-functional involvement and representation on study teams
Strong experience in Rave EDC
Why Choose R&D Partners?
Supportive teams
Ongoing contracts
Weekly payroll
Refer a Friend bonus
Pay Scale:
$73.60 $80 hour (Dependent on Experience)
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.