Act as the single point of accountability for data management deliverables at an assigned level within a given clinical development program
Serve as Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to DM
Manage system integrations across data platforms
Ensure CRO and third-party data review outputs are reviewed according to agreed plans and filed in the Trial Master Plan as appropriate
Perform ongoing data review of clinical data to identify data discrepancies, general data trends, and corresponding resolutions as part of oversight over the CROs
Review data for protocol deviation identification, dictionary coding, and perform user acceptance testing of database
Review documents produced by vendors and other departments
Create data management process documents such as data management plans, data review specifications, data transfer agreements, diagram workflows, timelines and communication plans
Work cross-functionally with other departments within the company assessing and understanding their needs
Strategize and plan for database locks and multiple deliverables across numerous studies within a program ensuring consistency in process
Provide input on the development of standard operating procedures (SOPs) and study protocols from a data management perspective
Provide guidance to clinical data management personnel on assigned projects
Set-up, maintain and archive data management related project documentation (i.e., Data Management Plan, CRF Completion Guidelines, etc.)
Independently monitor own activities and project status for successful project deliverables according to timelines
Adhere to budgets and timelines
Ensure project is in reasonable state of inspection readiness and compliance

Requirements

Bachelor’s degree in life science, pharmacy or related field
Equivalent combination of education and applicable job experience may be considered
6 years of direct Data Management experience required
Prior clinical trial vendor management and integration experience a must
Demonstrated knowledge of drug development and Clinical Data Management processes
Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
Understanding of ICH Guidelines and GCP Requirements
Excellent communication skills and interpersonal skills
Well-versed in different EDC Systems; preferred proficiency in Medidata RAVE
Experience in managing outsourced studies and/or leading CRO data management teams
Experience in leading data integrations using EDC, IRT, ePRO and external laboratory processing and vendor reconciliation
Experience in solving complex and increasingly difficult problems
Ability to leverage Artificial Intelligence Models to support evolving data efficiencies is preferred
Ability to develop and maintain timelines
Understanding of dictionary coding (i.e. MedDRA and WHODrug)
Self-motivated and can independently manage responsibilities with minimal supervision
Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets)
Ability to travel as necessary (approximately 10%)

Benefits

premium health
financial, work-life and well-being offerings for eligible employees and dependents
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Data ManagementClinical Data ManagementCDASHSDTMdictionary codingproject managementdata reviewuser acceptance testingdata integrationproblem solving

Soft Skills

communication skillsinterpersonal skillsself-motivatedorganizational skillsleadership skillscross-functional collaborationstrategic planningoversightindependent managementbudget adherence