Onsite Clinical Data Manager: Lead DM Lifecycle & QA

Investigo; Princeton (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Investigo seeks a Clinical Data Manager to design, configure, test clinical database systems, conduct data review, and support study deliverables. The role interfaces with clinical study teams, CROs and vendors, and is on-site in Princeton, NJ.

You will lead data management lifecycle activities from study start-up through database lock, develop DMPs, CRFs, edit checks, data review plans, and oversee data cleaning. SAS and R programming experience are required.

Qualifications

• BA or BS with at least 4 years of relevant experience.
• Technologically savvy and quick to learn new standards and tools.
• Experience with Clinical EDC systems (Medidata Rave, Veeva EDC).
• SAS programming experience.
• Experience with Lab Data (PK, PD, Biomarkers).
• Detail-oriented with high quality output.
• Knowledge of GCP, CDISC (CDASH, SDTM, ADaM), FDA/ICH, GCDMP.
• Strong understanding of clinical research and drug development; oncology preferred.
• Knowledge of DM Lifecycle for P1-P3 studies.
• Knowledge of MedDRA and WHO Drug coding.
• Project management skills; manage multiple projects and deadlines.
• Strong interpersonal, organizational, and communication skills.
• Experience writing specification documents/work instructions.
• Experience with RTSM, eCOA/ePRO systems.

Responsibilities

• Leads all DM lifecycle activities from study start-up, maintenance, database lock and close-out.
• Develop DM documents (DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specs, data flow plans).
• Lead data cleaning activities and data reconciliation with cross-functional input.
• Manage data deliverables processes and database locks with high quality and efficiency.
• Foster collaboration with study team representatives (biostatisticians, PMs, CRAs, etc.).
• DM Project Management: lead and coordinate all DM activities to meet deliverables.
• Oversee data management work by vendors/CROs and assist in vendor selection.
• Perform MedDRA and WHO Drug coding coordination with CROs and medical monitors.
• Run SAS and/or R programs, review logs, and generate output.
• Evaluate CDM processes and participate in improvement projects.
• Participate in development of DM-specific SOPs.
• Oversee CRO data management activities and input integration.
• All other duties as assigned

Skills

Tech savviness

Project management

Attention to detail

Communication skills

Team collaboration

Education

Bachelor’s degree

Tools

Medidata Rave

Veeva EDC

SAS

R

Job description

Investigo seeks a Clinical Data Manager to design, configure, test clinical database systems, conduct data review, and support study deliverables. The role interfaces with clinical study teams, CROs and vendors, and is on-site in Princeton, NJ.

You will lead data management lifecycle activities from study start-up through database lock, develop DMPs, CRFs, edit checks, data review plans, and oversee data cleaning. SAS and R programming experience are required.