Hybrid Clinical Data Manager — Oncology Trials Lead

Systimmune; Princeton (NJ); Hybrid; USD 100,000 - 170,000; Full time

Benefits offered by this job

Health benefits (medical)

Dental and vision

STD/LTD

401(k) with company match

Paid time off

11 paid holidays

Job summary

SystImmune is seeking a Clinical Data Manager (CDM) in Princeton, NJ for a hybrid role requiring onsite presence 3 days per week. The CDM will design, configure, and test clinical databases, perform data review, manage data delivery, and oversee CRO/vendor activities to ensure study deliverables are met on time.

Responsibilities include DM document development, data cleaning, data locks, and collaboration across cross-functional teams of biostatistics, pharmacology, and regulatory affairs.

Qualifications

• BA or BS and a minimum of 4 years of relevant experience.
• Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC).
• SAS programming experience.
• Experience with managing Lab Data, such as PK, PD, and Biomarkers.
• Detail-oriented; performs quality and accurate work.
• Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and GCDMP.

Responsibilities

• Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
• Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans.
• Independently lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation.
• Manage data deliverables processes and database locks, with high quality and efficiency.
• Foster collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Scientists, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics Scientists, Medical Writers, Regulatory representatives, etc.).
• DM Project Management: With oversight, ensure data management deliverables are met on time.
• Utilize communication, metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities.
• Manage/coordinate work performed by vendors/CROs to ensure quality of product.
• Perform Medical Coding as needed, works with CROs, Medical Monitors, and Clinical Scientists to coordinate activities for the medical review of clinical trial data.
• Run SAS and/or R programs, review SAS and/or R logs, troubleshoot errors, and generate output.
• Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications.
• Participation in development of DM specific SOPs.
• Oversight of CRO data management activities and integrating the various functional group input.

Skills

Data management

SAS programming

R programming

Vendor management

DM lifecycle

EDC systems

Biotech/clinical trials

Communication

Education

BA or BS in life sciences or related

Tools

Medidata Rave

Veeva EDC

RTSM

Job description

SystImmune is seeking a Clinical Data Manager (CDM) in Princeton, NJ for a hybrid role requiring onsite presence 3 days per week. The CDM will design, configure, and test clinical databases, perform data review, manage data delivery, and oversee CRO/vendor activities to ensure study deliverables are met on time.

Responsibilities include DM document development, data cleaning, data locks, and collaboration across cross-functional teams of biostatistics, pharmacology, and regulatory affairs.