Senior Clinical Data Manager - Remote, End-to-End CDM

princeps technologies; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Princeps Technologies is seeking a Senior Clinical Data Manager to own data management across the full clinical trial lifecycle, from start-up through close-out. This remote role welcomes candidates based in the USA or Canada and requires hands-on CDM expertise and ability to work independently.

You will design eCRFs, manage data quality, oversee CROs, ensure regulatory compliance, and mentor junior staff as part of a cross-functional team.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 8+ years in hands-on clinical data management in pharma/biotech/CRO.
• Experience across study start-up, conduct, and close-out.
• Strong knowledge of major EDC systems (Medidata Rave, InForm/Clinical One, Veeva CDMS).
• Familiarity with CDISC standards (CDASH, SDTM) and MedDRA/WHO Drug dictionaries.
• Excellent written and verbal communication; detail-oriented.
• Ability to work independently in a remote setting.

Responsibilities

• Study Start-up: Develop DMP, CRF guidelines, data validation specs; design/edit eCRFs; set data transfer specs.
• Study Conduct: Data cleaning, query management, SAE reconciliation, coding using MedDRA/WHO Drug; manage CHANGE requests.
• Study Close-out: Lead database lock, interim/final locks, SDTM/CDISC deliverables, TMF filing, post-lock queries.
• Across All Phases: Ensure ICH-GCP, Health Canada, FDA, EMA compliance; mentor junior data managers; drive process improvements.

Skills

Clinical data management

EDC systems

Regulatory knowledge (ICH-GCP)

CDISC standards (CDASH, SDTM)

Documentation & communication

Independent remote work

Education

Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing, Computer Science, or related field

Tools

Medidata Rave

Oracle InForm/Clinical One

Veeva CDMS

SAS

R

JReview

Spotfire

Job description

Princeps Technologies is seeking a Senior Clinical Data Manager to own data management across the full clinical trial lifecycle, from start-up through close-out. This remote role welcomes candidates based in the USA or Canada and requires hands-on CDM expertise and ability to work independently.

You will design eCRFs, manage data quality, oversee CROs, ensure regulatory compliance, and mentor junior staff as part of a cross-functional team.