Clinical Data Standards Manager | Pharma | CDISC | SDTM | RAVE | CRO Experience

Aequor; Basking Ridge (NJ); Hybrid; USD 100,000 - 130,000; Full time

Job summary

A leading clinical research organization located in Basking Ridge, NJ is looking for a Manager for Clinical Data Standards. The role involves developing and sustaining global clinical data standards crucial for quality submissions. This manager will work with diverse teams to optimize data collection and ensure compliance with industry standards. The position requires a minimum of 5 years of experience, a Bachelor's Degree in life sciences, and a strong understanding of the RAVE system and SDTM. A hybrid in-office presence is expected.

Qualifications

• 5+ years of experience in relevant roles, preferably in CRO or pharma.
• Strong expertise in clinical data standards and SDTM.
• Experience in data collection methods including EDC.

Responsibilities

• Manage development and sustainability of Global Clinical Data Standards.
• Collaborate with cross-functional stakeholders to optimize data collection.
• Ensure alignment with industry standards for health regulations.

Skills

CRO/pharma working background

Minimum 5 years of experience

RAVE system knowledge

SDTM knowledge and experience

Strong communication and presentation skills

Education

Bachelor's Degree or higher in life sciences or related field

Tools

RAVE

Job description

Job Title

Manager, Clinical Data Standards

Location

Basking Ridge, NJ 07920

Duration

Contract till Nov 2026 with possibility to extend

Checklist

• This opening is to cover for someone on maternity leave
• We're looking for someone local and able to come onsite as needed (hybrid)
• RAVE system (library build and management, development of edit checks)
• SDTM
• clinical data standards

Job Schedule

Local and able to come onsite as needed - maximum of 2 hours commute round trip.

Job Summary

The Manager, Clinical Data Standards, is responsible for the development and sustainability of the Global Clinical Data Standards for quality submissions and success of the client R&D pipeline by managing activities associated with standards development, management, and implementations for client Therapeutic areas. This position provides expertise within Data Management by partnering with diverse cross functional stakeholders to optimize data collection services for client Programs. The position will also help in defining standards collection and mapping data definitions thereby ensuring alignment with industry (CDISC) standards for Health Authority regulations. Working knowledge of various data types, data collection methods (EDC & Non-EDC), and direct experience implementing industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, etc.) for data submissions and relative processes is a must.

Demonstrated ability to self-start, be solution-oriented with an innovative spirit, and be accountable for results by working in a fast-paced environment are some of the requirements of this role. Leading-edge skills in clinical data standards, expertise in Study Data Tabulation Model (SDTM), excellent verbal/written skills, analytical, and interpersonal skills for working effectively with people at different levels are also some of the requirements of this role. The Manager, Clinical Data Standards should be a subject matter expert in clinical data standards as it relates to developing clinical data collection tools.

Skills

• CRO/pharma working background
• Minimum 5 years of experience
• Working hands on knowledge of RAVE system, library build and management. Development of edit checks in RAVE
• SDTM knowledge and working experience
• Team player who can interact and operate with a cross functional team. Strong communication and presentation skills required.

Education

Bachelor's Degree or higher in life sciences or related field required