Clinical Data Manager

Mindlance; Woodcliff Lake (NJ); On-site; USD 90,000 - 110,000; Full time

Job summary

A leading financial client in Woodcliff Lake, NJ, is seeking a Clinical Data Manager to perform data management functions and oversee offshore CRO activities. The ideal candidate will have 3-5 years of experience in Clinical Data Management, particularly in the oncology field, with hands-on experience in EDC systems. Strong project management and communication skills are essential for this role, which offers a one-year extendable contract.

Qualifications

• Minimum 3-5 years’ experience in Clinical Data Management within pharma or CRO environment.
• Hands-on experience conducting all data management activities.
• Proficient in Oncology data management and regulations.

Responsibilities

• Perform data management functions for timely database lock for studies.
• Oversee offshore CRO for outsourced projects.
• Conduct data validation and medical coding.

Skills

Project management

Interpersonal skills

Data management activities

Oncology experience

Communication skills

Education

Bachelor degree in scientific or related field

Tools

EDC systems (Inform, RAVE)

I-Review/J-Review

Job description

Job Description

Title: Clinical Data Manager

Location: Woodcliff Lake, NJ

Duration: 1 year (Extendable contract)

Responsibilities

• Independently performs all data management functions to ensure timely and quality database lock for studies Phase I-III.
• Perform data management activities for EDC studies conducted in‑house as well as oversee activities of off‑shore CRO handling outsourced projects (protocol review, CRF development, database set‑up activities, data validation process; medical coding, SAE reconciliation, etc…).

Requirements

• Minimum 3‑5 years’ experience in Clinical Data Management within pharma or CRO environment.
• Bachelor degree or above in scientific or related field required. Commensurate experience in Data Management may be considered.
• Hands‑on experience conducting all DM activities and possess strong project management and excellent interpersonal skills to independently manage a global project.
• Must have experience with EDC, Inform preferred but open to other EDC such as RAVE, etc. Experience in some Oncology preferred.
• Knowledge of I‑Review/J‑Review a plus.
• Significant hands on experience when performing DM tasks, particularly with regards to general data review, discrepancy management and external data reconciliation.
• Oncology experience is a must, especially when dealing with Tumor reconciliation (RECIST 1.1, IrRECIST mRECIST etc…).
• Proficiency on all related regulations, GCP, and Good Clinical DM Practice.
• Computer proficiency and knowledge of medical terminology.
• Strong oral and written communication skills.

Additional Information

This job is with one of my Financial Client.