Clinical Data Analyst

WhiteCap Search; Bridgewater (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

WhiteCap Search is seeking a dedicated Data Management professional to support assigned DM studies in Bridgewater, NJ, ensuring GCP compliance and data quality.

Responsibilities include updating DMPs and CRF guidelines, reviewing EDC discrepancies, running study metrics, and reconciling external data to the clinical database. Strong collaboration and attention to detail are required.

2+ years in biotech/pharma/CRO data management with Associates degree or higher preferred.

Qualifications

• Hands-on experience with Electronic Data Capture systems (Medidata Rave desired).
• Excellent communication skills (verbal and written).
• Experienced working in a cross-functional team environment.
• Strong organizational skills.

Responsibilities

• Facilitate updating Data Management Documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, and CRF Completion Guidelines per Lead DM expectations.
• Verify external vendor test data per specifications document.
• Run and review outputs and database study metrics.
• Participate in data reviews.
• Review discrepancies in the Electronic Data Capture (EDC) system, monitor/facilitate resolution, and close out or re-query per study guidelines. Note and communicate trends to clinical trial manager(s) for follow-up.
• Reconcile external data to the clinical study database and perform Serious Adverse Event reconciliation.
• Ensure Data Management procedures and processes are adhered to in a consistent manner.
• Provide high-quality services through efficient and compliant processes.

Skills

EDC systems

Communication skills

Cross-functional team

Organizational skills

Education

Associates Degree or higher

Tools

Medidata Rave

Job description

Join our team in Bridgewater, NJ. We are looking for a dedicated professional to perform activities for assigned studies in support of DM study lead in compliance with company processes, Good Clinical Practice (GCP), and regulations. This role is pivotal in ensuring the integrity and quality of clinical data.

• Facilitate updating Data Management Documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, and CRF Completion Guidelines per Lead DM expectations.
• Run and review outputs and database study metrics.
• Review discrepancies in the Electronic Data Capture (EDC) system, monitor/facilitate resolution, and close out or re-query per study guidelines. Note and communicate trends to clinical trial manager(s) for follow-up.
• Reconcile external data to the clinical study database and perform Serious Adverse Event reconciliation.
• Ensure Data Management procedures and processes are adhered to in a consistent manner.
• Provide high-quality services through efficient and compliant processes.

Join our team in Bridgewater, NJ. We are looking for a dedicated professional to perform activities for assigned studies in support of DM study lead in compliance with company processes, Good Clinical Practice (GCP), and regulations. This role is pivotal in ensuring the integrity and quality of clinical data.

Responsibilities (Essential Role Responsibilities):

• Facilitate updating Data Management Documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, and CRF Completion Guidelines per Lead DM expectations.
• Verify external vendor test data per specifications document.
• Run and review outputs and database study metrics.
• Participate in data reviews.
• Review discrepancies in the Electronic Data Capture (EDC) system, monitor/facilitate resolution, and close out or re-query per study guidelines. Note and communicate trends to clinical trial manager(s) for follow-up.
• Reconcile external data to the clinical study database and perform Serious Adverse Event reconciliation.
• Ensure Data Management procedures and processes are adhered to in a consistent manner.
• Provide high-quality services through efficient and compliant processes.

Skills

• Hands-on experience with Electronic Data Capture systems (Medidata Rave desired).
• Excellent communication skills (verbal and written).
• Experienced working in a cross-functional team environment.
• Strong organizational skills.

Education

• Minimally 2 years of clinical data management experience in a biotech, pharmaceutical, or CRO environment is preferred.
• Associates Degree or higher is required.

Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.