Clinical Data Manager

Pharmavise Corporation; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid holidays

PTO (Paid Time Off)

Medical insurance

Job summary

Pharmavise Consulting Corporation is seeking a Clinical Data Manager for a remote role in the United States. You will oversee data integrity from collection through database lock, ensuring accuracy, consistency, and regulatory compliance across cross‑functional teams.

Responsibilities include CRF/EDC design, DMP development, data validation, and coordination with vendors. The ideal candidate has 3–5 years in CDM and strong knowledge of ICH‑GCP and CDISC standards.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 3–5 years in clinical data management in pharma/biotech/CRO.
• Proficiency in EDC platforms (Medidata Rave, Oracle InForm, Veeva, REDCap).
• Understanding of ICH-GCP, FDA, and CDISC standards.
• Strong organizational and communication skills.

Responsibilities

• Design and review CRFs and EDC systems to ensure accurate data capture.
• Develop and maintain data management plans (DMPs) and data validation specs.
• Oversee data cleaning and data queries with study teams.
• Perform ongoing data reviews to identify trends and deviations.
• Ensure adherence to CDISC standards and regulatory requirements.
• Manage database lock activities and CSR preparation.

Skills

Clinical data management

Data quality assurance

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Advanced degree a plus

Tools

Medidata Rave

Oracle InForm

Veeva

REDCap

Job description

This is a remote position. The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate, consistent, and meets regulatory and protocol‑specific requirements. This role collaborates closely with cross‑functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution.

Key Responsibilities

• Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol.
• Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines.
• Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams.
• Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations.
• Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP).
• Manage database lock activities and contribute to the preparation of clinical study reports (CSRs).
• Serve as the primary point of contact for data management vendors and oversee their deliverables.
• Participate in study team meetings and provide status updates related to data quality and timelines.
• Support audit readiness and participate in regulatory inspections when required.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field.
• Advanced degree is a plus.
• Minimum of 3–5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment.
• Proficiency in EDC platforms (e.g., Medidata Rave, OracleInForm, Veeva,REDCap).
• Strong understanding of ICH-GCP, FDA regulations, and CDISC standards.
• Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA,WHODrug).
• Excellent organizational, analytical, and problem‑solving skills.
• Strong communication and collaboration skills across cross‑functional teams.
• Experience working on global, multi‑site clinical trials preferred.

Benefits

In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well‑being.

• paid holidays
• Paid Time Off (PTO) policy
• medical insurance

We believe in fostering a healthy work‑life balance while providing the necessary support for professional and personal growth.

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E‑Verify Participation

Pharmavise Consulting Corporation participates in E‑Verify and will provide the federal government with your FormI‑9 information to confirm that you are authorized to work in the U.S. If E‑Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888‑897‑7781 or throughtheir website atdhs.gov/e‑verify.