Clinical Data Manager

Q2BI, Corp.; Cambridge (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

Q2BI, Corp. is seeking a motivated and detail-oriented Clinical Data Manager to join the CDM team. This entry-level role is ideal for candidates who understand clinical trials and want to build a long-term career in clinical data management.

You will assist with data collection, cleaning, and quality review for trials under supervision, gaining hands-on experience in a CRO setting that embraces modern data science practices and AI-powered tools.

Qualifications

• 1-2 years of experience in clinical trials.
• Bachelor's degree in a life science, health science, pharmacy, public health, or related field (may be waived for candidates with 5+ years of clinical trial industry experience).
• ICH-GCP certification.
• Ability to read and interpret clinical trial protocols.
• Exposure to Case Report Forms (CRFs) — either completing/filling out CRFs or supporting CRF design.
• Strong attention to detail, organizational, and time management skills.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective written and verbal communication skills.

Responsibilities

• Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs).
• Support database setup activities, including edit check specifications and user acceptance testing (UAT).
• Review incoming clinical data for completeness, consistency, and accuracy.
• Generate, track, and resolve data queries in collaboration with clinical sites.
• Maintain study documentation and data management files.
• Participate in cross-functional study team meetings and data review discussions.
• Support Serious Adverse Event (SAE) reconciliation and external data integration (e.g., labs, central imaging).
• Ensure data management activities follow SOPs, study protocols, and regulatory standards (e.g., ICH-GCP, CDISC).

Skills

Attention to detail

Time management

Effective communication

Learn technical systems

Education

Bachelor's degree in life/health sciences

Tools

EDC

CTMS

Microsoft Office

Job description

We are seeking a motivated and detail-oriented Clinical Data Manager to join our Clinical Data Management (CDM) team. This is an entry-level position ideal for candidates who understand the fundamentals of clinical trials and are looking to build a long-term career in clinical data management specifically.

In this role, you will assist with the oversight and coordination of data collection, cleaning, and quality review activities for clinical trials, working under the guidance of a senior team member. Clinical Data Management is a niche discipline that requires formal, hands-on training — all work in this role will be closely overseen as you build that expertise.

As a forward-thinking CRO, we are evolving our Clinical Data Management function to embrace modern data science practices, including interactive dashboards, analytics-driven trial oversight, and AI-powered tools to enhance data quality and efficiency. While this role is not directly responsible for building those tools, you'll be working alongside a team that is actively shaping the future of clinical data management.

KEY RESPONSIBILITIES

• Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs)
• Support database setup activities, including edit check specifications and user acceptance testing (UAT)
• Review incoming clinical data for completeness, consistency, and accuracy
• Generate, track, and resolve data queries in collaboration with clinical sites
• Maintain study documentation and data management files
• Participate in cross-functional study team meetings and data review discussions
• Support Serious Adverse Event (SAE) reconciliation and external data integration (e.g., labs, central imaging)
• Ensure data management activities follow SOPs, study protocols, and regulatory standards (e.g., ICH-GCP, CDISC)

QUALIFICATIONS

Required:

• 1-2 years of experience in clinical trials
• Bachelor's degree in a life science, health science, pharmacy, public health, or related field (may be waived for candidates with 5+ years of clinical trial industry experience)
• ICH-GCP certification
• Ability to read and interpret clinical trial protocols
• Exposure to Case Report Forms (CRFs) — either completing/filling out CRFs or supporting CRF design
• Strong attention to detail, organizational, and time management skills
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint)
• Effective written and verbal communication skills
• Ability to learn and apply technical systems and software (EDC, CTMS, etc.)

Preferred:

• Coursework or internship experience specifically in clinical data management
• Familiarity with EDC systems (e.g., Medidata Rave, Veeva Vault, Medrio, RedCap)

Q2BI, Corp. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.