Clinical Data Management Specialist
Actalent
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Benefits offered by this job
Job summary
Actalent is seeking a Clinical Data Manager to lead data management throughout the study lifecycle, ensuring data quality and regulatory compliance. You will design CRFs, manage data queries, and collaborate with cross-functional teams across trials.
The role requires 2–5 years in clinical data management, experience with EDC platforms (Medrio/Clinpal/Medidata Rave), and a CCDM or equivalent certification. Hybrid work in Libertyville, IL is offered.
Qualifications
- Bachelor's degree in Life Sciences, Clinical Research, Data Science, Healthcare, or related field.
- 2–5 years of clinical data management experience.
- Experience in medical device/pharmaceutical environments.
Responsibilities
- Lead CDM activities across the study lifecycle from protocol to database lock.
- Develop data management strategies aligned with study objectives and regulations.
- Collaborate with Clinical Operations, Project Management, Biostatistics and cross-functional teams.
- Develop and maintain DMPs, validation specs, monitoring guidelines, TMF deliverables.
- Lead CRF development and data collection strategies; support questionnaire design.
Skills
Education
Tools
Job description
Hours: Flexible start time between 7:00 AM and 9:00 AM based on business and meeting needs
- Lead clinical data management activities throughout the study lifecycle, from protocol development through database lock and archival.
- Develop data management strategies that align with study objectives and regulatory requirements.
- Collaborate closely with Clinical Operations, Clinical Project Management, Clinical Scientists, Biostatistics, and other cross-functional stakeholders.
- Participate in study team meetings and provide data management expertise throughout the conduct of clinical trials.
- Develop and maintain data management documentation, including:
- Data Management Plans (DMPs)
- Data validation specifications
- Monitoring guidelines
- User access documentation
- Trial Master File (TMF) deliverables
- Lead development and review of Case Report Forms (CRFs) and data collection strategies.
- Support questionnaire development and study-specific data collection requirements.
- Monitor clinical data and perform ongoing data review and cleaning activities.
- Manage data queries and resolve discrepancies in collaboration with study sites and investigators.
- Perform adverse event and data discrepancy reconciliations.
- Identify trends, risks, and quality concerns and communicate findings to study teams and leadership.
- Develop and maintain study metrics and provide routine status reporting.
- Design, configure, and maintain study databases within EDC platforms.
- Build and manage:
- CRFs
- Edit checks
- Data dictionaries
- User roles and permissions
- Automated queries and alerts
- Lead User Acceptance Testing (UAT) activities and validate database builds.
- Train internal teams and study personnel on study-specific EDC and ePRO systems.
- Oversee database cleaning, lock, export, and archival processes.
- Collaborate with CROs and external vendors supporting data management functions.
- Drive continuous improvement initiatives related to EDC systems and clinical data processes.
- Ensure all clinical data management activities comply with:
- Good Clinical Practice (GCP)
- Applicable regulatory requirements
- Internal SOPs and work instructions
- Support development and maintenance of departmental data management procedures.
- Participate in process improvement initiatives designed to enhance efficiency and data quality.
- Meet project timelines while maintaining exceptional quality standards.
- Bachelor's degree in Life Sciences, Clinical Research, Data Science, Healthcare, or a related discipline.
- 2-5 years of clinical data management experience.
- Minimum 2 years of clinical research experience within medical device and/or pharmaceutical environments.
- Minimum 2 years of data monitoring experience.
- Hands-on experience with Electronic Data Capture (EDC) systems such as:
- Medrio
- Clinpal
- Medidata Rave
- Similar platforms
- Strong understanding of:
- Clinical Data Management (CDM)
- Clinical trial operations
- Database design and maintenance
- Query management
- Data reconciliation
- Clinical research regulations
- Experience developing CRFs, questionnaires, and data management processes.
- Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Teams.
- Ability to manage multiple priorities while working independently with limited supervision.
- Certified Clinical Data Manager (CCDM) or equivalent certification.
- Experience with:
- User Acceptance Testing (UAT)
- ePRO platforms
- Medical device clinical trials
- CRO/vendor oversight
This is a Permanent position based out of Libertyville, IL.
The pay range for this position is $100000.00 - $125000.00/yr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.
This is a Permanent position based out of Libertyville, IL.
This position is anticipated to close on Nov 5, 2026.
This is a hybrid position in Libertyville,IL.
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
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