Clinical Data Manager - Project Manager

Job Description

Company Description Hart Clinical Consultants (HCC) is a full-service Clinical Research Organization that supports global and US-focused clinical trials with comprehensive clinical and regulatory services. HCC provides staff augmentation and end-to-end study management across all phases of clinical trial operations, from phase I (first-in-human) through phase IV (post-market). The team is experienced operating under both 312 and 812 regulations and offers expertise in project and site management, study monitoring, data management, biostatistics, safety management, and technical writing. HCC also delivers specialized support for device training, innovative procedure proctoring, inspection preparedness, and operational oversight such as site payments and investigational device inventory management. For more information, visit

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Role Description - The Clinical Data Manager - Project Manager is a full-time remote position with the following responsibilities:

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• Lead all assigned data management activities independently across the full study lifecycle.

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• Design Case Report Forms (CRFs) based on the study protocol and collaborate with cross-functional team members and the sponsor to finalize and obtain approval.

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• Develop database requirements specifications, including visit schedules, edit checks, user roles and permissions, email alerts, and subject status definitions.

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• Establish EDC build and go-live timelines in partnership with the database developer and provide support throughout the build process.

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• Lead EDC User Acceptance Testing (UAT), including authoring test scripts, coordinating sponsor and cross-functional participation, and documenting findings.

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• Oversee internal validation activities prior to system go-live.

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• Present weekly data metrics at internal project team meetings and sponsor calls.

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• Monitor key performance indicators (KPIs) on a quarterly basis and develop mitigation plans when performance is at risk.

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• Develop and maintain core data management documentation, including the Data Management Plan, eCRF Completion Guidelines, Data Review Guidelines, and Coding Plan.

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• Deliver study-specific EDC training for internal team members, sponsors, and sites, as needed.

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• Perform ongoing data review, issue and track queries within the EDC system, and communicate data issues to internal stakeholders.

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• Manage EDC access for all users, including granting and revoking permissions as appropriate.

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• Establish and maintain timelines for data management deliverables throughout each project.

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• Serve as the primary data management point of contact for sponsors.

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• Conduct impact assessments for mid-study updates and manage related documentation and testing activities.

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• Participate in project kick-off meetings, bid defense meetings, and investigator meetings, as needed.

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• Prepare SDV status and query reports for CRAs in advance of monitoring visits.

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• Generate data extracts from the EDC system and provide them to the biostatistician for interim and final analyses.

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• Manage relationships with external vendors and prepare Data Transfer Agreements for external data file deliveries.

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• Perform SAE and laboratory data reconciliation activities.

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• Understand project scope and escalate out-of-scope requests to the Director of Biometrics, as appropriate.

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• Participate in audits as assigned.

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• Contribute to departmental process improvement initiatives.

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Qualifications

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• Bachelor’s degree in life science, nursing, computer science, or related discipline required.

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• Minimum of 10 years of clinical data management experience required, including at least 5 years serving as a Lead Data Manager.

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• Strong knowledge of EDC systems, iMednet and Medrio experience required.

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• Working knowledge of GCP, GCDMP, and ICH guidelines required.

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• Understanding of CDASH/CDISC standards required.

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• Experience in clinical data management within a pharmaceutical, medical device, or CRO environment required.

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• Experience across all phases of a clinical study, from start-up through submission, preferred.

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• CCDM certification preferred.

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• Excellent written and verbal communication skills, with the ability to work effectively in a global environment.

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• Strong time management and organizational skills, with an ability to multi-task and prioritize daily activities.

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• Exceptional attention to detail and accuracy.