Position OverviewA clinical-stage biotechnology company is seeking an experienced
Senior Clinical Data Manager Consultant to support its growing clinical development organization.
The Senior Clinical Data Manager will be responsible for the oversight, coordination, and execution of clinical data management activities across one or more clinical trials. This individual will play a key role in developing and executing clinical data strategies that support high-quality, regulatory-compliant data deliverables.
The ideal candidate will bring significant
sponsor-side clinical data management and vendor/CRO oversight experience, along with strong hands-on expertise with
Medidata Rave.
This is a senior-level position requiring the ability to independently manage complex data management activities, identify and resolve issues, and effectively collaborate with Clinical Operations, Biostatistics, Statistical Programming, and other cross-functional stakeholders.
Key Responsibilities- Lead Clinical Data Management activities across assigned clinical trials from study start-up through database lock.
- Develop and oversee eCRFs, eCRF completion guidelines, Data Management Plans (DMPs), data review guidelines, edit check specifications, and other study-specific data management documentation.
- Design, review, and finalize case report forms (CRFs) in collaboration with cross-functional team members.
- Oversee the implementation and maintenance of study-specific clinical data management systems and processes.
- Lead and oversee database development, validation, user acceptance testing (UAT), and go-live activities.
- Develop and execute plans for the processing, review, and cleaning of clinical trial data within established timelines and budgets.
- Monitor clinical data flow and ensure timely, accurate, and high-quality data availability for analysis.
- Identify data quality issues and work with internal teams and external partners to drive timely resolution.
- Provide strong sponsor oversight of CROs, data management vendors, and other external partners responsible for outsourced data management activities.
- Establish and monitor vendor performance, timelines, deliverables, and data quality expectations.
- Review clinical protocols and Statistical Analysis Plans (SAPs) to ensure alignment with data collection and management requirements.
- Ensure clinical data management activities comply with applicable SOPs, ICH-GCP, regulatory requirements, and industry standards.
- Represent Clinical Data Management in cross-functional study team meetings.
- Communicate project status, risks, issues, and proposed resolutions to project teams and leadership.
- Provide recommendations regarding clinical data management processes, systems, and study-specific challenges.
- Contribute to the continued development and improvement of data management processes, standards, and tools.
- Monitor study-related data management budgets and evaluate vendor change orders and potential cost overruns.
- Support audits and regulatory inspections and contribute to corrective and preventive action (CAPA) activities when required.
- Train and mentor junior team members and promote clinical data management best practices.
- Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Regulatory, and other functional stakeholders.
Required Experience & Qualifications- Bachelor's degree in a scientific, clinical, life sciences, or related discipline.
- Minimum of 10 years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
- Strong sponsor-side experience, including direct oversight of CROs and external data management vendors.
- Extensive experience leading Clinical Data Management activities across the full clinical trial lifecycle, from study start-up through database lock.
- Strong Medidata Rave experience required.
- Expert knowledge of Electronic Data Capture (EDC) systems; experience with platforms such as Medidata Rave and Veeva.
- Significant experience with database design, development, validation, and user acceptance testing.
- Strong understanding of CDISC standards, including CDASH and SDTM.
- Strong knowledge of ICH-GCP, FDA requirements, and other applicable clinical trial regulations and guidelines.
- Expert understanding of clinical trial processes, clinical data flow, data review, and data cleaning best practices.
- Demonstrated experience managing CROs, vendors, and global clinical study teams.
- Proven ability to lead data management activities for complex and/or global clinical trials.
- Ability to independently identify and resolve complex data management and technical issues.
- Strong project management, organizational, and prioritization skills.
- Excellent written and verbal communication skills.
- Ability to effectively influence cross-functional stakeholders and senior leadership.
- Ability to manage multiple priorities and studies within a fast-paced clinical development environment.
Key Candidate ProfileThe strongest candidates will combine
deep clinical data management expertise with significant sponsor-side oversight experience. Candidates should be comfortable operating independently, managing CRO and vendor deliverables, and serving as the Clinical Data Management subject matter expert within a cross-functional study team.
Medidata Rave expertise and strong sponsor oversight experience are critical requirements for this position. 
