Clinical Data Manager

I. Position Summary

The Senior Clinical Data Manager (CDM) is the Subject Matter Expert (SME) responsible for leading and executing all clinical data management activities from study startup through database lock. This role ensures all deliverables meet the highest standards of quality, are completed on time and within budget, and comply with all Standard Operating Procedures (SOPs), current industry, and regulatory guidelines (ICH, GCP, GCDMP). The CDM serves as the technical leader and primary contact for client and vendor communications.

II. Key Responsibilities

A. Study Leadership & Project Management

• Independently manage the end-to-end delivery of Data Management services for single and multi-service clinical trial projects.

• Serve as the primary liaison for internal teams, clients, and vendors, ensuring clear and effective communication throughout the study lifecycle.

• Guide and mentor junior members of the Data Management team, including supervising and scheduling Data Management Associates.

• Ensure data lock activities are performed according to agreed timelines, budget, and quality requirements.

B. Database Design & Setup (Design Phase Expertise)

• Serve as the technical expert for eCRF design, ensuring alignment with the study protocol and data management guidelines.

• Lead the execution of all study plans, from Data Management Plan (DMP) development through to database lock.

• Design, maintain, monitor, and lock databases for diverse trials, including Phase I (First-in-Human, PK/PD, SAD/MAD), Safety & Tolerability studies, utilizing various EDC systems.

• Apply in-depth knowledge of CDISC CDASH standards during database design and mapping.

C. Data Validation & Processing (Conduct Phase Expertise)

• Oversee all data entry, data cleaning, and data transfer activities.

• Implement and execute the Data Validation Plan (DVP) and create/maintain the Edit Check/Data Entry Guidelines (CCG/DEG) and Data Transfer Specifications (DTS).

• Develop and validate SAS programs for data validation, and the creation of CDISC SDTM, ADaM, and Define-XML datasets.

• Proactively identify and implement process improvements during study conduct (e.g., automating manual reconciliation processes like biomarker data checks) to improve efficiency and data quality.

D. Closeout & Submission Readiness

• Ensure all necessary activities are performed during the conduct phase to guarantee a smooth and timely database lock and closeout.

• Prepare and finalize data export files as required for statistical analysis and submission.

• Maintain audit-ready documentation and ensure complete traceability of all data management processes.

III. Required Qualifications & Skills

A. Experience

• Minimum of 5 years of progressive experience in Clinical Data Management, with demonstrated ability to independently manage entire studies.

• Proven experience working across all clinical trial phases, including Study Design, Conduct, and Closeout.

B. Technical Expertise

• Expert-level knowledge of all standard DM documents (DMP, DVP, CCG/DEG, DTS, Specs).

• In-depth working knowledge of major EDC systems and study building processes.

• Strong analytical, problem-solving, and technical skills in database programming (e.g., SQL, SAS).

• In-depth knowledge of CDISC CDASH standards and their practical application in eCRF design and database build.

• In-depth understanding of database structures.

C. Regulatory & Soft Skills

• In-depth knowledge of clinical trial processes, ICH, GCP, and GCDMP (SCDM) guidelines.

• Proven ability to provide leadership and think strategically to achieve business goals.

• Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines.

• Excellent written and verbal communication skills.