Principal Clinical Data Manager

JOB DESCRIPTION

The Clinical Data Manager (CDM) is responsible for clinical data management operations and activities such as data review (Query management, data listings review etc.) including external lab vendor and SAE reconciliations. CDM is also responsible for EDC testing, data cleaning, and ensuring compliance with regulatory data standards (CDISC, SDTM). The role requires proficiency in EDC Systems (like Medidata Rave, Oracle InForm, Veeva vault) and strong knowledge of clinical trial processes.

The CDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; understand the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

ESSENTIAL FUNCTIONS

• Support Internal Clinical Data Management Initiatives

• Complete assigned Data Management Operations/Activities under the direction of Study Lead or Line Manager

• Review CRF/eCRF data for completeness, accuracy, and consistency via system edits and manual data checks (data review listings)

• Generate and resolve queries in alignment with data management plans

• Contribute to Project Success by conducting duties per LDM/Study lead request

• Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System (Medidata Rave, Veeva EDC, Oracle InForm, etc.)

• Perform external vendor reconciliations (e.g., lab, imaging data)

• Perform SAE reconciliation

• Code data per selected coding dictionaries (e.g., MedDRA, WHO Drug)

• Participate in User Acceptance Testing (UAT) under supervision of the Study Lead

• Assist with data transfers, loading and integration

• Create and distribute metric reports for study tracking and performance insights

• Complete all required documentation per EDETEK and project requirements

• Manage allocated tasks with minimal oversight, ensuring deliverables meet quality standards and customer expectations

• Collaborate closely with EDC vendors, sites, and cross-functional study teams

• May serve as backup for study leads or lead simple studies independently

QUALIFICATIONS FOR ESSENTIAL FUNCTIONS

• Ability to communicate effectively in the English language in person, by phone and in writing

• Strong attention to detail and accuracy is a must

• Excellent organizational skills

• Ability to work collaboratively, effectively, and productively in diverse organization structures

• Ability to work in a team-oriented, collaborative environment

• Ability to work positively within a continually changing environment

• Ability to effectively prioritize and execute tasks in a high-pressure environment

• Familiarity with CDISC standards, GCP, and regulatory data compliance

• Demonstrated ability to work independently and lead study-level data operations

• Proven mentorship experience and ability to train junior staff

EDUCATION AND EXPERIENCE REQUIRED

• A bachelor's degree in life sciences is required

• A minimum of 5 years in Clinical industry

• A minimum of 2 years of core clinical data management experience is required

• Prior trial responsibility for the entire data management life-cycle is desirable

• Experience in specialty data functions such as coding, pharmacovigilance, or lab oversight

• Prior experience in external data vendor reconciliation and SAE reconciliation is required

• Prior experience of EDC UAT is preferred

• Must have exposure to studies in multiple therapeutic areas including Oncology

WORK REQUIREMENTS

• Corporate office environment or remote.

• Cross-functional interactions