Clinical Data Management Leader (CDML) – Associate Director Level

Job title: Clinical Data Management Leader (CDML) – Associate Director Level

Job Description

Purpose of Job

The Clinical Data Management Leader (CDML) is responsible for leading and overseeing all clinical data management activities across assigned clinical studies and programs. This role ensures the delivery of high-quality, reliable, and regulatory-compliant clinical trial data to support study reporting, regulatory submissions, and decision-making. The CDML provides strategic leadership, manages cross-functional stakeholder relationships, drives process improvements, and mentors Clinical Data Management professionals.

Major Activities

Protocol development: Contribute to protocol synopsis, protocol and amendments from a data management perspective Be an active member of the clinical study team Trial start-up: Oversee development and review of data collection tools: (e)CRF, data transfer agreements, PROs, diaries Oversee development and review of data handling tools: data management plan, data validation plan, medical review listings, coding, SAE reconciliation plan, protocol deviations detection Ensure implementation of CDISC standards Trial conduct: Oversee data collection/review metrics, evaluate SDTM definitions and mapping, perform data content and structure QC Ensure inspection readiness and compliance with ICH-GCP, FDA regulations, EMA requirements, Data privacy regulations and Clinical trial industry standards Trial close-out: Lead database lock planning and execution Perform final QC on CRO deliverables Ensure completeness of data submission package Oversee transfer and archiving of the data management component of the Trial Master File Follow up on trial timelines and budget from trial start through close out and escalate issues, if required Support regulatory submissions (BLA, MAA,…) and ensure the data is prepared according to the regulatory requirements Support Head Data Management in the selection of DM Vendors and manage relationships with Vendors Lead/participate in initiatives on process improvements Participate in regulatory agency and internal audits

Key Performance Indicators

Timely setup of qualitative data collection tools Effective vendor oversight Timely delivery of scientifically sound clinical data, fit for statistical analysis, avoiding database reopenings Continuous process improvement achievements Successful inspections and audits

Key Job Competencies

Knowledge of ICH-GCP, EU and US regulatory requirements Knowledge of CDISC standards: SDTM and define.xml Knowledge of EDC platforms (e.g., Medidata Rave, Veeva EDC, …) Accuracy/Precision: data review needs to be meticulous High-quality standards: an eye for detail Strong problem solving and analytical skills Strong communication and interpersonal skills Able to work independently as well as in a team environment MS Office: proficient level Fluent in English, written and spoken

Job Background

Expected educational qualifications: BS or MSc in relevant field of life sciences or equivalent by experience Expected experience: 10+ years of Clinical Data Management experience within pharmaceutical, biotechnology, or CRO environments with at least 3 years in study leadership role

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter directly so that we can explore the appropriate arrangements.