Clinical Data Management Leader (CDML) - Associate Director Level

Reference: 631076Posted: 2026-09-18Location: New York, New YorkCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io of JobThe 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 ActivitiesProtocol development: Contribute to protocol synopsis, protocol and amendments from a data management perspectiveBe an active member of the clinical study teamTrial start-up: Oversee development and review of data collection tools: (e)CRF, data transfer agreements, PRO’s, 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 standardsTrial conduct: Oversee data collection/review metrics, evaluate SDTM definitions and mapping, perform data content and structure QCEnsure inspection readiness and compliance with ICH-GCP, FDA regulations, EMA requirements, Data privacy regulations and Clinical trial industry standardsTrial close-out: Lead database lock planning and executionPerform final QC on CRO deliverablesEnsure completeness of data submission package Oversee transfer and archiving f 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 requiredSupport 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 improvementsParticipate in regulatory agency and internal auditsKey Performance IndicatorsTimely setup of qualitative data collection tools Effective vendor oversight Timely delivery of scientifically sound clinical data, fit for statistical analysis, avoiding database reopeningsContinuous process improvement achievementsSuccessful inspections and auditsKey Job CompetenciesKnowledge of ICH-GCP, EU and US regulatory requirementsKnowledge of CDISC standards: SDTM and define.xmlKnowledge of EDC platforms (e.g., Medidata Rave, Veeva EDC, …)Accuracy/Precision: data review needs to be meticulousHigh-quality standards: an eye for detailStrong problem solving and analytical skills Strong communication and interpersonal skills Able to work independently as well as in a team environment MS Office: proficient levelFluent in English, written and spoken Job BackgroundExpected educational qualifications: BS or MSc in relevant field of life sciences or equivalent by experienceExpected experience: 10+ years of Clinical Data Management experience within pharmaceutical, biotechnology, or CRO environments with at least 3 years in study leadership role