Clinical Data Management Leader (CDML) – Associate Director Level

Planet Pharma; New York (NY); On-site; USD 160,000 - 220,000; Full time

Job summary

Planet Pharma in New York, NY is seeking a Clinical Data Management Leader to oversee data management across multiple studies, delivering high-quality, regulatory-compliant data for submissions and decision-making.

The role provides strategic leadership, mentors data management professionals, and drives process improvements while collaborating with cross-functional teams to meet timelines and budgets in a fast-paced environment.

Qualifications

• BS or MSc in life sciences or equivalent by experience.
• 10+ years of Clinical Data Management experience in pharma, biotech or CRO settings.
• 3+ years in a study leadership or cross-functional leadership role.

Responsibilities

• Lead and oversee clinical data management activities across studies and programs.
• Ensure delivery of regulatory-compliant, high-quality data for submissions and decision-making.
• Oversee data collection and data handling tool development, eCRF design, data validation and SDTM mapping.

Skills

ICH-GCP knowledge

CDISC standards

EDC platforms

Attention to detail

Analytical skills

Problem solving

Communication skills

Independence

MS Office

English fluency

Education

BS or MSc in life sciences

Tools

Medidata Rave

Veeva EDC

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, 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 standards
• Trial conduct:
  • Oversee data collection/review metrics, evaluate SDTM definitions and mapping, perform data content and structure QC
  • Ensure inspectionreadiness 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 f the data management component of the Trial Master File.
• Follow up on trial timelines and budget from trial start through close out and elevate 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