ICON plc

Associate Director, Clinical Data Manager

ICON plc

full-time

Posted on:

Location Type: Remote

Location: France

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Job Level

Senior

About the role

  • Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity.
  • Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution.
  • Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC).
  • Project management of all clinical data management related deliverables including operationalization by steering internal and external experts and specialist.
  • Ensuring adherence to planned time, cost and quality.
  • Execution of the clinical data collection strategy in accordance to Sponsor Standards.
  • Accountable for oversight of CROs in the execution of Phase I - IV clinical trial(s).
  • Represents Data Management within the Global Trial Team and serves as the key Global Development Operations point of contact for the DM related tasks in a trial/project/program.
  • Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams.
  • Drives, leads and manages the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills.
  • Ensures strong oversight, review and delivery of trial/project DM related CAPAs in order to meet corporate compliance standards and timelines.
  • Provides leadership and contributes to all operational aspects of the DM related trial budget, including forecasts to ensure delivery within the R&D financial standards.
  • Performs review and provides strong operational input in the development of Clinical Trial Protocols, Integrated Analyses Plan and CSRs.

Requirements

  • Advanced degree in Data Science, Statistics, Bioinformatics, or a related field.
  • Experience in all aspects of Data Management related clinical study planning and execution, and in executing the complete range of clinical study activities, from concept sheet through final study report and archiving.
  • Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to at least 10 years.
  • Substantial project management experience.
  • Strong leadership competencies and influencing skills.
  • Effective oral and written communication skills
  • Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
  • Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)
  • Successful completion of multiple studies from beginning to end providing a full scope of DM experience .
Benefits
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Data ManagementClinical Trial ManagementProject ManagementData Quality AssuranceCDISCClinical Database ManagementClinical Study PlanningClinical Trial Protocol DevelopmentIntegrated Analyses PlanClinical Study Report (CSR)
Soft Skills
LeadershipCommunicationOrganizational SkillsInfluencing SkillsTeam DynamicsPartnership BuildingProblem SolvingCollaborationAdaptabilityAttention to Detail
Certifications
Advanced Degree in Data ScienceAdvanced Degree in StatisticsAdvanced Degree in Bioinformatics