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(K) Clinical Data Manager (1337)
Ref No.: 18-27723
Location: Malvern, Pennsylvania
Project Leader /Senior Project Leader, Data Management

Primary purpose and function of this position:
  • Ensures data management activities and deliverables for area(s) of responsibility are completed in line with business requirements and company objectives.
  • Oversees service providers to perform core data management functions including CRF, edit check development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures.
  • Evaluates and makes recommendations related to inter- and intra-departmental processes in order to identify and implement efficiencies and quality improvement measures.

Major duties and responsibilities:
  • Leads and manages DM tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.
  • Executes according to the DM Outsourcing and related strategies and processes, developing positive partnerships with CROs and ensuring a high standard of deliverables is maintained.
  • Serves as the DM focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
  • Supports collaboration, communication, coordination and prioritization within the department working in conjunction with Data Management Programming Lead.
  • Participates and contributes to local and global departmental activities, projects and tasks, in close collaboration with Strategic Planning.
  • Represents Data Management and facilitates project related integration with other groups, notably Clinical Research, Clinical Programming, Statistics, CQA and Regulatory.
  • Approves Data Management Plans for completeness and accuracy of required documentation according to SOP.
  • Provides input into CDMS requirements, assuring protocol requirements are met. Oversees and performs UAT on CDMS components as needed.
  • Acquires knowledge related to drug development, clinical trials methodology, and applies the relevant information in recommending changes in data management to better satisfy business requirements.
  • Supports validation efforts to minimize the company's exposure to regulatory risk by validating all electronic data streams and systems in support of organizational objectives.
  • Follows Safety, Health, and Environmental policies and procedures.
  • Conducts other projects and tasks as assigned.

Education and Knowledge Requirements:
  • Project Leader require at least three years (Senior Project Leader, five years) of data management experience in a pharmaceutical or clinical research setting. Bachelor's Degree or higher, or equivalent amount of combined educational and work experience is required. Exceptional candidates may be considered with less years depending on experience and education.
  • Experience in directly managing/overseeing service providers is desired.
  • Experience with computerized clinical data management systems.
  • Thorough understanding of the drug development process, clinical trial methodology, GCP regulations, and data management principles.
  • Strong and effective oral and written communication skills and interpersonal skills.
  • CCDM is preferred.
  • Knowledge of SAS and database programming, systems integration experience and understanding of CDASH and CDISC standards are preferred.
  • Ability to work in a virtual, global and multi-cultural environment.