Available Positions

Clinical Data Manager III at Pharmaceutical Company in Cary, North Carolina, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Cary, North Carolina, United States
  • 10/17/20

Job ID: 67045

Job Description

  • Lead study Data Manager for studies which are highly complex
  • Be accountable for all DM deliverables as assigned per the established timeline
  • Provide instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly
  • Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
  • Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings
  • Provide DM project team leadership and accountability
  • Lead data focused internal project team meetings
  • Meet frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates
  • Keep the Project Manager apprised of project progress
  • Maintain awareness of other deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary
  • Keep Project Manager, management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. budget status, work scope changes, timeline impacts).
  • Coordinate the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.
  • Develop and maintain client relationships and review client satisfaction surveys.
  • Implement appropriate action plans including driving process improvements and team training.
  • Apply corrective interventions where necessary to maintain project budget compliance and profit expectations.
  • Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed.
  • Provide leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
  • Coordinate with the DM Global Trainer and DM technology SMEs to coach and mentor study members on DM technologies and best practices for DM applications/tasks such as (EDC execution, SOP forms completion, tracking tools, reviewing vendor data in SAS Viewer, data listings creation, data cleaning).
  • Provide support to Data Management supervisors and managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards.
  • Accountable for learning new DM technologies and applied processes, keeping up-to-date with industry wide technology and feasibility for process improvement
  • Ensure service and quality meet agreed upon specifications per the DMP and scope of work.
  • Have input in writing, reviewing and updating SOPs and associated documents as required.
  • Maintain accurate records of all work undertaken.
  • Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate.
  • Utilize local laboratory systems and batch data load facilities where appropriate.
  • Represent Data Management and where necessary overall Biometrics in new business opportunities.
  • Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
  • Work with management team to develop and implement directional strategy by providing technical input into discussions and rolling out training/mentorship to DM staff as required.
  • Actively promote Biometrics services to sponsors whenever possible.
  • Perform other related duties as assigned by management.

Qualifications

  • University Degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
  • Knowledge of drug development process.
  • Knowledge of effective clinical data management practices.
  • In lieu of above requirement, approximately eight years’ experience in related field (e.g. pharmaceutical, laboratory, data analysis).
  • Eight years of combined early or late stage DM experience with four years of direct sponsor management and at least 2 years technical mentoring experience.
  • Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
  • Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
  • Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions.
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
  • Time management skill and ability to adhere to project productivity metrics and timelines.
  • Ability to work in a team environment and collaborate with peers.
  • Ability to mentor junior members of the department, providing SME guidance on Data Management practices
  • Experience of representing Data Management in bid defense meetings, providing innovative solutions to meet client needs.
  • Good organizational ability, communication and interpersonal skills.
  • Team working skills and good collaborator skills.
  • Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.

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