Job Category: Pharmaceutical & Biotech

Clin Data Mgmt & Operations (DG)

Job Location: N/A, NJ (see all jobs in NJ)

Work Type: Remote

Date Posted: 2022-02-02

Clinical Data Management & Operations - Program Lead I or II

Remote - 10 Openings in multiple therapeutic areas that include Immunology, Oncology, Neuro, Aesthetics and others.

In this role, you will represent the Data and Statistical Sciences team as the Clinical Data strategy and Operations Program Lead within the cross-functional study team, aligning study teams with program and study-level strategies from the Clinical Data strategy and Operations perspective. Provides expertise on Data Management ensuring quality and timely delivery of all Clinical Data strategy and Operations Program Lead deliverables. For assigned programs and studies, the Clinical Data strategy and Operations Program Lead acts as single point of contact and is accountable for data management activities and timelines, collaborating with the cross-functional teams as needed. Responsible for ensuring the quality of all Clinical Data strategy and Operations Program Lead deliverables; working in conjunction with our clinical technology teams and external partners (clinical database development (EDC, IRT, eCOA), data quality review, trending, Data Management Plan, etc.). Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, track study progress, and prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development, as well as industry trends, data standards, and clinical technologies of importance for data management and contribute to enhancing capabilities and operational efficiencies. Participates as the Clinical Data strategy and Operations Program Lead study owner in regulatory inspections and internal quality audits. Conducts study execution. Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance. Responsible for coaching and mentoring team members, which may include indirect supervision of employee as well as supervising the work of contract resources. Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives.

FOR LEVEL I:
Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired. Must have at 2-3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and / or applicable work experience). Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred. Demonstrated effective leadership skills. Demonstrated ability to influence others without direct authority. Demonstrated effective communication skills. Demonstrated effective analytical skills.

FOR LEVEL II:
Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. 5-6+ years of data management / pharma or biotech / clinical research / health care experience. In-depth understanding of clinical trial processes and clinical technologies (EDC, IRT, eCOA), preferably RAVE. Working knowledge of electronic document management systems. Management of a clinical trial from initiation through to completion in a data management lead role. Understanding of ICH and GCP guidelines. Demonstrated performance as a functional leader. Demonstrated ability to influence others without direct authority. Demonstrated ability to successfully coach / mentor. Demonstrated effective communication skills. Demonstrated effective analytical skills.

NICE TO HAVE:
Master’s degree. PMP Certification or Lean Six Sigma Green Belt. Understanding of relevant regulatory requirements and CDISC Standards a plus.

Please contact Darren Gutowski at dgutowski@clarkdavis.com



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