Program Lead II, Data Management

16 hours ago

Chicago, Illinois, United States BioSpace, Inc. Full time
Job Details

Company Description

A leading biotechnology company, BioSpace, Inc., is seeking a highly skilled Program Lead II, Data Management, to join our team. As a key member of our Data Management team, you will be responsible for overseeing the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams, and physicians.

Responsibilities:
  • Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams, and physicians.
  • Oversee all EDC and IRT vendor contracts for assigned clinical trials.
  • Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trials.
  • Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials.
  • Lead clinical study team in the development of key clinical trial systems, study conduct, and study close-out as related to Data and Statistical Sciences (DSS) operational activities.
  • Create and manage Data Sciences communications plan for all assigned clinical trials.
  • Exercises real, but informal authority over Data Sciences study team members daily tasks and timelines.
  • Manages 4 to 7 clinical trial startups concurrently.
  • Plan and manage all Data Sciences timelines and deliverables for assigned clinical trials.
  • Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO), and Interactive Response Technology (IRT) vendors for assigned clinical trials.
  • Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events.
  • Manage any internal quality assurance audit for assigned clinical trials.
  • Aligns DSS study teams with program- and study-level strategies.
  • Assigned programs may include programs that are of low complexity and size.
  • For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team.
  • For assigned programs and studies, acts as single point of contact and accountable operational lead from DSS.
  • Coordinates associated DSS study teams to meet operational objectives.
  • Engages and connects global functional and cross-functional teams at the study level.
  • Interacts with and influences cross-functional team members to achieve program objectives.
  • Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to 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, AbbVie 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.
  • Participates as the DS study owner in regulatory inspections and internal quality audits.
  • 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.
  • Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives.
  • Conducts study execution lessons learned across functions.
Qualifications:
  • Bachelor's degree in business, management information systems, computer science, life sciences, or equivalent.
  • Masters preferred.
  • PMP Certification or Lean Six Sigma Green Belt desired.
  • Must have 6+ years of pharma/clinical research/data management/health care experience or 8+ years of project management experience (and/or applicable work experience).
  • In-depth understanding of clinical trial processes and clinical technology.
  • Management of a clinical trial from initiation through to completion in a lead role is preferred.
  • Rave experience.
  • Elluminate experience is preferred, but not required.
  • Demonstrated performance as a functional leader.
  • Demonstrated ability to influence others without direct authority.
  • Demonstrated ability to successfully coach/mentor in a matrix environment.
  • Demonstrated effective communication skills.
  • Demonstrated effective analytical skills.
  • Veeva and SpotFire experience preferred.

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