AVP, Global Data Management & Standards
USA - Pennsylvania - North Wales (Upper Gwynedd)
Job Description
The Associate Vice President, Global Data Management & Standards (GDMS) is responsible for ensuring that all clinical data management products and services are effectively delivered with high quality to meet the needs of our Research & Development organization's portfolio. The scope includes project and vendor management of data management deliverables, data integration, interactive voice response system (IVRS) services, ePRO services, pharmacovigilance case processing, data standards and platform governance.
Primary Responsibilities:
Ensures Clinical Data Management products and services are delivered to meet Research and Development (R&D portfolio needs. Includes: EDC System and associated technical architecture; ePRO and IVRS functionalities and PV case processing activities.
Sets vision and strategy for Global Data Management & Standards (GDMS)
Assess evolving needs and adapts appropriately by evaluation of new technologies, trends, and development in the industry.
Manage budget, headcount, and location strategies.
Contributes to the strategic vision and optimization of Global Clinical Trial Organization.
Education Requirements:
B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, Health Care, Computer Science or Engineering related discipline
Required Experience and Skills:
Minimum 15 years’ experience in Clinical Operations and/or Clinical Data Management (or related industry experience) including at least 10 years in a management position.
Ability to manage a large (>1000), global and diverse organization that has >65% flexible staff thru 3rd party partners.
Experience leading an organization that delivers against pre-established and benchmarked service level standards (quality, timeliness and productivity) for all deliverables and services.
Experience working with internal (Clinical Sciences, BARDS, GCTO, R&D IT) and external (functional service providers, labs, investigator sites, etc.) stakeholders to deliver products and services supporting a portfolio of clinical trials/programs across multiple therapeutic areas.
Experience leading/sponsoring process and/or technology-based innovation initiatives to maximize delivery of services with measurable outcomes.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Hybrid Hybrid work Hybrid work model On-site
Benefits/PerksBonus eligibility Diverse organization Diverse workplace Equal opportunity employer Flexible work arrangements Hybrid work Hybrid work model Inclusion Inclusive environment Insurance Meetings Paid holidays Retirement benefits Separation benefits package Sick Days Vacation
Tasks- Collaboration
- Data Management
- Governance
- Innovation
- Manage budget
Access Architecture Biological sciences Business Operations Clinical Clinical Data Management Clinical operations Clinical trials Collaboration Commercial Computer Computer Science Data Data Integration Data Management Data Standards Development Education Engineering Governance Inclusion Innovation Integration IT Law Management Manufacturing Medicine Nursing Operations Optimization Pharmacovigilance Pharmacy Project Management Quality R R&D Research Research and development Science Strategic vision Strategy Talent Acquisition Technical Technology Technology Innovation Therapeutic Areas Vendor Management
Experience15 years
EducationAS B.A. Biological Sciences B.S. B.S. degree Business Computer Science Engineering IT Management Pharmacy Related discipline Science Technology
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Europe/London Pacific/Honolulu UTC+0 UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9