AVP, Global Data Management & Standards

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply