Sr. Global Study Specialist

Employer
AbbVie
Location
Lake County, IL, US
Posted
Oct 24, 2018
Ref
1807876
Required Education
Bachelors Degree
Position Type
Full time
The role serves as a single point of accountability for the SMM study-level deliverables at global level and influences and aligns within Development Operations and other key stakeholders across the organization. Accountable for planning and driving global study-level SMM deliverables to completion by targeted timelines and within budget for their assigned studies. Serves as a primary SMM Point of Contact and interface for Study Team and SMM in their assigned studies. Accountable for management of complex and/or large single study or multiple studies, conducted in one or more countries.

Assists the Therapeutic Area Lead in strategic planning and driving timely completion of SMM deliverables at global level for the programs in their assigned TA(s)/indications, in alignment with key stakeholders across the organization.

Key Responsibilities Include :

  • Drives operational study-level strategy to be executed by SMM Country teams, including risk evaluation and mitigations to establish alignment with overall study planned timelines.
  • Accountable for working with each country LSR/Country/District COM to ensure LBEs fit within the overall study timelines and if not, establishing a risk mitigation plan for discussion with the study team. This occurs both at study start and on an ongoing basis.
  • Accountable for working across all countries - ensuring all participating countries are informed and aligned to the overall timelines for the study and receive appropriate info and docs.
  • Member of the Study Team, representing SMM globally. Attends study team meetings on planning and execution of the clinical programs. Provides Study Team with insights on SMM processes, communication/escalation paths and key contacts.
  • Identifies risks to SMM deliverables and effectively communicates them within SMM (global, area and regional level). Manages identified risk through development of effective mitigation and action plans at study-level. Works with Country Leaders and other functional areas, as appropriate to drive implementation of mitigation and action plans.
  • Partners with CPD, DDC and SMM Country leaders in developing overall study planning for SMM deliverables and dependencies, using analytics and country intelligence to enhance the Country and Site selection process. Ensures SMM Country leaders receive appropriate and timely study information, documentation and tools to allow for plans to be executed as per targeted milestones.
  • Accountable for the development of the study monitoring plan (SMP) and delivers SMP related training. Provides SMM insight on study-specific CRA training plans and training materials, site staff and patient facing materials. Delete
  • Responsible for coaching and mentoring Global Study Leads (GSLs) and providing input into their development.
  • Generates lessons learned at study level with appropriate stakeholders. Shares and implements best practices within SMM. Contributes to improving SMM efficiency, which may include participating in/leading Continuous Improvement Initiative(s). Leads change management in the adoption of new technologies and processes in the assigned studies conduct to support consistency and operational excellence in SMM overall execution.


Basic:

  • Bachelor's Degree or equivalent is required, typically in (para)medical or scientific field.
  • A minimum of 6 years + of industry clinical research experience including 2 years of monitoring or project management or equivalent experience on a global study.
  • Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Experience in multiple therapeutic areas or disease state/indications highly desired.
  • Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
  • Possesses good communication skills and demonstrated leadership abilities. Able to influence without authority in a matrix environment.
  • Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
  • Demonstrated good written and verbal communication skills including fluency in English. Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast-paced environment.
  • Able to work well within a team and autonomously, and thinks proactively.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled