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Associate, Study Management III

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Full-time Remote 13d ago

Location:

Carolina Beach, NC, US

Company:

AbbVie is focused on discovering and delivering innovative medicines addressing critical health challenges across immunology, oncology, neuroscience, and eye care.

Summary:

The Associate, Study Management III role involves driving the process for Investigator Initiated Studies from intake through publication. Candidates should hold a Bachelor's Degree with at least 4 years of relevant pharmaceutical experience and possess strong communication skills.

Requirements:

Hard Skills: Core and technical competencies, Good written and verbal communication skills, Analytical and critical thinking skills at operational and tactical levels.

Credentials: Bachelor’s Degree or OUS equivalent required, degree in scientific field preferred; Associate’s Degree in Nursing with relevant experience also acceptable.

Experience: At least 4 years of Pharmaceutical industry-related experience., Exposure to study initiation through study completion is preferred.

Job Description:

The Study Management Associate (SMA) is responsible to drive and facilitate the end-to-end process for Investigator Initiated Studies (IIS) from intake through publication.

The SMA plays a key role in connecting functional areas both within Medical Affairs and Health Impact (TA BUs/Area/Affiliates) and across different R&D functions.

This role may also support the planning and execution of Medical Affairs studies, including single or multi-country interventional/non-interventional studies, post marketing observational studies, as well as external collaborations in partnership with Evidence Planning Director and/or Study Project Manager.

Responsibilities:

  • Support the Study Project Manager (SPM) in execution of study start-up, conduct and close-out of AbbVie Sponsored Research in compliance with quality standards (Global Regulations, AbbVie policies and procedures).
  • Supports in leading the cross-functional study team: preparing team meeting agendas/minutes, regular updates to the cross-functional team (including affiliates, as necessary) and stakeholders on study status; ensuring the Clinical Trial Management System (CTMS) are complete and accurate; expected study documents are filed in the Trial Master File (TMF) in a timely manner
  • Supports the development of the protocol
  • Supports the development of associated systems (e.g., EDC and/or eCOA) and documents (e.g., Informed Consent Forms, Case Report Forms, Data Management Plan, Clinical Study Report, Publications, etc.)
  • Supports vendor selection, defining scope of activities, and oversight all vendors in compliance with AbbVie’s process and procedures
  • Supports the management of investigational product and other associated study supplies
  • Supports generation of study related training for the study team members, study sites and selected vendors
  • Remotely conducts routine monitoring of study data, identifying study-level issues and/or trends; recommends mitigations
  • Support selection, activation, and maintenance of US sites.
  • Project manages externally sponsored research (e.g., investigator initiated studies and/or external collaborations) in compliance with quality standards (Global Regulations, AbbVie policies and procedures).
  • Liaise with Sponsor Investigator or affiliates on operational aspects of the study (e.g., enrollment updates, milestone payments, supply of AbbVie product, protocol amendments, etc.)
  • Responsible for MHI stakeholder management, raising risks and mitigations as appropriate.
  • Contributes to a team culture of information sharing, team building, and mentoring of junior staff.
  • Ensures inspection readiness and participate in related inspection/audit activities

This is a remote position