Job description
Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
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
Qualifications
- Bachelor’s Degree or OUS equivalent required, degree in scientific field preferred; Associate’s Degree in Nursing with relevant experience also acceptable.
- Must have at least 4 years of Pharmaceutical industry-related experience.
- Demonstrated a high level of core and technical competencies.
- Exposure to study initiation through study completion is preferred.
- Possesses good written and verbal communication skills.
- Possesses analytical and critical thinking skills at operational and tactical levels.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
