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 . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
The Study Project Manager I (SPM) connects science and operations to ensure excellence in management and execution of one or more Medical Affairs studies, including but not limited to, single and multi-country observational studies, as well as management and oversight of external research. The SPM II 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.
Responsibilities:
Responsible for planning, managing and executing Medical Affairs studies in compliance with quality standards (Global Regulations, AbbVie policies and procedures).
In partnership with Medical TA (Global, Affiliate, Area) and V&E team members, the SPM I is responsible for the development of the study protocol and associated documents (e.g., informed consent forms, case report forms, Clinical Study Report, publications).
Leader of the cross functional study team, including but not limited to, leading study team meetings, managing the critical path, working closely with Affiliates and ensuring study milestones are met.
In partnership with the Medical Affairs + Health Impact (MHI) study lead, responsible for the vendor selection, scope of the vendor activities and oversight of vendors in compliance with AbbVie processes and procedures and applicable regulations.
As applicable, responsible for generating study-related training for the study team members, study sites and selected vendors.
Responsible for regular updates to the cross-functional team (including Area/Affiliates, as appropriate) and other stakeholders (i.e. Evidence Planning & Execution Program EP&E Directors, MHI leadership) on study status; ensuring entries in the Clinical Trial Management System (CTMS) are complete and accurate and expected documents are filed in the Trial Master File (TMF).
Proactively identify and address and/or escalate study related issues; connect with TA-aligned EP&E Program Directors as needed.
Manages study budget and spend against approved budget; works closely with V&E Operations.
Contributes to and/or leads continuous improvement activities/projects and a team culture of information sharing and team building.
May provide direct supervision to AbbVie employees and/or oversight of contractors.
Qualifications
Bachelors Degree or international equivalent required, degree in scientific field preferred.
Must have at least 6 years of Pharmaceutical industry-related experience or equivalent, or 4 years of related experience with an advanced degree.
Competent in applying standard quality procedures (SOP, ICH/GCP, Local Regulations)
Demonstrates a high level of core and technical competencies through management of various components of clinical/medical studies.
Possesses good presentation and communication skills; demonstrates organizational, project management and leadership skills, with proven ability to successfully facilitate cross-functional team meetings.
Proven analytical and critical thinking skills at operational and tactical levels.
Operates with limited oversight; knows when it is necessary to escalate.
Demonstration of successful coaching/mentoring in a matrix environment
Experienced user of clinical trial systems (e.g., EDC, CTMS, eTMF) is preferred
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
-
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
-
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
-
This job is eligible to participate in our short-term incentiveprograms.
-
This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: