Study Project Manager I

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.

The Study Project Manager (SPM) is responsible to connect science and operations to bring studies to life through the planning and execution of one or more Medical Affairs studies, including multi-country/US only non-interventional studies, post-marketing observational studies, as well as management and oversight of external collaborations. The SPM achieves these objectives via scientific and operational expertise.

Responsibilities:

· Responsible for planning and executing Medical Affairs studies in compliance with quality standards (Global Regulations, AbbVie policies and procedures).

· In partnership with the TA BU/Scientific Director, the SPM is responsible for the development of the study protocol and associated documents (i.e., 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.

· Responsible for the vendor selection, scope of the vendor activities and oversight of vendors in compliance with AbbVie processes and procedures and applicable regulations.

· Responsible for generating the study related training for the study team members, study sites and selected vendors.

· Responsible for regular updates to the cross-functional team and stakeholders (including affiliates) 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.

· Manages study budget and spend against approved budget.

· 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.

· Bachelor’s Degree or OUS equivalent required, degree in scientific field preferred.

· Must have at least 6 years of demonstrated pharma-related and/or clinical research related experience or equivalent or 4 years with 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 studies.

· Possesses good presentation and communication skills; demonstrates strong 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 independently with limited oversight; knows when it is necessary to escalate.

· Demonstration of successful coaching/mentoring in a matrix environment

· Exposure in study initiation through study completion is preferred.

· Experienced user of clinical trial systems (e.g., EDC, CTMS, eTMF) is preferred

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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. ​

• This job is eligible to participate in our long-term incentive programs​

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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, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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