Study Project Manager II

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 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, strategic thinking, a global mindset and innovative solutions to address operational risks and challenges.

Responsibilities

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

·       In partnership with the Global Therapeutic Medical/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’s processes and procedures and the 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 with proposed mitigation.

·       Analyzes metrics and recommends appropriate action as necessary.

·       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 oversight of contractors.

·       Bachelor’s Degree or international equivalent is required; degree in scientific field preferred.

·       Must have at least 8 years of Pharmaceutical industry related experience or 6 years of experience with an advanced degree.

·       Demonstrates a high level of core and technical competencies through management of various components of clinical studies.

·       Exposure in study initiation through study completion, specifically experience with study start-up and primary data analysis.

·       Proven good presentation and communication skills; good project management and leadership skills, with proven ability to successfully facilitate cross-functional team meetings.

·       Proven analytical and critical thinking skills; skilled at problem solving at operational and tactical levels.

·       Operates independently, escalates issues with proposed action/mitigation plan.

·       Capable of meeting changing business and regulatory requirements.

·       Experience successfully coaching/mentoring in a matrix environment; direct people management is desirable.

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

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