Study Project Manager I
Study Project Manager I
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Salary Not Disclosed
1 Vacancy
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 multicountry 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 studyrelated training for the study team members study sites and selected vendors.
Responsible for regular updates to the crossfunctional 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 TAaligned 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 industryrelated 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 crossfunctional 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 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Project Management Methodology
- Project / Program Management
- Construction Estimating
- Construction Experience
- PMBOK
- Visio
- Construction Management
- Project Management
- Project Management Software
- Microsoft Project
- Project Management Lifecycle
- Contracts
