Study Management Associate III

AbbVie

Job Location:

Any - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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).

o 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

o Supports the development of the protocol

o 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.)

o Supports vendor selection defining scope of activities and oversight all vendors in compliance with AbbVies process and procedures

o Supports the management of investigational product and other associated study supplies

o Supports generation of study related training for the study team members study sites and selected vendors

o Remotely conducts routine monitoring of study data identifying study-level issues and/or trends; recommends mitigations

o 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).

o 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.)

o 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

Qualifications :

Bachelors Degree or OUS equivalent required degree in scientific field preferred; Associates 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 ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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

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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand 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:

Work :

Yes

Employment Type :

Full-time