Clinical Study Assoc II Remote

Master File Owner responsible for managing and ensuring inspection readiness of clinical documentation / master files. CDC representative on study team(s) with ownership of the study Trial Master File (TMF).

Responsibilities: 

• Ensures realtime inspection readiness of clinical documentation / TMF by performing quality control (QC) of the TMF / artifacts to ensure completeness document quality and timeliness of upload of artifacts to the TMF.
• Collaborates with Artifact owners; holds study team members accountable for respective sections of the TMF reports status to study team members by providing regular status updates & facilitating / leading routine TMF meetings and documents the discussion/decisions made in the TMF.
• Develops and maintains studyspecific TMF structure documentation (i.e. Expected Document List excel trackers for paper/hybrid TMF).
• Provides support and prepares TMF(s) for audits/inspections.
• Contribute to (may lead) functional area continuous improvement projects and/or work streams.
• Provide input and/or recommendations to SOPs Work Instructions and Job Aides.
• Complies with GCP AbbVie SOPs and function area processes.

Qualifications :

• Bachelors degree required with min. 2 years relevant industry experience in clinical document management or equivalent experience.
• Proven analytical and critical thinking skills.
• Operates with limited oversight.
• Good oral and written communication skills; ability to facilitate crossfunctional team meetings.
• Ability to manage several projects at the same time.
• Competent knowledge of clinical documentation business procedures.
• Ability to independently work in clinical documentation system.

This is a remote opportunity candidates are able to work anywhere in the US. 

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. 

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 serving our community and embracing diversity and inclusion.  It is AbbVies 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.

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