Clinical Documentation Associate II
Company Description
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.
Job Description
“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
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Ensures real-time 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 'health' meetings and documents the discussion/decisions made in the TMF.
Develops and maintains study-specific 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
Bachelor's 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 cross-functional 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.
Key Stakeholders
Members of Clinical Documentation Center; colleagues in Development and Global Medical Affairs responsible for contributing/owning master file artifacts.
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 short-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 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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
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Clinical Documentation Associate II
Company Description
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.
Job Description
“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
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Ensures real-time 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 'health' meetings and documents the discussion/decisions made in the TMF.
Develops and maintains study-specific 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
Bachelor's 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 cross-functional 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.
Key Stakeholders
Members of Clinical Documentation Center; colleagues in Development and Global Medical Affairs responsible for contributing/owning master file artifacts.
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 short-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 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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