Clinical Documentation Associate II

The Clinical Document Management Associate II will ensure the Master File is always inspection-ready and complies with ICH GCP guidelines. This role entails the conduct of rigorous quality checks ensuring reliable and complete Trial Master File. Collaborate with study teams providing support to address and resolve issues related to Master File health indicators. Focus on maintaining the completeness accuracy and timeliness of all crucial documents throughout the lifecycle of the assigned clinical trials.

Responsibilities

• Actively engages with document owners to ensure that study team members are accountable for their respective sections of the Master file.
• Work collaboratively with document owners and cross-functional teams to resolve document-related issues and harmonize documentation practices. Actively engages with document owners to resolve quality issues during the document filing process.
• Prepares and delivers detailed reports and presentation materials to stakeholders as well as contributes to and potentially leads internal Business Process Teams and initiatives focused on continuous improvement projects and work streams.
• Offers valuable input and recommendations for Standard Operating Procedures (SOPs) work instructions and job aids serving as a subject matter expert and potentially mentoring new hires.
• Prepares and distribute periodic Master File Oversight emails and reports conduct Master File Oversight Quality Assessments and initiate actions for functional area reviews.
• Proactively escalates and resolves issues related to Master File completeness timeliness and quality ensuring that any challenges are addressed promptly and efficiently. Maintain a consistent reporting format and frequency.
• Creates and presents reports to study teams collaborating with functional areas to finalize and archive study Master Files in the electronic Master File system and supporting audit and inspection preparations to ensure Master File readiness.
• Continuously monitor TMF Health metrics to detect emerging trends identify potential risks and implement effective mitigation strategies to ensure document integrity and compliance.
• Offers expert input and recommendations for Standard Operating Procedures (SOPs) work instructions and job aids serving as a subject matter expert.
• Provide training and support to new team members serving as a mentor to guide best practices in document management and conducts QC Checks on document processing of internal and external staff to ensure quality thresholds are being met.

Qualifications :

• Bachelors degree or international equivalent preferred. Minimum 4 years relevant industry experience in clinical document management or equivalent experience required.
• If no bachelors degree a total of 6 years professional clinical research relevant work experience.
• Proven analytical and critical thinking skills.
• Proficient knowledge of clinical documentation business procedures.
• Capable of working autonomously with limited oversight.
• Proven oral and written communication skills; ability to facilitate cross-functional team meetings.
• Compliant to clinical documentation processes identify gaps and propose solutions.
• Collaborative mindset to work effectively across various teams and departments.
• Excellent organizational skills with the ability to manage several projects at the same time.
• Experienced in using Microsoft PowerPoint and Excel.

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 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:

Work :

No

Employment Type :

Full-time