Sr. Clinical Document Associate - Marlborough, MA | Biospace
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Sr. Clinical Document Associate


Marlborough, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Associates Degree
Areas of Expertise Desired:
Clinical Operations,

Job Description


•   The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

•   Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

•   AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.

Astellas is announcing a Sr. Clinical Document Associate opportunity in Marlborough, MA.

Purpose & Scope:

The purpose of this position is to:

•   Be responsible for the accurate and timely filing of clinical study and program related documents including both hardcopy and electronic documents
•   Be responsible for establishing files, photocopying/scanning and retrieving documents.
•   Perform QC of documents submitted by users
•   Provide input into establishment and improvement of document management standards and processes
•   Provide document support to study and program teams
•   The scope of this position covers activities associated with the conduct of Phase 1 through 4 AIRM- sponsored clinical studies.

Essential Job Responsibilities:

•   Perform the receipt and filing of hardcopy and electronic documents related to clinical studies and programs.
•   Process hard copy documents, review documents and file in appropriate folder structures. Process and lock scanned documents, review documents and file in appropriate folders.
•   Create new files as appropriate.
•   Fulfill record retrieval, photocopy and scan requests.
•   Provide appropriate and timely updates to users about document status.
•   Perform QC of documents to ensure the accuracy of hardcopy and electronic filing.
•   Participate in initiatives to establish or improve document management standards and processes.
•   Assist on special projects within area and train others in routine or specific tasks as needed; may provide direction to Clinical Document Assistant.

Quantitative Dimensions:

•   This position has a direct impact on compliance with related GCP/ICH guidelines in support of the conduct of AIRM-sponsored clinical studies.

Organizational Context:

•   This position reports to the Clinical Study Manager, Clinical Study Management or above. This position has no direct reports but may provide direction to Clinical Document Assistant.





•   Associate's Degree or equivalent required
•   Two to 4 years experience in records management or information services, preferably in the pharmaceutical industry.
•   Must have intermediate proficiency in document processing and archiving software and hardware systems. Demonstrated experience in working with electronic document management systems required.
•   General understanding of the clinical research and development process and experience handling associated documents preferred.
•   Strong problem solving and organizational skills and attention to detail.
•   Effective interpersonal skills.
•   Minimal domestic travel required.


•   Ophthalmology experience
•   Cell-based products/biologics clinical trial experience

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled.