Reporting to the Clinical Documentation Team Lead, the Clinical Document Specialist is responsible for the management of clinical study records (e.g. clinical Trial Master File) from set up through to final archival, ensuring compliance with company SOPs and process.
With a focus on inspection readiness, monitors clinical Trial Master File (TMF) compliance and is responsible for preparation of documentation required for regulatory agency inspection and internal audits.
Oversees set up and consolidation of outsourced elements of the Clinical TMF with preferred CRO vendors. Performs periodic quality assessments of clinical TMF documents where required.
Responsible for delivering assigned Clinical Document Management (CDM) initiatives. Mentors CDM staff on document management process.
Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of CDO ensuring effective life cycle management of the clinical section of the Trial Master File (TMF).
• Key contributor to the clinical study team.
• Monitors completeness and quality of the Clinical TMF, including elements outsourced to CRO.
• Ensures effective communication and issue escalation internally and with external vendor.
• Oversees consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process.
• May fulfill the role of the Designated Clinical Archivist for GCDO.
Leads collaboration across R&D to agree study specific TMF. Oversees the consolidation of the R&D TMF across functions and external vendors at the end of the study
Supports inspection readiness for GCDO through periodic quality assessment of clinical records
• Ensures clinical records are filed in a timely manner
• With direction from the CDM Lead, prepares clinical records for agency inspection.
• Manages assigned TMF corrective action plans under direction of CDM Lead.
Represents CDM by presenting and training on document management processes to functional departments and external vendors.
• Acts as mentor for CDM, providing training and support around clinical document management activities.
• Supports CDM led initiatives to enhance efficiencies in document management
Education & Experience Requirements:
• Minimum 5 years of pharmaceutical industry experience related to clinical document management
• Familiarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices. Current awareness of regulatory requirements for clinical trials (ICH/GCP, FDA, EU Directive).
• Bachelor's degree or equivalent preferred
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.