Clinical Document Management Specialist

Role Summary

The Clinical Document Management Specialist supports clinical trials by processing both paper and electronic essential study documents against pre-specified quality criteria to include filing, routing, and coordination of documents to ensure compliance with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.

Responsibilities

• Provides operational and administrative guidance for the study TMF/eTMF by assisting with the setup, organization, maintenance, and close-out of study specific TMF/eTMF.
• Maintains and updates of Company’s standard TMF Plan and TMF index, including indexing, tracking, and filing of paper and electronic clinical trial documents.
• Maintains the study TMF filing records system.
• Collaborates with the Clinical Study teams to guide proper submission and/or filing of clinical study related documents for completion of required tasks to meet departmental and project goals.
• Performs and oversees a review of documents filed in the TMF/eTMF as outlined by SOPs, company processes, procedures, and work instructions.
• Overwatch in preparing, handling, distributing, filing and archiving of clinical documentation and reports per standard procedures.
• Collaborates in the review and improvement of SOPs and Departmental Policies and Procedures as it relates to TMF maintenance and archiving.
• Performs the regularly scheduled QC of the overall TMF/eTMF per the TMF Plan by monitoring completeness and quality of the TMF.
• Maintains internal audits and Regulatory Agency inspections by retrieving documents and providing reports.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Qualifications

• Required: Bachelor’s degree with 1+ years of clinical operations experience in pharma, biotech or CRO; or High School diploma with 4+ years of clinical operations experience in pharma, biotech or CRO.
• Trial Master File experience preferred.

Skills

• Demonstrated knowledge of ICH and GCP guidelines.
• Demonstrated knowledge of clinical trial documents is preferred.
• Proficiency in MS Word, Excel, PowerPoint, Outlook.
• Independent, flexible, team-oriented, self-directed, and able to adapt to changing priorities and meet deadlines.
• Understand job-specific systems and processes as defined by Company SOPs and adhere to requirements; escalate ambiguities to supervisor/manager.
• Strong communication skills and customer focus with the ability to interact in a cross-functional organization.
• Maintain corporate confidentiality and dependability/timeliness.
• Critical thinking, ability to lead co-workers, strong attention to detail, and strong document organization, prioritization, scheduling, and deadline management.

Education

• Bachelor’s degree with 1+ years of clinical operations experience in pharma, biotech or CRO required; or High School diploma with 4+ years of clinical operations experience in pharma, biotech or CRO required.
• Trial Master File experience preferred.

Additional Requirements

• This position works on-site in El Segundo, CA or Remote.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• Requires being at a computer for several hours at a time.
• On-call during audits.