· Excellent knowledge of ICH-GCP guidelines and FDA/EMA/PMDA regulations
· Excellent working knowledge of clinical study documentation
· Very good IT proficiency with ability to easily learn new technologies
· Ability to understand technical, scientific and medical information
· 4-6 years relevant experience within the Pharmaceutical industry/ Clinical Research
· Understanding of drug development process and concepts of clinical research
· Proficient in MS Office, MS Excel; able to work with databases
· Bachelor's degree or equivalent education
· Scientific degree or Professional Records Manager Degree is an advantage
· The Record Manager will provide support to the Development team for the conduct of Clinical Trials according to ICH-GCP and local and international applicable regulations.
· The Record Manager is accountable for implementation and maintaining control of record management processes related to the electronic Trial Master File (eTMF) and to ensure compliance with internal policies as well as external regulations.
· The Record Manager ensures GxP inspection readiness for Clinical Study TMF documentation and records for inspection by internal or regulatory agencies.
· Additionally the Record Manager provides Subject Matter Expertise ensuring that project documentation is maintained to the highest level of quality and compliance while aligning with company and departmental objectives.
· In collaboration with the Clinical Trial Manager, ensures high quality TMF set-up and management (on-boarding of study contributors, completion of the TMF management plan, study specific preparation of documents in the system, periodic reviews, etc.)
· Manages document control processes and systems for GCP activities in compliance with internal procedures and policies as well as regulatory requirements:
o Maintains the eTMF records management system including secure storage, retrieval, retention and destruction per Company SOPs
o Manages the day-to-day routing, review (including for accuracy and completeness), approval, distribution and archival of clinical documents in accordance with the Company SOPs and ICH GCP, ensures compliance with relevant legislation and regulations
o Manages TMF Record integrity whether paper (ink) or electronic
o Performs internal periodic quality check (QC) activities of the TMF, provides findings to the clinical team and provides support to the team to ensure compliance is maintained
o Performs pre-Audit/Inspection review of TMF (Trial Master File) and ISF (Investigator Site File) documentation in accordance with Company SOPs
· Ensures TMF record management documents and processes are periodically reviewed for relevance to ensure actual practices are reflected as defined in applicable procedures and are in compliance with regulatory requirements
· Provides support to clinical teams during regulatory inspections for record organization and retrieval
· Prepares regular metrics and status reports on Document Control for Clinical Trial Management review
· Trains and mentors study teams in TMF documentation, archiving and filing
· Follows up on open record management queries and ensures their full resolution
WHY WE'RE NOW ONE: Combining the integrated capabilities of a CRO (Contract Research Organization) and a CCO (Contract Commercial Organization) addresses new market realities through Clinical and Commercial sharing expertise, data and insights to meet the needs of global biopharmaceutical companies of all sizes.
SINGULAR GOAL: We're one company, purpose-built to achieve a singular goal: Biopharmaceutical Acceleration. Creating better, smarter, faster ways to speed products to market.
OUR SHARED PURPOSE: We will incorporate the best practices and processes of INC Research and inVentiv Health to shape a company that's a far better fit for the modern biopharmaceutical world. We share one purpose...Shortening the distance from lab to lifeTM.
Role: TMF Analyst/Document Specialist
Location: San Diego Country Estates,
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