Employer Industry: Biopharmaceuticals

Why consider this job opportunity:
- Salary up to $120,000 USD
- Robust and market-competitive compensation and benefits package, including base pay, performance bonus, and equity
- Flexible PTO for a better work-life balance
- Opportunities for rapid career advancement for strong performers
- Collaborative, fast-paced, and data-driven work environment
- Commitment to Diversity, Equity & Inclusion

What to Expect (Job Responsibilities):
- Support the implementation and management of record management processes related to the electronic Trial Master File (eTMF) and ensure compliance with internal policies and external regulations
- Serve as the operational process and subject matter representative to the clinical study team, providing direction on documentation best practices
- Manage TMF Plans and Content Lists to ensure compliance and attention to detail
- Perform eTMF quality reviews, identifying document deficiencies and tracking them to resolution
- Facilitate QED TMF quality control activities and coordinate with CRO and study vendors for timely issue resolution

What is Required (Qualifications):
- Bachelor's degree in a scientific discipline or equivalent experience
- Minimum of 3-4 years of experience in the biotech/pharmaceutical industry or contract research organization (CRO)
- Knowledge of the DIA TMF Reference Model and Good Clinical Practice (GCP) requirements for TMF content
- Experience managing TMF documents and conducting TMF Quality Control activities
- Proficiency in managing large spreadsheets in MS Excel

How to Stand Out (Preferred Qualifications):
- Experience working in a CRO-owned eTMF system and User Access Management
- Previous participation in the validation of electronic document management systems/eTMFs
- Excellent organizational skills with a meticulous attention to detail
- Experience with process implementation and management principles
- Positive, team-oriented attitude

#Biopharmaceuticals #ClinicalResearch #CareerOpportunity #CompetitiveCompensation #DiversityAndInclusion

"We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."