Generate, organize, deliver TMF performance metrics for various functional areas
Support Trial Operations with the TMF implementation and throughout the study as needed with oversight by the designated Clinical Programs Manager(s) and Clinical Trial Managers CTM(s)
Perform risk-based periodic reviews of quality issue responses and document quality reviews, as needed, on site, country, or study level or as delegated by Trial Maintenance Management
Perform document review for suitability, content, legibility, and conformance with good documentation practices (GDP)
Respond to or delegate TMF alerts, tasks, and quality issues as TMF Subject Matter Expert (SME)
Raise quality issues for TMF issues found, as applicable
Ensure similar documentation issues are handled uniformly across all trials/programs
Exhibit knowledge of applicable FDA, ICH/GCP guidelines to perform review on documents that have been filed to the TMF and to support inspection readiness goals
Participate in project specific meetings and educate functional leads in TMF requirements
Ensure accurate completion and maintenance of TMF
Demonstrate ability to make sound business decisions based on evidence (SOPs and guidance documents) and experience, deliver on commitments, share knowledge, acknowledge other achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Requirements

Bachelor’s degree with 3+ years of relevant Trial Master File experience; or High School diploma with 6+ years relevant clinical research experience
Experience in study start-up, study maintenance and document quality reviews preferred
Relevant experience in clinical trials related roles (i.e. clinical operations and project management) preferred
Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable
Experience with eTMF maintenance preferred
Veeva Vault experience preferred
Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; previous interaction with operational project teams preferred
Ability to adapt to a changing environment and handle multiple priorities
Detail and process oriented
Superb organizational and time management skills
Flexible and adaptable to a developing work environment; willingness to learn
Positive attitude and approach
Excellent communication skills, oral and written
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in a team environment
Interact with internal and external sites and vendors with high degree of professionalism and discretion
Multi-tasking capability
Computer proficiency (MS Office - Word, Excel, Power Point), aptitude for training, capable of operating standard office equipment and learning new systems

Benefits

Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Trial Master Filedocument quality reviewseTMF maintenanceproject managementstudy start-upstudy maintenancerisk-based reviewsgood documentation practicesinspection readinessmulti-tasking

Soft Skills

organizational skillstime managementadaptabilitycommunication skillsself-motivationcollaborationattention to detailflexibilityprofessionalismproblem-solving