The Steely Group · 4 hours ago
Clinical Operations Specialist
Greater Boston
Contract
Hybrid
Senior Level
5+ years expThe Steely Group is seeking a Clinical Operations Specialist to maintain Trial Master Files (TMFs) ensuring they are current and inspection-ready. The role involves managing clinical document quality, supporting study leaders, and collaborating with various functional areas to enhance clinical document management processes.
ConsultingHealth CareHuman ResourcesMedicalStaffing Agency
Hiring Manager
Linda Briscoe
Responsibilities
Our client has a dedicated TMF Operations Team that supports the study team in managing TMF Activities
Responsible for managing clinical document quality/control/review, and the Trial Master Files (TMFs)
Performs set up activities, and oversight of internal e/TMF applications
Supports Clinical Operations Study Leaders in the QC and oversight of CROs’ e/TMF applications
Functional lead for specified e/TMF platform with vendor(s)
Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines
Provide training to eTMF users and external parties (CROs)
Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisions
Supports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate
Contributes to maintenance of written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document control
Updates and maintains Naming and Filing Guide(s) for relevant e/TMF systems
Work in collaboration with all applicable functional areas
Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate
Qualification
Required
Bachelor's degree or equivalent combination of education/experience in science or health-related field
Minimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization
Thorough knowledge of all sections of the TMF Reference Model (current & previous versions)
Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements
Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles
Preferred
Experience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc
Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals
Experience working with multiple eTMF vendors and CRO partners
Motivated self-starter who is capable of flourishing in a fast-paced small company environment
Creative problem solver with excellent communication and public speaking skills
Proficiency in developing and delivering educational materials, both written and oral
Ability to engage in cross-functional interactions with internal and external staff
Global trial experience
Strong interpersonal and organizational skills are needed, with a high degree of attention to detail
Company
The Steely Group
The Steely Group offers clinical, healthcare, and human resource recruitments and staffing solutions.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Giovanni Oriente
Chief Financial Officer
Jay VanHousen
Sr Director, Clinical and Scientific Partnerships
Recent News
2025-10-23
Company data provided by crunchbase