Provide operational and subject matter expertise (SME) and support to program/project teams to ensure that study eTMF documents are audit and inspection ready by working collaboratively with cross-functional teams, e.g., data management and regulatory, etc., and external partners / stakeholders.
As main point-of-contact (POC) for study eTMFs, plans and manages day-to-day operational aspects of one or more assigned eTMF programs/projects or tasks, including the following, as required: planning/timelines, budgeting, resourcing, and vendor management / interfacing, as required. Identifies and proactively works to remove obstacles, mitigate risks, and escalates issues; both internally and to the client [COR, or designee(s)], as needed. Includes serving as the subject matter expert on domestic/international documentation requirements.
Maintain and manage eTMF operations including metadata specifications, filing, and quality control (QC) of all study documents from set-up to archival.
Ensure documentation flow is within projected timelines and determine course of action to prevent and remediate delays.
Maintain study specified document lists at the study, country, and site levels by to ensure documentation is in place and all versions/instances are filed in a timely fashion.
Create and maintain study-specific eTMF Plans, Indexes, tracking tools, and project files, as needed.
Able to lead eTMF educational workshops and trainings.
Interface with client and program/project staff; ensure provision of meeting agendas and summary documentation and /or detailed information as required for internal and client meetings. Prepare sections for monthly, quarterly, and annual reports; and present at internal and/or scientific meetings.
Ensure project quality and compliance with FDA regulations and ICH E6(R2) guideline, and with NIH policies or other sponsors-specific requirements.
Develop TMF/eTMF related SOPs, forms, and plans, to ensure compliance.
Perform duties within established SOPs and in accordance with Good Clinical Practice (GCP).
Perform verification and quality control of essential regulatory documents to ensure that the eTMF is complete, contemporaneous, and quality ensured.
Manage eTMF projects and perform a risk-based review of eTMF activities and content, to include monitoring internal/external KPIs.
Monitor and identify study specific eTMF trends and escalate concerns.
Support and comply with the company's Quality Management System policies and procedures. Provide oversight and mentorship to staff in the delivery of quality work and performance, as per task order and/or project deliverables. Drive innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed.
Contribute to Corporate Initiatives, e.g., SOPs, risk reviews, and business proposals.
Bachelor's Degree in life science or another health-related field (Master's Degree a plus)
5+ years minimum in Pharma/Biotechnology industry including Contract Research Organization (CRO) or other clinical trials environment; e.g., hands on regulatory, clinical operations (in-house CRA/study coordinator), or site monitoring experience
Working knowledge of FDA/EMA and other regulatory requirements, GCPs/ICH (R2) guidelines and hands on regulatory, clinical operations, or clinical trial monitoring experience.
Expert knowledge of clinical study files documents, eTMF Reference Model, clinical trial activities, and terminology.
Excellent leadership skills with demonstrated ability to take a leadership role and drive quality progress for a diverse team with specialized expertise. Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
Display excellent organizational skills and exhibit professionalism and integrity.
Demonstrated project/task management skills, with team member oversight, will include line management responsibility and staff hiring.
Strong presentation, problem-solving, and conflict resolution skills.
Seasoned oral and written communication skills.
Expertise in Microsoft Word, PowerPoint, and Excel is required, and experience with Microsoft Project a plus.
Background in Infectious Disease/HIV clinical trials and/or Oncology preferred; prior work on a government contract, is a plus.
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According to the US Bureau of Labor Statistics (BLS), employment in life, physical, and social science occupations is projected to grow 5 percent from 2019 to 2029, faster than the average for all occupations, and will result in about 68,200 new jobs. Increasing demand for expertise in the sciences, particularly in occupations involved in biomedical research, psychology, energy management, and environmental protection, is projected to result in employment growth.
According to BLS, the median annual wage for life, physical, and social science occupations was $69,760 in May 2020, which was higher than the median wage for all occupations of $41,950.
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