Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user ...
Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user ...
Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user ...
Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user ...
Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user ...
Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user ...
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Quick apply
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Prepare, draft, proofread, and file legal documents including pleadings, motions, affidavits ... Support litigation and trial preparation by organizing exhibits, evidence, trial binders, briefs ...
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Prepare, draft, proofread, and file legal documents including pleadings, motions, affidavits ... Support litigation and trial preparation by organizing exhibits, evidence, trial binders, briefs ...
Quick apply
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Quick apply
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Associate Attorney
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Trial Master File Associate information
What is a Trial Master File Associate?
A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.
What are the key skills and qualifications needed to thrive as a Trial Master File Associate?
To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.
What are some common challenges Trial Master File Associates face when managing clinical trial documentation?
Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.
What is the difference between Trial Master File Associate vs Clinical Trial Coordinator?
| Aspect | Trial Master File Associate | Clinical Trial Coordinator |
|---|---|---|
| Certifications | May require GCP or regulatory document management certifications | Often requires GCP training, clinical research certifications |
| Work Environment | Focuses on document management within clinical trials | Oversees trial operations, patient coordination, site management |
| Industry Usage | Commonly used in pharmaceutical and biotech companies | Used across clinical research sites and CROs |
The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.
What are the most commonly searched types of Trial Master File jobs in Chicago, IL?
The most popular types of Trial Master File jobs in Chicago, IL are:
What are popular job titles related to Trial Master File Associate jobs in Chicago, IL?
For Trial Master File Associate jobs in Chicago, IL, the most frequently searched job titles are:
What job categories do people searching Trial Master File Associate jobs in Chicago, IL look for?
The top searched job categories for Trial Master File Associate jobs in Chicago, IL are:
What cities near Chicago, IL are hiring for Trial Master File Associate jobs?
Cities near Chicago, IL with the most Trial Master File Associate job openings:
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 18 days ago
Abercrombie & Fitch rating
6.2
Based on 155 frontline employees who took The Breakroom Quiz
51st of 105 rated fashion retailers
Job description
We Make Life More Rewarding and Dignified
Location: Libertyville
Department: Clinical Affairs
Summary
The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The CDM regularly collaborates with Global Clinical Affairs (GCA) study team members (Clinical Project Management, Biostatistics, Clinical Operations, Clinical Scientist) and cross-functional departments to ensure high data quality. The position operates under minimal supervision and independently evaluates, selects, and applies data management practices to a variety of research projects.
Responsibilities
Design and Planning
- Lead the development of data management sections of clinical protocol and corresponding Case Report Forms (CRFs).
- Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user access forms, ensuring compliance with regulatory requirements
- Support each clinical study and project team by ensuring data management plans, questionnaire development, and data handling activities are aligned to support the study objectives.
- Participate in study team meetings
EDC Administration
- Design and program clinical study databases in EDC System including but not limited to CRFs, edit checks, data dictionaries, queries/alerts, and managing user roles based on the clinical protocol
- Lead User Acceptance Testing (UAT) to validate build specifications
- Train clinical research personnel on the study-specific CRF, EDC/ePRO, and other project related items as needed.
- Lead database clean, lock, export, and archiving activities.
- Oversee data management vendor relationships including EDC partners and CROs supporting DM tasks
- Continuously assess and enhance the EDC systems to improve efficiency and data quality
Data Monitoring
- Monitor clinical data to resolve queries and data discrepancies throughout each study according to Clinical Protocol and/or Data Management Plan
- Coordinates AE/DD reconciliation with PI
- Identify and communicate data issues and/or query trends to study team and/or management.
- Assist with developing metrics on study progress and routinely report out to study team and management.
Compliance and Process
- Ensure data management activities comply with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures.
- Contribute to the maintenance of GCA’s data management procedures and work instructions
- Responsible for leading or collaborating on process improvement initiatives within department
- Meet study timelines with a high degree of quality
- Other duties as needed or required.
Essential Functions of the Role
- Communicate effectively via email, phone, and virtual platforms.
- Prepare reports and dashboards for internal stakeholders.
- Ensure data accuracy and confidentiality in compliance with company and legal standards.
- Manage multiple priorities and deadlines in a fast-paced environment.
- Demonstrate initiative in identifying process improvements or automation opportunities.
- Serve as a point of contact for internal and external stakeholders.
- Resolve inquiries and issues with professionalism and discretion.
- Adhere to company policies, including those related to ADA, data privacy, and ethics.
- Maintain secure handling of sensitive information.
Education & Work Requirements
- Bachelor's Degree with 2-5 years of related experience
Education & Work Preferences
- Minimum of 2 years EDC database programming and Data Monitoring experience
- Minimum of 2 years medical device and/or pharmaceutical clinical research experience
- Certified Clinical Data Manager (CCDM) via SCDM or similar preferred
- Equivalent combination of education, training and work experience may be accepted in lieu of degree.
- Experience with EDC Systems (e.g. Medrio, Clinpal, Medidata Rave, etc.) required
- Understanding of clinical research regulations required
- Experience in questionnaire development, database structure, and data management processes
- Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams)
- Knowledge relating to continence care, critical care and/or ostomy a plus
Competencies
- Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
- Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
- Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
- Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
- Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.
Benefits Statement
Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.
- The anticipated base pay range for this position is $77,000 - $120,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
- If applicable: This position is also eligible to participate in the Hollister Secure Start Bonus Plan.
- The Company’s health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
- The Company’s 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions.
- The Company’s paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
- The Company’s additional benefits include: education assistance and adoption assistance benefit programs.
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.
EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job Req ID: 36304
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Industry
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Company size
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