TMF Specialist I/II

1 month ago

Canton, United States Organogenesis, Inc. Full time

About Us

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

The Organogenesis (OI) Trial Master File (TMF) Specialist plays a critical role in TMF compliance and Inspection Readiness. This position is actively involved in all TMF activities and works closely with cross-functional teams to ensure that all documentation is compliant with company Standard Operating Procedures (SOP), regulatory and GoodDocumentation Practices (GDP)

* How You Will Achieve It:

TMF Set-Up and Maintenance:


* Set-up the study in the Electronic Trial Master File (eTMF) system
* Collaborate with the functions to establish and maintain the study TMF
* expected document list
* Create and maintain study investigative site contacts and clinical site
* locations in the eTMF system
* Perform regular quality checks and audits of TMF contents to ensure
* completeness and accuracy
* Document Management:


* Review TMF documents to ensure comply with GDP, ALCOA+ quality
* requirements, and follows appropriate document naming conventions
* Responsible for filing documents into the eTMF system and/or
* reconciliation of document issues
* Involved with converting the paper/hybrid TMF documents to electronic,
* ensure meets quality requirements and files in the company eTMF system
* Regulatory Compliance:


* Stay up to date with relevant regulations and guidelines (e.g., ICH GCP,
* FDA, EMA) pertaining to TMF management
* Ensure that all TMF documents follow regulatory requirements and
* company standards
* Collaboration:


* Collaborate with functional study teams, contractors, company partners
* and/or third-party vendors in the support of all eTMF training and
* activities
* Training and Documentation:


* Provide training to clinical trial staff on TMF processes and best practices
* Maintain documentation related to TMF processes and procedures

Job Requirements

What You Need to Achieve It:

* Bachelor's degree in a related field (life sciences, healthcare, etc.).
* Minimum of 1-2 years of experience in clinical trial document management, with a strong focus on Trial Master File maintenance.
* Proficiency in regulatory guidelines and GCP standards.
* Experience with electronic document management systems (eTMF) is preferred.
* Excellent organizational skills and attention to detail.
* Strong communication and interpersonal skills.
* Ability to work independently and as part of a team.
* Proficient in Microsoft Office Suite (Word, Excel, Outlook).

What can we offer you?

* 401k -- generous employer match with immediate vesting and financial planning resources
* Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
* Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
* Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
* Paid maternity leave and parental leave for all new parents
* Adoption benefits
* Education Assistance Policy - $5,000 per year for all employees
* Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
* Employee Assistance Program
* Generous paid time off including vacation, floating holidays, sick days, and company holidays
* Free parking including an electric charging station (Canton and La Jolla)
* Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.

Physical Required

Job Type

Full-time

Location

Home Based Telecommute - US - US (Primary)

Education

Bachelor's Degree

Career Level

Individual Contributor

Travel

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